Proactiveinvestors Australia Zelda Therapeutics Ltd https://www.proactiveinvestors.com.au Proactiveinvestors Australia Zelda Therapeutics Ltd RSS feed en Tue, 23 Jul 2019 21:38:01 +1000 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Zelda Therapeutics teams up with medicinal cannabis clinic network ]]> https://www.proactiveinvestors.com.au/companies/news/224172/zelda-therapeutics-teams-up-with-medicinal-cannabis-clinic-network-224172.html Zelda Therapeutics Ltd (ASX:ZLD) has entered into a strategic collaboration agreement with Emerald Clinics to access clinical data from patients treated with medicinal cannabis for pain and insomnia.

Emerald Clinics owns and operates an Australian network of dedicated medicinal cannabis clinics.

Zelda will us this access to real world patient data for its ongoing clinical trial work focused on developing new cannabis-based treatments to reduce opioid usage in patients with chronic pain as well as patients with insomnia and autism.

READ: Zelda Therapeutics responds to ASX query on price and volume increases

Zelda’s managing director Dr Richard Hopkins said: “Australia’s commitment to developing a highly regulated market for prescription cannabis medicines means this country is now a global leader in collection of high-quality longitudinal clinical data relating to patients treated with medicinal cannabis.

“We believe Emerald’s approach to collection and curation of patient data makes this information a very valuable commodity world-wide.”

Option to access future data of patients using Zelda-branded producted

The agreement also includes an option for Zelda to access real-world data collected from patients prescribed Zelda-branded cannabis products, which the company is aiming to bring to market in 2020.

Hopkins added: “Being able to access real-world data, in real-time, from patients treated with regulated cannabis medicines – including, in the near future, our own clinically validated products – will provide Zelda with a significant competitive advantage.

“This information will inform the design of future clinical trials, reduce the risks and costs of development and accelerate the path to market.

“These key value-adding features will further differentiate Zelda from its global peers and enhance the commercialisation opportunities for the company.”

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Fri, 19 Jul 2019 08:50:00 +1000 https://www.proactiveinvestors.com.au/companies/news/224172/zelda-therapeutics-teams-up-with-medicinal-cannabis-clinic-network-224172.html
<![CDATA[News - Zelda Therapeutics responds to ASX query on price and volume increases ]]> https://www.proactiveinvestors.com.au/companies/news/223729/zelda-therapeutics-responds-to-asx-query-on-price-and-volume-increases-223729.html Zelda Therapeutics Ltd (ASX:ZLD) was queried by the ASX yesterday relating to the price of its securities, which went from a low of 4.6 cents at the close of trading on July 8 to a high of 6.7 cents yesterday, July 10.

The ASX also noted the increase in the volume of Zelda’s securities traded during the same period.

Zelda responded to the query explaining that it was not aware of any information that had not been released to market which, if known by some in the market, could explain the recent trading in its securities.

The company also reconfirmed that it recently received formal approval for its Phase I Opioid Reduction Trial from the St Vincent’s Hospital Ethics and Governance Committees.

READ: Zelda Therapeutics to begin opioid reduction trial with approval granted

The Phase I trial will evaluate the safety and tolerability of whole plant extract following single and repeated doses in nine patients with chronic non-cancer pain on long-term opioid analgesia.

Secondary outcomes include pharmacokinetics and the effects on pain, mood, sleep and opioid use over the duration of the trial.

The Phase I trial has commenced with preliminary results expected by late Q3 2019 and final results in Q4 2019, which is similar to the timeframe the company expects to report on its ongoing Phase II Insomnia trial.

Zelda’s CEO has also continued to make presentations in relation to the company’s business and its objectives, which have been well attended by investors.

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Thu, 11 Jul 2019 17:10:00 +1000 https://www.proactiveinvestors.com.au/companies/news/223729/zelda-therapeutics-responds-to-asx-query-on-price-and-volume-increases-223729.html
<![CDATA[News - Zelda Therapeutics to begin opioid reduction trial with approval granted ]]> https://www.proactiveinvestors.com.au/companies/news/223158/zelda-therapeutics-to-begin-opioid-reduction-trial-with-approval-granted-223158.html Zelda Therapeutics Ltd (ASX:ZLD) has been granted approval for its Phase I Opioid Reduction trial by the Ethics and Governance Committees at St Vincent's Hospital in Melbourne with the trial now underway.

This trial will evaluate the safety and tolerability of whole plant extract following single and repeated doses in nine patients with chronic non-cancer pain on long-term opioid analgesia.

Secondary outcomes include pharmacokinetics and the effects on pain, mood, sleep and opioid use over the duration of the trial.

READ: Zelda Therapeutics on rapid path to medicinal cannabis commercialisation

The outcomes of the trial will inform a subsequent larger scale phase II study that will assess the impact of oral whole plant extract on patient ability to tolerate a stepped opioid tapering protocol.

Zelda managing director Richard Hopkins said he was delighted to have the trial underway.

He said: “To our knowledge this is the first clinical trial to be designed with a primary end point assessing the efficacy of a full spectrum plant derived cannabis formulation containing THC and CBD to reduce opioid dependence in chronic non cancer patients.

“If successful, the outcome of these trials will likely have immediate impact in major global markets where opioid overuse and addiction is a major problem.”

Shares were up almost 10% in early trade to 4.6 cents.

READ: Zelda Therapeutics to use Federal Government R&D tax rebate of 769,000 to drive clinical trials

Prescription opioids treating chronic pain are linked to serious side effects including physical dependence, which is an acknowledged growing global crisis.

In the United States an estimated 49,000 people died from opioid overdose in 2017.

In May Hopkins updated investors at Proactive’s CEO Sessions in Sydney and Melbourne on its position to service a rapidly growing global market.

He said the company was building a portfolio of clinically validated assets which presented multiple revenue opportunities to license and generate milestone and royalty payments.

This strategy is well advanced because the company has a singular focus on clinical validation to address key unmet needs.

Zelda also obtained $769,000 under the Federal Government's R&D Tax Incentive Scheme in order to accelerate clinical trials and a pre-clinical program.

 

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Tue, 02 Jul 2019 10:26:00 +1000 https://www.proactiveinvestors.com.au/companies/news/223158/zelda-therapeutics-to-begin-opioid-reduction-trial-with-approval-granted-223158.html
<![CDATA[News - Zelda Therapeutics gains new strategic investor in Merchant Funds Management ]]> https://www.proactiveinvestors.com.au/companies/news/221826/zelda-therapeutics-gains-new-strategic-investor-in-merchant-funds-management-221826.html Zelda Therapeutics Ltd (ASX:ZLD) has gained a new strategic investor in leading boutique investment management group Merchant Funds Management which has obtained a 3.6% stake.

This was facilitated by the sale by Zelda's founder and director Mara Gordon of 35.5 million shares, of which Merchant acquired 26,931,660.

The sale by Gordon represented part of her holding in Zelda and she retains more than 44 million shares while remaining on the company's board.

Zelda worked with CPS Capital Group to facilitate this investment by Merchant.

READ: Zelda Therapeutics on rapid path to medicinal cannabis commercialisation

The company's managing director Richard Hopkins said: “We are delighted to have secured Merchant as a strategic investor in Zelda and welcome their long-term support.”

Merchant Funds managing director Andrew Chapman said: “Merchant was an early mover into the Australian medical cannabis sector and enjoys a long association with some of the founders of Zelda.

“We believe Zelda has the potential to create significant shareholder value over the next 12 months as clinical trials complete and international commercialisation commences.

“Developing novel intellectual property combined with a clear path to market is a valuable position to occupy in this rapidly expanding global industry.”

READ: Zelda Therapeutics to use Federal Government R&D tax rebate of $769,000 to drive clinical trials

Following this change in shareholding, the board of Zelda now holds a combined 204,222,646 shares representing 27% of issued capital and remains focused on growing shareholder value.

On November 7, 2018, the board confirmed the commitment to not sell equity securities they own or control unless to help facilitate a major investment by a strategic investor.

Zelda welcomes the support of Merchant who has a long and successful track record in the Australian medicinal cannabis sector.

 

 

Last month Hopkins presented at Proactive’s CEO Sessions in Sydney and Melbourne and told investors that the company was well placed to service a rapidly growing global market.

He said the company was building a portfolio of clinically validated assets which presented multiple revenue opportunities to license as well as generate milestone and royalty payments.

This strategy was well advanced because the company had a singular focus on clinical validation to address key unmet needs.

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Tue, 11 Jun 2019 10:10:00 +1000 https://www.proactiveinvestors.com.au/companies/news/221826/zelda-therapeutics-gains-new-strategic-investor-in-merchant-funds-management-221826.html
<![CDATA[News - Zelda Therapeutics on rapid path to medicinal cannabis commercialisation ]]> https://www.proactiveinvestors.com.au/companies/news/220472/zelda-therapeutics-on-rapid-path-to-medicinal-cannabis-commercialisation-220472.html Zelda Therapeutics Ltd (ASX:ZLD) is on a rapid path to commercialisation of its medicinal cannabis products aimed at treating pain, anxiety, sleep apnea and cancer.

The company’s managing director Dr Richard Hopkins told investors at this week’s Proactive CEO Sessions in Sydney and Melbourne that the company is well placed to service a rapidly growing global market.

READ: Zelda Therapeutics to use Federal Government R&D tax rebate of $769,000 to drive clinical trials

He said the company was building a portfolio of clinically validated assets which presented multiple revenue opportunities to license and generate milestone and royalty payments.

This strategy was well advanced because the company had a singular focus on clinical validation to address key unmet needs.

Market dynamics

Among the interesting medicinal cannabis market dynamics outlined were:

Medicinal cannabis is legal in more than 34 countries and in 35 US states; Only around 1% of the population in the US and Canada is registered to use medicinal cannabis; The medicinal cannabis market is forecast to grow to $40-55 billion by 2028 (18% CAGR); Around US$20 billion has been raised by medicinal cannabis companies over the last four years; and 21 kilograms is the amount of cannabis required to consume for a lethal dose.

Zelda has a number of upcoming catalysts including results of three first-in-class clinical trials, an insomnia trial, observational autism trial and opioid reduction trial, which are due in the second half of 2019.

Among the recent highlights are an expanded pre-clinical program for cancers and cognitive decline, and a manufacture and German distribution agreement with Hapa Medical BV.

Zelda has also established partnerships with US-based Ilera Healthcare to access more than 110,000 patients and with Suda to develop proprietary oral mucosal formulations.

Read Dr Richard Hopkins presentation.

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Fri, 17 May 2019 13:43:00 +1000 https://www.proactiveinvestors.com.au/companies/news/220472/zelda-therapeutics-on-rapid-path-to-medicinal-cannabis-commercialisation-220472.html
<![CDATA[News - Zelda Therapeutics to use Federal Government R&D tax rebate of $769,000 to drive clinical trials ]]> https://www.proactiveinvestors.com.au/companies/news/219924/zelda-therapeutics-to-use-federal-government-rd-tax-rebate-of-769000-to-drive-clinical-trials-219924.html Zelda Therapeutics Ltd (ASX:ZLD) will use the $769,000 cash refund it received under the Federal Government’s R&D Tax Incentive Scheme to accelerate current clinical trials as well as a pre-clinical program.

