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NanoViricides reports stronger cash position; sufficient for first clinical trials

Thu, 23 May 2013 01:53:00 +1000

NanoViricides (OTCBB:NNVC), a development stage company creating special purpose nanomaterials for antiviral therapy, said Wednesday its cash position at the end of the first quarter was "sufficient to carry out its initial clinical trials of its first drug candidate."

Current assets, including cash, cash equivalents, collateral advance, and prepaid expenses, rose to $16.9 million as of March 31, from $14.6 million as of December 31, the West Haven, Connecticut-based company said in a statement on Wednesday.

NanoViricides, which is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza and HIV, estimated that it currently has sufficient cash in hand to support operations for at least two years at the current rate of cash expenditure, according to the statement.

NanoViricides also estimated that it has sufficient cash in hand to support "initial human clinical trials of its first drug candidate, a broad-spectrum anti-influenza drug in its FluCide&trade program," it said.

The shares rose 1.2 percent to 61.7 cents at 9:56 a.m. They traded as high as 70 cents and as low as 58 cents in earlier trading. The stock gained 28 percent since the beginning of the year through Tuesday.

During the quarter, the company spent $1.4 million in research and development expenses, or R&D, and $831,400 in general and administrative expenses, or G&A, including stock-based expenses. The company's rate of expenditure was in line with the company's budgeted targets.

The company also said it had raised $6 million from three family offices and a charitable foundation in February, as announced previously. The company announced full retirement of its Series C convertible preferred stock held by Seaside 88, LP, with a cash payment of approximately $2.01 million.

NanoViricides said that all of its drug development programs are progressing satisfactorily. The company is advancing its oral broad-spectrum anti-influenza drug candidate, NV-INF-2, towards IND-enabling studies.

"This