The R&D Tax Incentive Scheme is an Australian Government program where companies receive cash refunds of 43.5% if eligible expenditure is on research and development.

READ: Zelda Therapeutics to outline cannabinoid-based strategy at Proactive CEO sessions

The refund positions Zelda well as it advances its current:

Human clinical trial program – focused on insomnia, autism and opioid reduction with activities in Australia and the USA; and Pre-clinical research program – examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

 

 

The company conducts this work in partnership with world-leading researchers and organisations such as Complutense University in Spain, Curtin University in Western Australia, the Telethon Kids Institute in Perth, the University of Western Australia and the Children’s Hospital of Philadelphia in the United States.

In March 2019 Zelda was awarded a patent to detect breast cancer, which details a method for detecting levels of expression of a novel receptor complex containing HER2 and CB2 (types of protein).

HER2 is a well-recognised marker of aggressive breast cancer while CB2 is a key receptor in the endocannabinoid system.

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Thu, 09 May 2019 09:48:00 +1000 https://www.proactiveinvestors.com.au/companies/news/219924/zelda-therapeutics-to-use-federal-government-rd-tax-rebate-of-769000-to-drive-clinical-trials-219924.html
<![CDATA[News - Zelda Therapeutics to outline cannabinoid-based strategy at Proactive CEO Sessions ]]> https://www.proactiveinvestors.com.au/companies/news/219529/zelda-therapeutics-to-outline-cannabinoid-based-strategy-at-proactive-ceo-sessions-219529.html Zelda Therapeutics Ltd (ASX:ZLD) is developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions, with a focus on cancer therapies.

The company is undertaking:

• A human clinical trial program focused on insomnia, autism and opioid reduction with activities in Australia and the USA.

• A pre-clinical research program examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

Zelda managing director Dr Richard Hopkins will present to investors at the Sydney investor event on Monday, May 13 and at the Melbourne event on Tuesday, May 14.

Range of commercialisation opportunities

Zelda’s recent developments include a heads of agreement (HoA) with medicinal cannabis company Ilera Healthcare to explore collaborative opportunities and being granted a new patent covering a novel method to predict patient disease-free survival.

The range of commercialisation opportunities with US-based Ilera include licensing of Zelda products, co-development and data sharing.

READ: Zelda Therapeutics secures patent to detect breast cancer

Zelda’s Australian patent details a method for detecting levels of expression of a novel receptor complex containing proteins HER2 and CB2.

HER2 is a recognised marker of aggressive breast cancer while CB2 is a key receptor in the endocannabinoid system.

Register for the CEO Sessions today

Sydney details, Monday, May 13, 2019

Melbourne details, Tuesday, May 14, 2019

Also featuring at both sessions will be Xanadu Mines Ltd (ASX:XAM), Infinity Lithium Ltd (ASX:INF), Oventus Medical Ltd (ASX:OVN and Invitrocue Ltd (ASX:IVQ).

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Thu, 02 May 2019 15:16:00 +1000 https://www.proactiveinvestors.com.au/companies/news/219529/zelda-therapeutics-to-outline-cannabinoid-based-strategy-at-proactive-ceo-sessions-219529.html
<![CDATA[Media files - Ilera Healthcare deal is 'one piece of the puzzle' for Zelda Therapeutics in 'globalising product' ]]> https://www.proactiveinvestors.com.au/companies/stocktube/12562/ilera-healthcare-deal-is--one-piece-of-the-puzzle--for-zelda-therapeutics-in--globalising-product--12562.html Tue, 12 Mar 2019 15:03:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/12562/ilera-healthcare-deal-is--one-piece-of-the-puzzle--for-zelda-therapeutics-in--globalising-product--12562.html <![CDATA[News - Zelda Therapeutics in deal with Ilera to access US market ]]> https://www.proactiveinvestors.com.au/companies/news/216230/zelda-therapeutics-in-deal-with-ilera-to-access-us-market-216230.html Zelda Therapeutics Ltd (ASX:ZLD) has entered into a binding heads of agreement (HoA) with US-based medicinal cannabis company Ilera Healthcare, LLC to explore collaborative opportunities.

The broad range of commercialisation opportunities includes licensing of Zelda products, co-dev elopement and data sharing.

No upfront payments will be received initially however the terms provide for both parties to negotiate separate additional commercial agreements.

READ: Zelda Therapeutics secures patent to detect breast cancer

Zelda’s managing director Dr Richard Hopkins said: “We’re delighted to formalise our partnership with Ilera, which is designed to leverage the strong synergies between our companies.

“As a vertically integrated company, Ilera’s strengths in cultivation, extraction/formulation and distribution are complemented by Zelda’s expertise in clinical validation, product differentiation and downstream value-adding.

“Given the current barriers to undertaking clinical trials using medicinal cannabis at the Federal level in the US, Zelda can help fast-track clinical validation of Ilera products while Zelda potentially gains access to a significant North American market for its products.”

Partnerships now provide access to 110,000 patients globally

This partnership reinforces the global breadth of Zelda’s relationships and shows our focus on commercialising our clinically validated formulations.

“When considered alongside our recent manufacturing and distribution agreement with HAPA in Germany, our partnerships provide access to over 110,000 registered medicinal cannabis patients globally which is approximately 30 times larger than the current Australian market.”

Deal unlocks value for both parties

Ilera noted that entering the partnership with Zelda was part of its strategy to extend the reach of its research and product development around the world.

Ilera’s installed capacity to formulate specific medicines, its commercialisation expertise combined with its executive teams’ global experience creates a unique opportunity for this partnership to deliver condition-specific cannabinoid-based medicines to the global stage.

READ: Zelda Therapeutics reflects on busy December half

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Tue, 12 Mar 2019 09:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/216230/zelda-therapeutics-in-deal-with-ilera-to-access-us-market-216230.html
<![CDATA[News - Zelda Therapeutics secures patent to detect breast cancer ]]> https://www.proactiveinvestors.com.au/companies/news/215875/zelda-therapeutics-secures-patent-to-detect-breast-cancer-215875.html Zelda Therapeutics Ltd (ASX:ZLD) has been granted a new patent in Australia covering a novel method to predict patient disease-free survival.

The patent details a method for detecting levels of expression of a novel receptor complex containing HER2 and CB2 (types of protein).

HER2 is a well-recognised marker of aggressive breast cancer while CB2 is a key receptor in the endocannabinoid system.

Together they form a novel receptor complex that represents a prognostic marker for HER2 positive breast cancer.

READ: Zelda Therapeutics leveraged to study results that progress cannabis-based cancer therapies

Zelda’s managing director Dr Richard Hopkins said: “We’re delighted with the allowance of this patent, which supports Zelda’s strategy of building a world-class intellectual property portfolio and the development of cannabis-based products.

“Further news is expected as this patent family progresses through the international examination phase.

“I’d also like to acknowledge the work of Professor Cristina Sanchez and her team who generated the data that supported this patent.

“This work was recently published in the prestigious peer-reviewed Proceedings of the National Academy of Sciences.

“This outcome highlights the benefit of Zelda’s approach of partnering with world-leading cannabis researchers.

“Importantly, Professor Sanchez’s discovery of a novel prognostic biomarker, will complement our ongoing efforts develop to cannabis-based medicines to treat breast cancer.”

A vertically integrated medical cannabis strategy

The company’s focus remains on the development of novel cannabinoid-based therapies for a range of diseases.

Zelda is undertaking a human clinical trial program focused on insomnia, autism and opioid reduction with activities in Australia and the US.

Pre-clinical research activities include programs examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

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Wed, 06 Mar 2019 12:20:00 +1100 https://www.proactiveinvestors.com.au/companies/news/215875/zelda-therapeutics-secures-patent-to-detect-breast-cancer-215875.html
<![CDATA[News - Zelda Therapeutics leveraged to study results that progress cannabis-based cancer therapies ]]> https://www.proactiveinvestors.com.au/companies/news/215463/zelda-therapeutics-leveraged-to-study-results-that-progress-cannabis-based-cancer-therapies-215463.html Zelda Therapeutics Ltd (ASX:ZLD) has confirmed that the results of a study undertaken by a member of its medical advisory board have been published in the prestigious Proceedings of the National Academy of Sciences.

The paper titled 'Therapeutic targeting of HER2-CB2R heteromers in HER2-positive breast cancer' was published by Professor Cristina Sanchez and her team based at  Complutense University in Madrid, Spain and describes a mechanism by which cannabinoid receptor CB2 can bind the HER2 receptor to form a novel complex.

The findings identified a new target in the endocannabinoid system for the treatment of HER2+ breast cancer.

Better understanding of endocannabinoid system in cancer

Zelda’s chief executive officer Richard Hopkins said: “This paper makes an important contribution to our understanding of the role of the endocannabinoid system in cancer and has identified a novel therapeutic target for management of HER2+ breast cancer.

“Zelda is delighted to be collaborating with Professor Sanchez and her team.

“This study provides further validation of Zelda’s strategy to partner with the world’s leading researchers and represents an important step towards the development of new cannabis-based therapies for the treatment of cancer.”

READ: Zelda Therapeutics reflects on busy December half

Zelda’s cancer-focused pre-clinical research is designed to build a comprehensive data set and novel intellectual property in a form that can be licensed to third parties in the future.

As part of the agreement with Sanchez and the Complutense University, IP generated from the collaboration will be assigned to Zelda.

This strategy complements the existing clinical trial portfolio to validate formulations and provide robust clinical evidence demanded by the medical community and regulators.

Successful completion of these trials allows the company to quickly move towards commercialisation.

Zelda's product pipeline

READ: Zelda Therapeutics links up with International Cannabis and Cannabinoids Institute

Earlier this month the company engaged the International Cannabis and Cannabinoids Institute (ICCI), an international centre of excellence in the advancement of cannabinoid treatments, to support its clinical trial programs in autism, opioid reduction and insomnia.

Hopkins said at the time: “We’re honoured to be working with the ICCI and Dr Ethan Russo, who are recognised globally as leading authorities on medicinal cannabis, their insights will help inform and accelerate our clinical trial programs.”

Zelda is also in partnership with world-leading researchers and organisations on its pre-clinical research program, examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as examining the potential for cannabinoids to treat diabetes-associated cognitive decline. 

- Jessica Cummins

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Wed, 27 Feb 2019 19:54:00 +1100 https://www.proactiveinvestors.com.au/companies/news/215463/zelda-therapeutics-leveraged-to-study-results-that-progress-cannabis-based-cancer-therapies-215463.html
<![CDATA[News - Zelda Therapeutics reflects on busy December half ]]> https://www.proactiveinvestors.com.au/companies/news/215163/zelda-therapeutics-reflects-on-busy-december-half-215163.html Zelda Therapeutics Ltd (ASX:ZLD) has made significant progress in its strategy to grow its business in the December half of 2018.

The company’s focus remains on the development of novel cannabinoid-based therapies for a range of diseases.

READ: Zelda Therapeutics on track to report on multiple clinical trials

Zelda is undertaking a human clinical trial program focused on insomnia, autism and opioid reduction with activities in Australia and the US.

Pre-clinical research activities include programs examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

Zelda also formed a strategic partnership with European medicinal cannabis group HAPA Medical BV, to access HAPA’s EU-GMP grade manufacturing capabilities and accessing its German distribution network

READ: Zelda Therapeutics links up with International Cannabis and Cannabinoids Institute

Proactive spoke to Zelda’s managing director Dr Richard Hopkins about their vertically integrated strategy in December 2018.

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Mon, 25 Feb 2019 09:22:00 +1100 https://www.proactiveinvestors.com.au/companies/news/215163/zelda-therapeutics-reflects-on-busy-december-half-215163.html
<![CDATA[News - Zelda Therapeutics links up with International Cannabis and Cannabinoids Institute ]]> https://www.proactiveinvestors.com.au/companies/news/214396/zelda-therapeutics-links-up-with-international-cannabis-and-cannabinoids-institute-214396.html Zelda Therapeutics Ltd (ASX:ZLD) has engaged the International Cannabis and Cannabinoids Institute (ICCI) to support its clinical trial programs in autism, opioid reduction and insomnia. 

This provides Zelda with an opportunity to collaborate with a panel of leading international medicinal cannabis experts.

The ICCI is an international centre of excellence for the advancement of cannabis and cannabinoid treatments.

The ICCI provides access to a global network of specialist services including expert advice on clinical study design and execution, requirements for regulatory approval, a full range of contract research services and direct liaison with study investigators.

READ: Zelda Therapeutics on track to report on multiple clinical trials

Zelda’s managing director Dr Richard Hopkins said: “We’re honoured to be working with the ICCI and Dr Ethan Russo, who are recognised globally as leading authorities on medicinal cannabis. Their insights will help inform and accelerate our clinical trial programs.

“Dr Russo and the ICCI will complement our existing medical advisory team and maintains Zelda’s strategy of engaging the world’s best medicinal cannabis researchers and clinicians.”

Dr Ethan Russo was recently appointed the Director of Research and Development at the ICCI.

He is a US-trained board-certified paediatric and adult neurologist, psychopharmacology researcher, former Senior Medical Advisor to GW Pharmaceuticals, and Medical Director of PHYTECS.

Dr Russo said: “I’m delighted to be collaborating with Zelda who is at the forefront of efforts to develop plant-derived cannabis medicines that have the potential to improve quality of life for patients.”

Progressing clinical and pre-clinical activities in 2019

Zelda remains on-track to report on the outcome from its clinical trials for insomnia, autism and opioid reduction by mid-2019.

The company is also continuing to assess opportunities to expand its clinical programs where they align with its strategic objectives.

Finally, Zelda is progressing discussions with third parties aiming at securing agreements to distribute clinically-validated Zelda products globally.

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Tue, 12 Feb 2019 10:55:00 +1100 https://www.proactiveinvestors.com.au/companies/news/214396/zelda-therapeutics-links-up-with-international-cannabis-and-cannabinoids-institute-214396.html
<![CDATA[News - Zelda Therapeutics on track to report on multiple clinical trials ]]> https://www.proactiveinvestors.com.au/companies/news/213657/zelda-therapeutics-on-track-to-report-on-multiple-clinical-trials-213657.html Zelda Therapeutics Ltd (ASX:ZLD) continues to progress its core clinical and pre-clinical activities focused on medicinal cannabis.

Importantly, it has also established the foundations to commercialise its medicinal cannabis products in the event the clinical programs are successful.

Zelda remains on-track to report on the outcome from its clinical trials for insomnia, autism and opioid reduction by mid-2019.

The company is also continuing to assess opportunities to expand its clinical programs where they align with its strategic objectives.

Finally, Zelda is progressing discussions with third parties aiming at securing agreements to distribute clinically-validated Zelda products globally.

READ: Zelda Therapeutics investing in medicinal cannabis oral spray

Zelda closed the December quarter with a cash position of $4.41 million and is forecasting expenditure of $1.4 million (including $980,000 on R&D) in the current March quarter.

The increase in R&D expenditure reflects an expansion to the company’s clinical trial activities and additional costs associated with management of its growing intellectual property portfolio.

Harry Karelis steps back from executive role, remains chairman

Zelda’s chairman Harry Karelis said: “This move marks a key step in Zelda’s strategic plan to position the company for success as it enters into the clinical trial and commercialisation phases of its development.

“With the recent appointment of Dr Richard Hopkins as managing director, along with key additions to our Medical Advisory Board and operational team, the time is right for me to step-back from the executive role, as we intended.

“In my ongoing role as chair, I will continue to work with my colleagues on the Zelda Board and the executive team to ensure we deliver on our key milestones.

“With a number of clinical trials underway and our path to commercialisation well advanced, this promises to be a transformational year for the company.”

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Thu, 31 Jan 2019 10:55:00 +1100 https://www.proactiveinvestors.com.au/companies/news/213657/zelda-therapeutics-on-track-to-report-on-multiple-clinical-trials-213657.html
<![CDATA[News - Zelda Therapeutics investing in medicinal cannabis oral spray ]]> https://www.proactiveinvestors.com.au/companies/news/210616/zelda-therapeutics-investing-in-medicinal-cannabis-oral-spray-210616.html Zelda Therapeutics Ltd (ASX:ZLD) has entered an agreement with SUDA Pharmaceuticals Ltd (ASX:SUD) to develop a medicinal cannabis oral spray.

Under the feasibility and option agreement, SUDA will optimise its OroMist® oro-mucosal spray technology to deliver Zelda’s pharmaceutical-grade cannabis formulations across a 12-month work plan.

If successful, a 24-month option gives Zelda the right to negotiate an exclusive license over SUDA’s OroMist® technology for defined indications.

READ: Zelda Therapeutics partners with St Vincent’s Hospital for opioid reduction study

Zelda’s managing director Dr Richard Hopkins said: “Our aim is to improve upon existing market-approved oral-mucosal formulations that have proven very effective for delivering cannabis medicines in patients.

“This agreement provides Zelda with an option to license a proprietary technology for oral-mucosal delivery of medicinal cannabis. Having access to proprietary technologies strengthens our competitive position and helps accelerate our path to commercialisation.”

SUDA ’s managing director Stephen Carter added: “We are delighted to be working with Zelda on this project. We believe our technology can offer unique advantages compared to other routes of administration for delivering medicinal cannabis.”

Zelda will pay $300,000 up front to SUDA

Zelda will pay SUDA an option fee of $200,000 consisting of an upfront payment of $100,000 and a further $100,000 in downstream milestone payments.

The company will also fund SUDA's pre-agreed project expenditure.

Clinical trials are still at the centre of Zelda's operations

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Thu, 06 Dec 2018 09:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/210616/zelda-therapeutics-investing-in-medicinal-cannabis-oral-spray-210616.html
<![CDATA[Media files - Zelda Therapeutics poised to 'value add all the way from clinical trials to the market' ]]> https://www.proactiveinvestors.com.au/companies/stocktube/11389/zelda-therapeutics-poised-to-value-add-all-the-way-from-clinical-trials-to-the-market--11389.html Mon, 03 Dec 2018 09:30:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/11389/zelda-therapeutics-poised-to-value-add-all-the-way-from-clinical-trials-to-the-market--11389.html <![CDATA[News - Zelda Therapeutics partners with St Vincent’s Hospital for opioid reduction study ]]> https://www.proactiveinvestors.com.au/companies/news/209866/zelda-therapeutics-partners-with-st-vincents-hospital-for-opioid-reduction-study-209866.html Zelda Therapeutics Ltd (ASX:ZLD) (OTCMKTS:ZLDAF) has expanded a human clinical trial program to use cannabinoid medications in patients on chronic, high dose opioid pain management therapy.

This will see Zelda partner with St Vincent’s Hospital in Melbourne in a clinical trial partnership to examine the potential to use certain cannabinoid medications.

The joint clinical trial program is aimed at assisting patients who have become dependent on opioids for chronic pain management.

READ: Zelda Therapeutics to focus on US and Australia clinical trials

Managing director Dr Richard Hopkins said, “Zelda is delighted to work with the team at St Vincent’s, which continues our partnership activities with world-class institutes across the globe.”

Prescription opioids are used to treat chronic pain and these drugs can have serious side effects including physical dependence.

Research shows growing numbers of Australians receiving treatment for dependence on painkillers with the rate of accidental deaths due to opioids doubling for those aged 35 to 44 since 2007.

More than two-thirds of these deaths have been due to pharmaceutical opioids.

Dr Hopkins said: “While similar studies have been conducted in other countries with promising results, we believe that local medical community participation in these studies will accelerate acceptance of the potential of cannabinoid-based medicines.”

The clinical team will be led by Associate Professor Yvonne Bonomo, and includes Dr Jane Trinca, Professor David Castle and Dr Nigel Strauss.

READ: Zelda Therapeutics begins observational trial for medicinal cannabis treatment of autism

An initial pharmacokinetic study will inform a small-scale 20 patient double-blinded, randomised, placebo-controlled study, with the potential to expand into a larger trial depending on results.

Protocols being finalised

Clinical trial protocols are being finalised and are expected to be lodged soon with the human ethics committee for review.

Subject to approvals, the trial would be expected to start in early 2019.

Trial medication will be sourced from Zelda’s strategic partner HAPA Medical for manufacture and supply of pharmaceutical-grade medicinal cannabis.

Should the trial results show benefits, Zelda expects to be able to supply the medicines to Australian patients via specialists registered under the Authorised Prescriber Scheme.

READ: Zelda Therapeutics doses first patient in insomnia clinical trial

Zelda is focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions.

Range of human clinical trials

The company is undertaking human clinical trials focused on insomnia, autism and opioid reduction with activities in Australia and the USA.

It is also undertaking pre-clinical research examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

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Mon, 26 Nov 2018 09:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/209866/zelda-therapeutics-partners-with-st-vincents-hospital-for-opioid-reduction-study-209866.html
<![CDATA[News - Zelda Therapeutics founders commit to not selling their shares ]]> https://www.proactiveinvestors.com.au/companies/news/208679/zelda-therapeutics-founders-commit-to-not-selling-their-shares-208679.html Zelda Therapeutics Ltd (ASX:ZLD) has received a vote of confidence from a group of directors who have committed to not sell their shares and options coming out of escrow for a further 12 months.

The relevant directors - Messrs Karelis, Washer, Peterson and Ms Mara Gordon, collectively known as the Founders, are demonstrating their belief in the company’s future.

The relevant shares and options are being released from their 24-month escrow on 22 November 2018.

The Founders’ voluntary lock-up commitments represent 220.26 million shares and 20 million unlisted options.

READ: Zelda Therapeutics to focus on US and Australia clinical trials

Zelda’s chairman Harry Karelis said: “Since founding the company in 2015, the Founders have worked hard to position Zelda at the forefront of the burgeoning global medicinal cannabis industry.

“We have established a number of collaborations with globally recognised institutions and commenced our clinical trial activities.

“We are excited by the potential for company transformational milestones being achieved over the next year.

“Voluntarily extending our escrow term clearly demonstrates our long-term commitment to the company.”

Founders interests aligned with shareholders

Zelda’s managing director Dr Richard Hopkins added: “By agreeing to a voluntary escrow, the Founding Directors have demonstrated their interests are aligned with all shareholders.

“The Founders are to be commended for their decision, which sends a strong positive signal regarding the longer-term future of the company.”

Dr Hopkins formally commenced as managing director with the Zelda on 16 July 2018.

Preliminary autism trial results are expected in the first half of 2019

In the recent September quarterly report Dr Hopkins said: “We are delighted to have commenced the insomnia and autism trials, which represents a significant landmark for the company.

"This was complemented by the strategic partnership with HAPA, which provides Zelda with access to one of the world’s most significant markets for medicinal cannabis.

"The fact that HAPA are one of the few suppliers in the world who can manufacture to EU-GMP standards provides Zelda with a huge competitive advantage.

"With the results of the clinical trials expected during the first half of 2019, we are now well positioned to continue leveraging our strong strategic position into global markets.”

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Wed, 07 Nov 2018 09:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/208679/zelda-therapeutics-founders-commit-to-not-selling-their-shares-208679.html
<![CDATA[News - Zelda Therapeutics to focus on US and Australia clinical trials ]]> https://www.proactiveinvestors.com.au/companies/news/206837/zelda-therapeutics-to-focus-on-us-and-australia-clinical-trials-206837.html Zelda Therapeutics Ltd (ASX:ZLD) has made a decision following a strategic review to prioritise its clinical trial activities in the US and Australia and cease clinical operations in Chile.

This will ensure Zelda’s resources are focussed on generating clinical data that will best facilitate access to the largest global markets for medicinal cannabis.

Zelda is currently undertaking clinical trials in autism and insomnia in the US and Australia.

READ: Zelda Therapeutics begins observational trial for medicinal cannabis treatment of autism

The Chilean clinical trial collaboration with Fundación Daya has agreed to be ended and also the company’s eczema program will be de-prioritised for now.

Zelda’s managing director Dr Richard Hopkins said: “Following the recent strategic review, the board decided to cease clinical operations in Chile to concentrate on our clinical trial activities in the US and Australia.

“Successful outcomes to clinical studies undertaken in these countries will strengthen our commercialisation position in all major global markets, including Chile.

“Companies evaluating license deals usually put greater weight on US and Australian-based clinical trials so it makes sense to focus on these markets.”

READ: Zelda Therapeutics doses first patient in insomnia clinical trial

Recently, Zelda dosed the first patient in its pioneering medical cannabis insomnia clinical trial.

The company also recently commenced recruitment for its observational trial for autism in the US.

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Thu, 11 Oct 2018 11:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/206837/zelda-therapeutics-to-focus-on-us-and-australia-clinical-trials-206837.html
<![CDATA[News - Zelda Therapeutics begins observational trial for medicinal cannabis treatment of autism ]]> https://www.proactiveinvestors.com.au/companies/news/206728/zelda-therapeutics-begins-observational-trial-for-medicinal-cannabis-treatment-of-autism-206728.html Zelda Therapeutics Ltd (ASX:ZLD) (OTCMKTS:ZLDAF) (FRA:G1G) has started recruitment for an autism observational trial in the USA centred on medicinal cannabis treatment.

Fifteen patients have been formally enrolled and first results are expected in the first half of 2019.

The trial, which is seeking to better understand the efficacy of medicinal cannabis treatment in existing patients, is being carried out at Children’s Hospital of Philadelphia (CHOP) in the USA.

“Diagnosis rates on the rise”

Zelda and CHOP will work closely with patient advocacy groups during the trial.

The company’s managing director Dr Richard Hopkins said, “We are excited to have this study underway and to be working alongside CHOP to conduct one of the first formal, robust studies of its type in the world.

“With studies showing that around one in 100 people have autism and with diagnosis rates on the rise, we’re focused on addressing a major unmet need for potential new therapies to help treat this condition.”

The study will utilise CHOP’s extensive research infrastructure and is designed to capture a number of key efficacy and safety measures, including clinical pharmacological data using a novel micro-sampling technique developed by CHOP.

Pediatric patients already being treated with medicinal cannabis formulations will be monitored.

Possible future clinical trial

It will lay the groundwork for a possible future clinical trial to generate high-quality, robust and acceptable data to validate the existing anecdotal data amongst patient populations.

The ultimate goal is to identify cannabinoid-based compounds that may demonstrate efficacy in the treatment of pediatric autism.

Developing cannabinoid-based formulations

Zelda is an Australian-based bio-pharmaceutical company focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions.

The company has a two-armed strategy comprising:

- A human clinical trial program focused on insomnia and autism with activities in Australia, Chile and the USA.

- A pre-clinical research program examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

READ: Zelda Therapeutics doses first patient in insomnia clinical trial

The company recently dosed the first patient in its medical cannabis insomnia clinical trial with results expected in the first half of 2019.

A randomised, placebo-controlled, crossover study design will be used to treat 24 patients with Zelda’s medicinal cannabis formulation.

The study will collect and analyse data to determine the effect of the formulation on the time it takes to fall asleep, time spent awake and asleep during the night and quality of sleep.

READ: Zelda Therapeutics enters German medical cannabis market with partnership

Another recent development has been a distribution and manufacturing strategic partnership with German medicinal cannabis group HAPA Medical.

Under this arrangement, HAPA has first rights to distribute and/or manufacture Zelda’s clinically validated formulations into the rapidly growing German market.

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Wed, 10 Oct 2018 09:33:00 +1100 https://www.proactiveinvestors.com.au/companies/news/206728/zelda-therapeutics-begins-observational-trial-for-medicinal-cannabis-treatment-of-autism-206728.html
<![CDATA[News - Zelda Therapeutics doses first patient in insomnia clinical trial ]]> https://www.proactiveinvestors.com.au/companies/news/205692/zelda-therapeutics-doses-first-patient-in-insomnia-clinical-trial-205692.html Zelda Therapeutics Ltd (ASX:ZLD) has dosed the first patient in its pioneering medical cannabis insomnia clinical trial.

A randomised, placebo-controlled, crossover study design will be used to treat 24 patients with Zelda’s medicinal cannabis formulation.

The study will collect and analyse data to determine the effect of the Zelda formulation on the time it takes to fall asleep, time spent awake and asleep during the night and quality of sleep.

Results from the trial are expected in the first half of 2019.

READ: Zelda Therapeutics enters German medical cannabis market with partnership

Dr Richard Hopkins, Managing Director of Zelda said, “This is a major milestone for Zelda as it represents the first of a number of clinicaltrials we’re planning to commence over the coming months.

“Positive data will enable Zelda to accelerate its commercialisation plans, which have been facilitated by our recent agreement with HAPA Medical to manufacture and distribute Zelda products in Germany and Europe.”


Bloomberg recently reported that US investors are piling into an exchange-traded fund (ETF) known as ETFMG Alternative Harvest ETF which tracks the Canadian cannabis industry.

This comes as the country moves toward legalisation and liquor producers show growing interest in selling cannabis.

The US-listed US$662 million cannabis ETF is up 20% over the past month.

Alcohol giants teaming up with cannabis companies

Recently, alcohol giant Constellation Brands Inc (NYSE:STZ) invested $3.8 billion in Canadian marijuana maker Canopy Growth Corp (NYSE:CGC).

This is the biggest deal to date in what is now a fast emerging industry and has played a key role in turning investors’ attention to the industry.

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Wed, 26 Sep 2018 09:25:00 +1000 https://www.proactiveinvestors.com.au/companies/news/205692/zelda-therapeutics-doses-first-patient-in-insomnia-clinical-trial-205692.html
<![CDATA[Media files - Zelda enters rapidly-growing German market with product commercialisation strategy ]]> https://www.proactiveinvestors.com.au/companies/stocktube/10409/zelda-enters-rapidly-growing-german-market-with-product-commercialisation-strategy-10409.html Sun, 09 Sep 2018 20:46:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/10409/zelda-enters-rapidly-growing-german-market-with-product-commercialisation-strategy-10409.html <![CDATA[News - Zelda Therapeutics enters German medical cannabis market with partnership ]]> https://www.proactiveinvestors.com.au/companies/news/204079/zelda-therapeutics-enters-german-medical-cannabis-market-with-partnership-204079.html Zelda Therapeutics Ltd (ASX:ZLD) has entered a distribution and manufacturing strategic partnership with German medicinal cannabis group HAPA Medical.

As per the deal, HAPA will have first rights to distribute and/or manufacture Zelda’s clinically validated formulations into the rapidly growing German market. 

READ: Zelda Therapeutics strengthens Scientific and Medical Advisory Board with two appointments

Zelda’s managing director Dr Richard Hopkins said: “This partnership re-enforces the global breadth of Zelda’s relationships and shows our focus on commercialising our clinically validated formulations.

“This is also important because Germany is expected to become the world’s single largest market for medicinal cannabis.”

With a population of 83 million people, Germany is estimated to have the potential to become the world’s largest single medical cannabis market.

HAPA attracted to Zelda’s science-driven approach

HAPA’s managing director Ricardo Pendón said: “We are delighted to be entering this partnership with Zelda which is positioned as one of the world’s leading science-driven medicinal cannabis companies.

“Growth in doctor and patient use is enabled by clinically validated data and having access to Zelda’s pipeline of products is an important success factor for us.”

Zelda remains focused on rapid commercialisation of its products subject to success in clinical trials.

READ: Zelda Therapeutics attracts new managing director, Dr Richard Hopkins

Germany is a very attractive market for Zelda with legislation passed in March 2017 allowing doctors to prescribe cannabis in certain circumstances.

Furthermore, recreational use and self-cultivation are prohibited in Germany.

Cannabis-related medicines potentially reimbursable

Under the German regulatory framework, the cost of cannabis-related medicines is potentially reimbursable for patients that register with their insurer.

The subsidised nature of the medicinal cannabis industry in Germany has catalysed growth in the number of registered patients that has far exceeded initial forecasts.

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Tue, 04 Sep 2018 09:13:00 +1000 https://www.proactiveinvestors.com.au/companies/news/204079/zelda-therapeutics-enters-german-medical-cannabis-market-with-partnership-204079.html
<![CDATA[News - Zelda Therapeutics strengthens Scientific and Medical Advisory Board with two appointments ]]> https://www.proactiveinvestors.com.au/companies/news/203344/zelda-therapeutics-strengthens-scientific-and-medical-advisory-board-with-two-appointments-203344.html Zelda Therapeutics Ltd (ASX:ZLD) (OTCBB:ZLDAF) has added clinical expertise and depth to its Scientific and Medical Advisory Board through the appointment of two medicinal cannabis experts.

Professor David Casarett and Dr Dustin Sulak are internationally recognised as key opinion leaders in the clinical use of medicinal cannabis and are both based in the United States.

READ: Zelda Therapeutics attracts new managing director, Dr Richard Hopkins

The appointments support the development of Zelda’s novel medicinal cannabis therapies for autism, insomnia and cancer.

Zelda’s managing director Dr Richard Hopkins said, “We are delighted Dr Casarett and Dr Sulak have agreed to join our Scientific and Medical Advisory Board.

“They bring extensive expertise in the use of medicinal cannabis that will inform our clinical programs for indications including autism, insomnia and cancer.

“Their ability to access US-based patient groups will also support our strategy to bring Zelda-branded products to market.”

 

Professor Casarett is a leading palliative care physician and researcher at Duke University in North Carolina with a core interest in medicinal cannabis.

Dr Sulak is a high-profile medicinal cannabis practitioner who has treated more than 18,000 patients in the US.

World-class advisory board

Other members of the board are Professor Manuel Guzmán, Dr Cristina Sánchez and Dr Noah Federman.

Professor Guzmán is Full Professor of Biochemistry and Molecular Biology at Madrid’s Complutense University and Dr Sánchez is an Assistant Professor at Complutense University, Madrid, Spain.

Dr Federman is director of the Pediatric Bone and Soft Tissue Sarcoma Program at University of California (Los Angeles), part of the UCLA Sarcoma Program and UCLA’s Jonsson Comprehensive Cancer Centre.

READ: Zelda Therapeutics progresses medicinal cannabis brain cancer research

Zelda is an Australian-based bio-pharmaceutical company focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions.

The company has a two-pronged strategy comprising:

- A human clinical trial program focused on insomnia, autism and eczema with activities in Australia, Chile and the USA.

- A pre-clinical research program examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

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Wed, 22 Aug 2018 08:49:00 +1000 https://www.proactiveinvestors.com.au/companies/news/203344/zelda-therapeutics-strengthens-scientific-and-medical-advisory-board-with-two-appointments-203344.html
<![CDATA[News - Zelda Therapeutics attracts new managing director, Dr Richard Hopkins ]]> https://www.proactiveinvestors.com.au/companies/news/200799/zelda-therapeutics-attracts-new-managing-director-dr-richard-hopkins-200799.html Zelda Therapeutics Ltd (ASX:ZLD) has appointed experienced drug developer Dr Richard Hopkins as its managing director, effective today.

Dr Hopkins brings extensive knowledge and experience with his established track record in drug development of novel cancer therapies.

He also has strong experience with corporate strategy, business development and intellectual property matters.

Strategic focus on clinical validation of medicinal cannabis

Zelda’s new managing director Dr Richard Hopkins said: “I am excited to be joining Zelda Therapeutics at such a key point in the company’s development.

“I look forward to adding value to Zelda’s strategic direction and in particular leveraging revenue opportunities from the current clinical programs in the fast-growing medicinal cannabis sector.”

READ: Zelda Therapeutics progresses medicinal cannabis brain cancer research

Zelda is an Australian-based bio-pharmaceutical company that is focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions.

The company has a two-pronged strategy comprising:

• A human clinical trial programme focused on insomnia, autism and eczema with activities in Australia, Chile and the US; and
• A pre-clinical research program examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.

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Mon, 16 Jul 2018 09:12:00 +1000 https://www.proactiveinvestors.com.au/companies/news/200799/zelda-therapeutics-attracts-new-managing-director-dr-richard-hopkins-200799.html
<![CDATA[Media files - Zelda Therapeutics ready to test 'entourage effect' hypothesis in cancer research ]]> https://www.proactiveinvestors.com.au/companies/stocktube/9606/zelda-therapeutics-ready-to-test-entourage-effect-hypothesis-in-cancer-research-9606.html Mon, 18 Jun 2018 17:23:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/9606/zelda-therapeutics-ready-to-test-entourage-effect-hypothesis-in-cancer-research-9606.html <![CDATA[News - Zelda Therapeutics progresses medicinal cannabis brain cancer research ]]> https://www.proactiveinvestors.com.au/companies/news/198313/zelda-therapeutics-progresses-medicinal-cannabis-brain-cancer-research-198313.html Zelda Therapeutics Ltd (ASX:ZLD) continues to progress its paediatric (children) brain cancer research project with the Telethon Kids Institute in Perth, Western Australia.

The research project is focused on the pre-clinical testing of Zelda’s compounds, formulations and protocols on pediatric medulloblastoma cell lines.

Medulloblastoma is a common brain tumour in children and accounts for about 15% of brain cancers in children.

Cannabinoids are having an anticancer effect

Initial results have shown that increasing doses of pure ∆9 tetrahydrocannabinol (THC) or pure cannabidiol (CBD) reduces cancer cell viability in cell-based assays.

That means the cannabinoids are having an anticancer effect by reducing the proliferation of cancer cells.

Furthermore, high doses of THC and CBD in combination with cyclophosphamide (a type of chemotherapy agent) shows an increase in antiproliferative effect.

Additional studies are planned to further understand the nature of this effect.

READ: Zelda Therapeutics attracts experienced biopharmaceutical managing director

Zelda’s chairman Harry Karelis said: “We are very pleased to show that pure cannabinoids have demonstrated anti-cancer effect in these assays which gives us confidence that our systems are working well.

“We look forward to the results from the next phase of our research which will test the effectiveness of our formulations on these same assays providing rigorous comparative data as well as in in vivo models.”

Next phase testing full plant extracts

The next phase of the research project will be testing Zelda’s full plant extracts in these same assays and hoping to achieve better results than the individual pure cannabinoids.

At the same time, these full plant extracts will be tested in animal models hosting human tumours to determine the extent of any anti-cancer effect in these in vivo models.

These in vivo studies will generate invaluable data on the potential for cannabinoids to play a role in future cancer therapy regimes.

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Wed, 06 Jun 2018 08:33:00 +1000 https://www.proactiveinvestors.com.au/companies/news/198313/zelda-therapeutics-progresses-medicinal-cannabis-brain-cancer-research-198313.html
<![CDATA[News - Zelda Therapeutics attracts experienced biopharmaceutical managing director ]]> https://www.proactiveinvestors.com.au/companies/news/197405/zelda-therapeutics-attracts-experienced-biopharmaceutical-managing-director-197405.html Zelda Therapeutics Ltd (ASX:ZLD) has appointed Dr Richard Hopkins as its managing director commencing 1 July 2018.

Hopkins is an experienced biopharmaceutical executive with over 11 years in corporate leadership roles with public biotechnology companies.

Dr Stewart Washer will step back from his executive position but positively will revert to a non-executive director and remain with the company.

READ: Zelda Therapeutics advancing Australia-first insomnia trial

Zelda’s executive chairman Harry Karelis said: “We have achieved much since our inception in 2015 and have developed deep relationships across the globe and created significant value for our shareholders.

“As the company prepares for its next phase of growth we are very pleased to have been able to attract someone of the calibre of Richard to join the team in a leadership position.

“We are in very capable hands and we will be working closely together to build on our success to date.

“Furthermore, the options incentive package recognises the importance of aligning the interests of management with those of shareholders.”

During Dr Hopkins’ career he has managed and overseen several strategic alliance and licensing deals with multiple global pharmaceutical partners.

He holds a PhD in molecular biology, is an author on over 25 peer-reviewed publications and is an inventor on 17 patents and patent applications.

Most recently, he was the CEO of biotech PharmAust Ltd (ASX:PAA) and he currently serves as chair of the Western Australian Ausbiotech Committee.

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Tue, 22 May 2018 09:16:00 +1000 https://www.proactiveinvestors.com.au/companies/news/197405/zelda-therapeutics-attracts-experienced-biopharmaceutical-managing-director-197405.html
<![CDATA[Media files - Zelda Therapeutics "ahead of the pack" in gaining first-mover advantages ]]> https://www.proactiveinvestors.com.au/companies/stocktube/9208/zelda-therapeutics-ahead-of-the-pack-in-gaining-first-mover-advantages-9208.html Fri, 04 May 2018 18:11:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/9208/zelda-therapeutics-ahead-of-the-pack-in-gaining-first-mover-advantages-9208.html <![CDATA[News - Zelda Therapeutics advancing Australia-first insomnia trial ]]> https://www.proactiveinvestors.com.au/companies/news/195509/zelda-therapeutics-advancing-australia-first-insomnia-trial-195509.html Zelda Therapeutics Ltd (ASX:ZLD) has completed patient recruitment for Australia’s first clinical study of medical cannabis to treat insomnia.

The next phase of the study will commence shortly with patients undergoing baseline sleep measurements before commencing pharmaceutical dosing.

Positive results will mean Zelda will rapidly focus on commercialisation

Zelda’s executive chairman Harry Karelis said: “This is a significant achievement for Zelda and has the potential to introduce a safe, effective and affordable treatment for patients.

“It is no small feat to be progressing a pioneering study of this nature using medicinal cannabis and is a testament to the quality of people involved that we have reached this point in such a rapid time-frame.

“Positive results will mean Zelda will rapidly focus on commercialisation activities in markets where we have existing knowledge, relationships and access to patients.”

READ: Zelda Therapeutics expands research program to include diabetes related cognitive decline

Zelda’s clinical trial will target a sample population of people with characteristic symptoms of chronic insomnia, which include difficulty falling and staying asleep on a long-term basis.

A randomised, placebo-controlled, cross over study design will be used, where patients are selected at random to be treated with Zelda’s medicinal cannabis formulation or a placebo formulation.

The study will be undertaken by the prestigious University of Western Australia (UWA) Centre for Sleep Science (CSS).

Results expected in late 2018

The study will collect and analyse data to determine the effect of the Zelda formulation on the time of onset of sleep, sleep cycle duration and quality of sleep.

In addition, subjective feedback from patients via standard questionnaires will be collected and analysed alongside the analytical data collected.

It is anticipated that preliminary results from this clinical trial will be available in late 2018.

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Mon, 23 Apr 2018 09:20:00 +1000 https://www.proactiveinvestors.com.au/companies/news/195509/zelda-therapeutics-advancing-australia-first-insomnia-trial-195509.html
<![CDATA[News - Zelda Therapeutics expands research program to include diabetes related cognitive decline ]]> https://www.proactiveinvestors.com.au/companies/news/195200/zelda-therapeutics-expands-research-program-to-include-diabetes-related-cognitive-decline-195200.html Zelda Therapeutics Ltd (ASX:ZLD) has expanded its pre-clinical research program with Curtin Health Innovation Research Institute, which is part of Curtin University.

The company’s research will now include diabetes-related cognitive decline.

There will be a focus on studying the effect of a cannabinoid-based therapeutic moderating the effects of cerebral capillary damage associated with diabetes.

Executive chairman Harry Karelis said: “This study has potential to demonstrate that daily dosing of certain cannabinoids can provide some type of long-term benefit to diabetes sufferers and moderate the effect of capillary damage – at least in validated animal models.”

Links with other conditions such as dementia

Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces.

This can lead to a number of complications including damage to blood vessels in the brain, associated with cognitive decline that can lead to dementia and other conditions.

Globally in 2017, 50 million people suffered from dementia alone, and the risk of developing dementia for people with diabetes is 2.77-fold greater than the healthy population.

Research study could lead to commercialisation

Zelda’s research study will occur in validated animal models of diabetic cognitive decline developed by Curtin University and led by Associate Professor Ryu Takechi.

The study will occur over the next 12-18 months and positive results would allow Zelda to consider commercialisation opportunities of cannabinoid-based medicines.

Karelis said: “The market for cannabis-based therapeutics and wellness products is growing very rapidly.

“Positive results in this study will open up a significant market opportunity for Zelda.”

From a marketing perspective, Zelda will focus on jurisdictions where there is a clear pathway to market and access to distribution partners.

Dementia market valued at US$1 trillion

Diabetes-associated cognitive decline is a rapidly growing market, with the number of dementia sufferers expected to almost double every 20 years, reaching 75 million in 2030.

In 2018, the global cost of dementia is expected to rise above US$1 trillion.

As such, any treatment option shown to provide some form of protective benefit is likely to be a significant relief for potential suffers and a global economic benefit.

READ: Zelda Therapeutics receives approval for US autism study

This development comes less than a week after the company received approval from the Institutional Review Board for its autism project to be conducted at the Children’s Hospital of Philadelphia (CHOP) in the US.

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Wed, 18 Apr 2018 09:06:00 +1000 https://www.proactiveinvestors.com.au/companies/news/195200/zelda-therapeutics-expands-research-program-to-include-diabetes-related-cognitive-decline-195200.html
<![CDATA[News - Zelda Therapeutics receives approval for US autism study ]]> https://www.proactiveinvestors.com.au/companies/news/194897/zelda-therapeutics-receives-approval-for-us-autism-study-194897.html Zelda Therapeutics Ltd (ASX:ZLD) has received Institutional Review Board (IRB) approval for its autism project, to be conducted at the Children’s Hospital of Philadelphia (CHOP) in the US.

The study will monitor child patients already being treated with medicinal cannabis formulations.

This initial study will lay the groundwork for a possible future clinical trial.

READ: Zelda Therapeutics and Children's Hospital of Philadelphia to study the pharmacology of cannabinoids

Zelda’s executive chairman Harry Karelis said “We are very excited to be formally commencing this study in the US working alongside CHOP.

“The high calibre of CHOP researchers and clinicians coupled with access to extensive infrastructure positions this study to be one of the first formal, robust studies of its type conducted to date.

“Positive results will allow Zelda to potentially expand into a formal clinical trial to study the efficacy of standardised, high-quality medicines.

“This study is being conducted in parallel with our pending clinical trial in Chile leveraging the observational data generated in 2017.”

Results expected within six months

This study will utilise CHOP’s extensive research infrastructure.

It will also capture a number of key efficacy and safety measures including bioanalytical studies.

The ultimate goal is to identify cannabinoid-based compounds that may demonstrate efficacy in the treatment of paediatric autism.

Preliminary results expected within six months.

READ: Zelda Therapeutics expands pancreatic cancer research with Curtin University

In early March, Zelda outlined that it would expand its research program with Curtin University testing cannabinoid extracts to potentially treat pancreatic cancer.

New research activities were to investigate the effect of a range of Zelda’s formulations with a focus on animals.

Results from these studies are expected to generate highly relevant data for potential future human clinical trials.

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Fri, 13 Apr 2018 10:32:00 +1000 https://www.proactiveinvestors.com.au/companies/news/194897/zelda-therapeutics-receives-approval-for-us-autism-study-194897.html
<![CDATA[News - Zelda Therapeutics expands pancreatic cancer research with Curtin University ]]> https://www.proactiveinvestors.com.au/companies/news/192631/zelda-therapeutics-expands-pancreatic-cancer-research-with-curtin-university-192631.html Zelda Therapeutics Ltd (ASX:ZLD) will expand its research program with Curtin University testing cannabinoid extracts to potentially treat pancreatic cancer.

New research activities will investigate the effect of a range of Zelda’s formulations with a focus on animals.

Results from these studies are expected to generate highly relevant data for potential future human clinical trials.

Evidence growing that cannabinoid extract can fight cancer

There is a growing body of evidence that whole plant cannabinoid extracts can impede cancer growth.

READ: Zelda Therapeutics well-funded to advance cannabinoid treatments for medical conditions

Harry Karelis, executive chairman, said: “We are very excited to be able to expand the existing collaboration with Professor Marco Falasca’s team at Curtin University.

“The data to be generated by this new program has the potential to open new avenues of treatment for a cancer with very low survival rates.

“We look forward to results being generated over coming months and progressing the body of knowledge in this important field.”

Pancreatic cancer has a very low survival rate

Pancreatic cancer is the twelfth most common cancer globally, with over 330,000 diagnoses in 2012.

Should Zelda yield successful results from this research program, there is a valuable global market Zelda can tap into.

With a very low five-year survival rate, the pancreatic cancer market will greatly benefit from further research and development using novel approaches.

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Tue, 06 Mar 2018 08:50:00 +1100 https://www.proactiveinvestors.com.au/companies/news/192631/zelda-therapeutics-expands-pancreatic-cancer-research-with-curtin-university-192631.html
<![CDATA[News - Zelda Therapeutics well-funded to advance cannabinoid treatments for medical conditions ]]> https://www.proactiveinvestors.com.au/companies/news/192312/zelda-therapeutics-well-funded-to-advance-cannabinoid-treatments-for-medical-conditions-192312.html Zelda Therapeutics Ltd (ASX:ZLD) (OTCQB:ZLDAF) is well funded to make strong progress in 2018 with the development of cannabinoid-based formulations for the treatment of a variety of medical conditions.

The company’s cash at bank was $6.61 million at 31 December 2017 and it is fully funded for its near-term initiatives.

Zelda’s performance in the second half of 2017 has supported strengthening share prices with the company reaching a 5-year high of $0.16 in mid-February.

It is trading in the range of $0.14 and is up more than four times its 12-month low of a year ago.

WATCH NOW: Zelda Therapeutics' Dr Stewart Washer presents at Proactive's CEO Sessions

Harry Karelis, executive chairman, said: “We continue to push ahead with our clinical trial activities which in some cases have never been done before at the level of rigour we are applying.

“This investment in planning will result in very strong and reliable data that can be used to push forward into the next stage of commercialisation activities.

“Our intellectual property portfolio continues to grow from our pre-clinical cancer research activities and we look forward to reporting results in coming months.

“It is a very exciting time for the company as we move into our clinical trial phase.

“Much has been achieved since our inception and 2018 is poised to be a pivotal year in the company’s development.”

Net loss during half year is 90% down

During the half-year ending 31 December 2017, the company reported a net loss after tax of $496,648, down 90% on the corresponding period of 2016.

Zelda is expecting a strong flow of news during 2018 to follow the strong half year performance.

Pre-clinical research targets breast cancer

The company’s pre-clinical cancer research in Spain targeting breast cancer is progressing and generating additional data.

Zelda continues to progress its active intellectual property strategy built around this data.

In Australia, a pre-clinical research program in the area of brain cancer at the Telethon Kids Institute and pancreatic cancer at Curtin University is underway.

This has been made possible by the approval of cannabinoid material for import into Australia.

READ: Zelda Therapeutics approved for Australia’s first medicinal cannabis trial targeting insomnia

Zelda has received full regulatory approval for an insomnia clinical trial, which is expected to start during the first quarter of 2018.

It is the first of its kind in Australia to gain approval from the Human Research Ethics Committee and the Therapeutic Goods Administration, to investigate the effects of medicinal cannabis on chronic insomnia patients.

Preliminary results are anticipated by the third quarter of 2018 and if positive will progress to commercialisation activities for the formulation in various jurisdictions.

Population-based data show that about one-third of adults have regular difficulty getting to sleep or staying asleep.

READ: Zelda Therapeutics and Children's Hospital of Philadelphia to study the pharmacology of cannabinoids

Zelda has also entered into a research agreement with the Children’s Hospital of Philadelphia in the U.S. to study the pharmacology of cannabinoids in the treatment of pediatric patients.

This is an important study and potentially a key milestone in ongoing medicinal cannabis research in a clinical environment.

Trial protocols are being progressed in the company’s Chile autism clinical trial with a view to lodging these with the approving bodies in the coming quarter.

The trials are expected to start later this year.

READ: Zelda Therapeutics' US listing provides access to broader research and capital networks

Zelda recently gained approval for its shares to trade on the OTCQB Venture Market in the United States under the symbol ZLDAF.

This listing provides a new source of demand for the cannabinoid-based formulations developer’s shares from the U.S., the world’s largest market.

The OTCQB is a trading platform operated by OTC Markets Group in New York, and is home to early-stage and developing U.S. and international companies.

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Wed, 28 Feb 2018 13:14:00 +1100 https://www.proactiveinvestors.com.au/companies/news/192312/zelda-therapeutics-well-funded-to-advance-cannabinoid-treatments-for-medical-conditions-192312.html
<![CDATA[News - Zelda Therapeutics' US listing provides access to broader research and capital networks ]]> https://www.proactiveinvestors.com.au/companies/news/190332/zelda-therapeutics-us-listing-provides-access-to-broader-research-and-capital-networks-190332.html Zelda Therapeutics Ltd’s (ASX:ZLD) (OTCQB:ZLDAF) shares have been approved for trading on the OTCQB Venture Market (OTCQB) in the United States under the symbol ZLDAF.

The dual listing structure is non-dilutive for existing Zelda shareholders in that no capital is being raised and no new shares are being issued.

This listing provides a new source of demand for the cannabinoid-based formulations developer’s shares from the US, the world’s largest market.

Opportunity to be recognised as early stage international company

The OTCQB is a US-based trading platform operated by OTC Markets Group in New York, and home to early-stage and developing US and international companies.

To be eligible companies must be current in their financial reporting, pass a minimum $0.01 bid price test and undergo an annual company verification and management certification process.

The OTCQB quality standards provide a strong baseline of transparency, improving the information and trading experience for US-based investors.

Improved access to research and broader capital networks

Through trading on OTCQB, companies can engage a far greater network of US investor, data distributors and media partners.

Harry Kareliss, chairman, said: “We are pleased to announce our new trading relationship with OTCQB.

“As part of our ongoing strategy to introduce Zelda Therapeutics to a broader international audience, this milestone will provide greater visibility, better access to the US investment community, and improved convenience of trading in Zelda’s ordinary shares.”

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Mon, 22 Jan 2018 09:11:00 +1100 https://www.proactiveinvestors.com.au/companies/news/190332/zelda-therapeutics-us-listing-provides-access-to-broader-research-and-capital-networks-190332.html
<![CDATA[News - Zelda Therapeutics and Children's Hospital of Philadelphia to study the pharmacology of cannabinoids ]]> https://www.proactiveinvestors.com.au/companies/news/188549/zelda-therapeutics-and-children-s-hospital-of-philadelphia-to-study-the-pharmacology-of-cannabinoids-188549.html Zelda Therapeutics Ltd (ASX:ZLD) has entered into a research agreement with Children’s Hospital of Philadelphia (CHOP) relating to the pharmacology of cannabinoids.

The ultimate goal is to describe cannabinoid disposition in pediatric patients, and identify compounds that may demonstrate efficacy in the treatment of pediatric autism.

This news was well received with the company’s shares trading as high as $0.10 in mid-morning trading, up nearly 10% from Friday’s close of $0.091.

This builds on recent share price strength which was partly driven by the company being approved for Australia’s first medical cannabis trial for insomnia.

Read: Zelda Therapeutics approved for Australia’s first medicinal cannabis trial targeting insomnia

The collaborative research with CHOP will focus on autism with an observational trial to better understand the efficacy of treatment in existing patients.

The collaborative group will also be working closely with patient advocacy bodies and licensed growers.

This study will leverage CHOP’s extensive research infrastructure and is designed to capture a number of key efficacy and safety measures including bioanalytical studies.

Study to provide a platform for possible future clinical trials

Participating in this study could lay the foundations for a possible future clinical trial to generate high quality, robust and acceptable data.

The information should then be used to assist in validating the extensive positive anecdotal data amongst patient populations.

Preliminary results expected within six months

This collaboration effectively lifts Zelda’s profile as it will be an important U.S.-based study, focusing on the use of cannabinoids in controlled clinical settings.

The observational study is expected to commence in early 2018, with preliminary results anticipated within six months. 

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Mon, 11 Dec 2017 12:39:00 +1100 https://www.proactiveinvestors.com.au/companies/news/188549/zelda-therapeutics-and-children-s-hospital-of-philadelphia-to-study-the-pharmacology-of-cannabinoids-188549.html
<![CDATA[News - Zelda Therapeutics enters medical cannabis research partnership ]]> https://www.proactiveinvestors.com.au/companies/news/188478/zelda-therapeutics-enters-medical-cannabis-research-partnership-188478.html Zelda Therapeutics Ltd (ASX:ZLD) continues to advance its medical cannabis strategy, and the company entered a trading halt this morning pending details of a partnership with a US-based research institution.

READ: Zelda approved for Australia’s first medicinal cannabis trial targeting insomnia

The halt will remain in place until the opening of trade on Tuesday 12th December 2017, or earlier if an announcement is made to the market.

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Fri, 08 Dec 2017 09:23:00 +1100 https://www.proactiveinvestors.com.au/companies/news/188478/zelda-therapeutics-enters-medical-cannabis-research-partnership-188478.html
<![CDATA[News - Zelda Therapeutics approved for Australia’s first medicinal cannabis trial targeting insomnia ]]> https://www.proactiveinvestors.com.au/companies/news/187935/zelda-therapeutics-approved-for-australias-first-medicinal-cannabis-trial-targeting-insomnia-187935.html Zelda Therapeutics Ltd's (ASX:ZLD) shares have bounded 13% higher to $0.13 in early trade following the company being approved for Australia’s first medicinal cannabis trial for insomnia.

The clinical trial approval was granted from the Therapeutics Goods Administration and the Human Research Ethics Committee.

The trial will be undertaken by the prestigious University of Western Australia (UWA) Centre for Sleep Science (CSS), which has state of the art research facilities and is directed by Professor Peter Eastwood, National Health and Medical Research Council Senior Research Fellow.

Zelda’s clinical trial will target a sample population of people with characteristic symptoms of chronic insomnia, which include difficulty falling and staying asleep on a long-term basis.

A randomised, placebo controlled, cross over study design will be used, where patients are selected at random to be treated with Zelda’s medicinal cannabis formulation or a placebo formulation.

Harry Karelis, executive chairman for Zelda, commented: "This is a very exciting milestone for Zelda.

"We have been meticulously working our way through the regulatory framework to ensure we achieve all necessary approvals.

"This has been a very rigorous process and has taken some time but we are now very well positioned and are the first to undertake a clinical trial of this nature in Australia.

"We are very pleased to have partnered with the leading researchers in this field at the prestigious UWA Centre for Sleep Science, and are confident this clinical trial will deliver the high-quality data we need to further develop and commercialise our medicinal cannabis formulation."

WATCH: Zelda's Stewart Washer discussed medical cannabis trials with investors at Proactive's CEO Sessions

The company has been focused on targeting its medicinal cannabis formulations to treat a number of disease conditions, and progress its research to clinical trials, the first being chronic insomnia.

Professor Peter Eastwood, director, centre for sleep science, added:

"Australia has been a leader in sleep medicine for many years and our Western Australia based Centre comes equipped with state-of-the-art sleep recording and analysis equipment.

"For this trial we have assembled a team of experts including sleep physiologists, sleep physicians and clinical psychologists."

Patient data

Zelda has access to patient data in the U.S. and Chile, which shows anecdotal evidence of benefit from medicinal cannabis when used to treat insomnia.

Based on this data and other studies on the safety of medicinal cannabis, the company has worked with the research team at UWA to develop a rigorous research trial protocol to study the clinical efficacy of its insomnia formulations.

Analysis

It is anticipated that the clinical trial will formally commence in the first quarter of 2018, with patient recruitment expected to commence shortly.

Clinical trials are a key research tool for advancing medical knowledge and patient care.

Population-based data show that about one third of adults have regular difficulty getting to sleep or staying asleep.

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Wed, 29 Nov 2017 10:17:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187935/zelda-therapeutics-approved-for-australias-first-medicinal-cannabis-trial-targeting-insomnia-187935.html
<![CDATA[News - Zelda Therapeutics' soaring shares attract ASX speeding ticket ]]> https://www.proactiveinvestors.com.au/companies/news/187550/zelda-therapeutics-soaring-shares-attract-asx-speeding-ticket-187550.html Zelda Therapeutics Ltd's (ASX:ZLD) shares are currently in pre-open following the ASX granting the company a trading halt.

Zelda requested the halt pending a response to an ASX price query.

The stock had jumped 24% intra-day to $0.11 before the halt was called.

WATCH NOW: Zelda Therapeutics' Dr Stewart Washer presents at Proactive's CEO Sessions

The halt will remain in place until the opening of trade on Thursday 23rd November 2017, or earlier if an announcement is made to the market.

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Tue, 21 Nov 2017 15:33:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187550/zelda-therapeutics-soaring-shares-attract-asx-speeding-ticket-187550.html
<![CDATA[News - Zelda's Stewart Washer discussed medical cannabis trials with investors at Proactive's CEO Sessions ]]> https://www.proactiveinvestors.com.au/companies/news/187188/zelda-s-stewart-washer-discussed-medical-cannabis-trials-with-investors-at-proactive-s-ceo-sessions-187188.html Zelda Therapeutics Ltd's (ASX:ZLD) executive director, Stewart Washer, joined Proactive's CEO Sessions in Melbourne and Sydney this week.

Zelda is developing a range of cannabinoid-based formulations to treat medical conditions.

WATCH NOW: Zelda Therapeutics' Dr Stewart Washer presents at Proactive's CEO Sessions ACCESS THE FULL PRESENTATION HERE ]]>
Fri, 17 Nov 2017 11:23:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187188/zelda-s-stewart-washer-discussed-medical-cannabis-trials-with-investors-at-proactive-s-ceo-sessions-187188.html
<![CDATA[News - Zelda Therapeutics' shares released from escrow ]]> https://www.proactiveinvestors.com.au/companies/news/187405/zelda-therapeutics-shares-released-from-escrow-187405.html Zelda Therapeutics Ltd (ASX:ZLD) now has an additional 111.6 million shares available for trade on the ASX, following the end of an escrow period.

Zelda now has 530 million shares on issue.

The company is developing a range of cannabinoid-based formulations to treat medical conditions, and Dr. Stewart Washer, executive director, recently presented the next steps to investors.

WATCH NOW: Zelda Therapeutics' Dr Stewart Washer presents at Proactive's CEO Sessions ]]>
Fri, 17 Nov 2017 10:41:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187405/zelda-therapeutics-shares-released-from-escrow-187405.html
<![CDATA[Media files - Zelda Therapeutics' Dr Stewart Washer presents at Proactive's CEO Sessions ]]> https://www.proactiveinvestors.com.au/companies/stocktube/8368/zelda-therapeutics-dr-stewart-washer-presents-at-proactive-s-ceo-sessions-8368.html Wed, 15 Nov 2017 08:30:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/8368/zelda-therapeutics-dr-stewart-washer-presents-at-proactive-s-ceo-sessions-8368.html <![CDATA[Media files - Zelda Therapeutics closing in on development of autism clinical trial ]]> https://www.proactiveinvestors.com.au/companies/stocktube/8303/zelda-therapeutics-closing-in-on-development-of-autism-clinical-trial-8303.html Mon, 30 Oct 2017 09:41:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/8303/zelda-therapeutics-closing-in-on-development-of-autism-clinical-trial-8303.html <![CDATA[News - Zelda Therapeutics brings medical cannabis trials to Proactive's CEO Sessions ]]> https://www.proactiveinvestors.com.au/companies/news/186138/zelda-therapeutics-brings-medical-cannabis-trials-to-proactive-s-ceo-sessions-186138.html Zelda Therapeutics Ltd (ASX:ZLD) is developing a range of cannabinoid-based formulations to treat medical conditions, and recently sponsored an observation autism trial in Chile.

The trial demonstrated successful results for treating the core symptoms of autism with medicinal cannabis extracts that Zelda is planning on taking into clinical trials.

Results showed that in a cohort of 21 patients, cannabis extracts were significantly more effective than conventional medicines used, including atypical antipsychotics, and these extracts were well tolerated by the patients overall.

Find out more from Dr. Stewart Washer at Proactive's CEO Sessions.

Click below to register by email

- Melbourne: Tuesday 14th November.
- Sydney: Wednesday 15th November.
- Email Pauline here.
- Call office on (02) 9280 0700.

Presenter list

- Zelda Therapeutics (ASX:ZLD): Dr. Stewart Washer
- Thred Ltd (ASX:THD): Geoff Marshall
- De Grey Mining (ASX:DEG): Simon Lill
- Peninsula Energy (ASX:PEN): David Coyle
- Aspire Mining (ASX:AKM): David Paull

 

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Fri, 27 Oct 2017 08:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/186138/zelda-therapeutics-brings-medical-cannabis-trials-to-proactive-s-ceo-sessions-186138.html
<![CDATA[News - Zelda Therapeutics demonstrates successful results treating autism with medicinal cannabis ]]> https://www.proactiveinvestors.com.au/companies/news/184098/zelda-therapeutics-demonstrates-successful-results-treating-autism-with-medicinal-cannabis-184098.html Zelda Therapeutics Ltd (ASX:ZLD) has sponsored an observation autism trial in Chile, demonstrating successful results for treating the core symptoms of autism with medicinal cannabis extracts that Zelda is planning on taking into clinical trials.

The results demonstrated that in a cohort of 21 patients (median age of 9 years 10 months), cannabis extracts were significantly more effective than conventional medicines used, including atypical antipsychotics, and these extracts were well tolerated by the patients overall.

Harry Karelis, executive chairman for Zelda, commented:

"The results from this observational study are very exciting and supports the anecdotal evidence we have, showing the positive effect medicinal cannabis has on treating autism symptoms.

"Zelda will use this baseline data to design its clinical trials and generate rigorous scientific data that validates the clinical benefit of medicinal cannabis.

"We hope that in the near future Zelda Therapeutics can provide an alternative treatment for sufferers of this condition which is of major global significance."

Details of the study

Patients in the study were treated over at least a 12-week period and were examined by electroencephalogram (EEG), neuropsychological analysis as well as metabolism and genetic tests.

The patients in the study had not responded well to conventional treatments.

Patients treated with cannabis extracts demonstrated significant improvements in at least one core symptom including social interaction, language or repetitive behaviours in 71.4% of cases and 66.7% of treated patients showing significant general overall improvement. 

The trial was managed by leading clinician Dr Gisela Kuester who is a highly regarded neurologist specialising in the diagnosis and treatment of autism.

She also holds the position of Clinical Research Director at Fundación Daya.

Strategic alliance

Zelda has previously outlined its strategic alliance with Chilean non-profit patient advocate group Fundación Daya, to leverage their patient data on using cannabinoid-based therapy to treat autism patients.

The results from this observation trial will assist Zelda in the development of its autism clinical trial.

A submission for ethics approval is being finalized and is expected to be submitted in coming weeks.

Zelda expects the trial will commence within three months of regulatory approvals being obtained and will be conducted over a six to nine-month period.

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Mon, 18 Sep 2017 09:48:00 +1000 https://www.proactiveinvestors.com.au/companies/news/184098/zelda-therapeutics-demonstrates-successful-results-treating-autism-with-medicinal-cannabis-184098.html
<![CDATA[News - Zelda Therapeutics making strides in medical cannabis research ]]> https://www.proactiveinvestors.com.au/companies/news/183867/zelda-therapeutics-making-strides-in-medical-cannabis-research-183867.html Zelda Therapeutics Ltd (ASX:ZLD) is making significant progress with its medical cannabis research program in Chile.

The company has already established a focus on autism, eczema and insomnia.

Zelda has now engaged the services of an experienced team of clinicians and scientists to help manage its clinical trials.

Harry Karelis, executive chairman, commented:

"We welcome Dr Kuester, Dr Sasso and Ms Vergara to our research team and are delighted to have such a high calibre local team coordinating our activities in Chile.

"Zelda is steadily progressing towards commencement of its clinical trial program in Chile and I look forward to providing shareholders positive updates in due course."

Why Chile

Zelda has strategically focused on conducting its research activities in Chile due to the efficiency of its legal and regulatory framework, cost effectiveness and its market access into the large South American pharmaceutical market.

The Chilean government granted permission for the first cannabis crop to be planted for medicinal purposes in 2015, and has subsequently allowed the sale of medicinal cannabis in pharmacies.

This has given rise to researchers and organisations specialising in medicinal cannabis treatments.

Zelda has capitalised on this, forming strategic alliances with world-class researchers and physicians, and has access to valuable patient data which will assist in the development of robust clinical trials.

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Wed, 13 Sep 2017 08:58:00 +1000 https://www.proactiveinvestors.com.au/companies/news/183867/zelda-therapeutics-making-strides-in-medical-cannabis-research-183867.html
<![CDATA[News - Zelda shareholders granted priority on float of CannPal Animal Therapeutics ]]> https://www.proactiveinvestors.com.au/companies/news/183056/zelda-shareholders-granted-priority-on-float-of-cannpal-animal-therapeutics-183056.html Zelda Therapeutics Ltd (ASX:ZLD) has a strategic collaborative partnership with CannPal Animal Therapeutics, which is in the process of listing on the ASX.

The companies are looking to exploit opportunities of mutual interest in both the human and animal pharmaceutical markets through the sharing of research data compiled by each of the parties.

CannPal is looking to strengthen the ties between the companies by inviting Zelda shareholders to participate as a priority applicant in the prospectus capital raising lodged with ASIC.

The prospectus is to raise $6 million.

Prospectus and offer details

Under the prospectus, 5 million shares at $0.20 have been allocated and made available to Zelda shareholders registered on the 1st September 2017 holding a minimum of 25,000 shares.

The minimum subscription in CannPal is 10,000 shares worth $2,000.

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Tue, 29 Aug 2017 11:23:00 +1000 https://www.proactiveinvestors.com.au/companies/news/183056/zelda-shareholders-granted-priority-on-float-of-cannpal-animal-therapeutics-183056.html
<![CDATA[News - Zelda Therapeutics' Dr. Stewart Washer discusses medical cannabis achievements ]]> https://www.proactiveinvestors.com.au/companies/news/183050/zelda-therapeutics-dr-stewart-washer-discusses-medical-cannabis-achievements-183050.html Zelda Therapeutics Ltd (ASX: ZLD) has secured exclusive, global access to an extensive set of human data related to medicinal cannabis based formulations and treatment protocols.

This human data has been generated over several years by a California-based group (Aunt Zelda’s) that has a high profile within the U.S. which is also growing internationally.

The company has a deep knowledge of the scientific rationale for certain cannabis-based formulations and protocols to treat a variety of medical conditions.

Zelda has embarked on a program of human clinical trials.

WATCH NOW: Zelda half-year review by Stewart Washer, executive director

Zelda is scheduled to release its financial statements to the ASX on Wednesday 30 August 2017.

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Tue, 29 Aug 2017 09:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/183050/zelda-therapeutics-dr-stewart-washer-discusses-medical-cannabis-achievements-183050.html
<![CDATA[News - Zelda Therapeutics expands breast cancer research ]]> https://www.proactiveinvestors.com.au/companies/news/181672/zelda-therapeutics-expands-breast-cancer-research-181672.html Zelda Therapeutics (ASX:ZLD) has expanded its research collaboration with Complutense University, based on positive initial research results from its breast cancer research program.

The program builds on positive results from its initial proof of concept study from 2016 and follow-on studies in 2017 on its pre-clinical research on cannabinoids as anti-cancer agents.

Results showed a number of key findings, but most importantly that there were anti-cancer effects observed across a range of different breast cancer cell lines using Zelda’s formulations.

Harry Karelis, chairman, commented: “We are delighted to be in a position to expand our research collaboration with Complutense University, who have already generated exciting results using Zelda formulations on breast cancers.

“Expanding our research to gain a deeper understanding of the impact of cannabinoids on tumour re-occurrence is a critical area of research to be able to develop effective anti-cancer therapies in future.”

Expansion of research program

The expansion and extension of Zelda’s current research program with Complutense University will investigate the effect of cannabinoids on cancer stem cell-like cells.

These cells are cancer cells found within tumours that are self-renewing, causing tumour re-growths.

Tumour reoccurrence is a common concern for women following treatment of breast cancer.

The majority of current anticancer therapies are primarily focused on trying to inhibit cancer cell growth, causing cancer cells to die, or a combination of both.

However, even if initial treatments appear successful, some tumours can reoccur at a later date.

The role that cannabinoids can play

Understanding how tumours re-occur and what controls the ability of cancer cells to spread throughout the body, is a crucial aspect of cancer research.

Furthermore, investigating the impacts that cannabinoids could have on cancer stem-cell like cells could provide much needed data in this area of research, and most importantly lead to new treatment regimes for highly resistant tumours.

How this fits into the bigger picture

With positive data already at hand and expansion into further research areas, Zelda continues to make progress on its preclinical activities, in-line with its strategic plan.

Zelda is focused on developing high-quality data packs and an intellectual property portfolio expected to be of great interest to the biopharmaceutical industry and potential future partnering deals.

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Mon, 31 Jul 2017 14:09:00 +1000 https://www.proactiveinvestors.com.au/companies/news/181672/zelda-therapeutics-expands-breast-cancer-research-181672.html
<![CDATA[News - Zelda Therapeutics enters manufacturing and distribution agreement ]]> https://www.proactiveinvestors.com.au/companies/news/179273/zelda-therapeutics-enters-manufacturing-and-distribution-agreement-179273.html Zelda Therapeutics (ASX:ZLD) has entered into a strategic manufacturing and distribution agreement with leading Chilean pharmaceutical manufacturing group, Knop Laboratorios SA.

The agreement locks in a high-quality supply of Zelda’s formulated medicinal-cannabis medicines initially, for its planned clinical trials, and subsequently a secure, scalable and GMP-grade source of commercial quantities following product registration.

Furthermore, Knop operates a chain of pharmacies throughout Chile and the agreement contemplates Knop becoming a key distribution channel in the future for Zelda.

Harry Karelis, chairman, commented: “We are delighted to be entering into this partnership with Knop who have an impressive history in Chile and extensive relationships with key regulators.

“They operate a world-class facility with a newly commissioned ethanol-extraction facility dedicated to producing high-quality cannabis-derived extracts.“


Knop Laboratories

Knop Laboratories are recognised as a signature trusted brand in Chile, dating back to the 1920s.

Knop’s related companies include a pharmacy chain which spans across Chile.

This organisational structure makes Knop an ideal partner for the manufacture of Zelda’s products, providing access to a large distribution network to fast track market penetration in South America.

Zelda has chosen to expand its research programme into Chile because the country’s legal framework recognises the importance of medical cannabis, allowing its production under strict regulatory controls for the treatment of medical conditions.

The country also provides a cost-effective location for Zelda to conduct clinical trials.


Background

Zelda is bio-pharmaceutical company focused on a series of clinical and pre-clinical programs utilising cannabinoid-based medicines.

Zelda has secured exclusive, global access to an extensive set of human data related to medicinal cannabis based formulations and treatment protocols.

This human data has been generated over several years by a California-based group that has a high profile within the U.S. and a growing international profile.

Zelda has embarked on a program of human clinical trials initially in sleep disorder (insomnia), autism and eczema indications.

In addition, Zelda is building a pre-clinical research portfolio targeting cancer.

 

Analysis

The partnership provides a solid platform to expand the company’s activities including its focus on rapid commercialisation.

It will allow Zelda to expedite the clinical trial process, with the certainty of product supply.

Furthermore, it will potentially allow the mass production of Zelda’s medicines for the treatment of eczema, insomnia and autism, providing a natural alternative to many patients who suffer from these conditions.

Knop sees the rapidly growing medicinal cannabis market as a key opportunity and the partnership as a pathway to global opportunities.

Knop believes that Australia and Chile are both well placed to secure leading positions in the global medicinal cannabis market and help fast-track high quality, affordable medicines to patients in need.

Zelda shares have more than doubled in 2017, currently priced at $0.083.

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Thu, 15 Jun 2017 10:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/179273/zelda-therapeutics-enters-manufacturing-and-distribution-agreement-179273.html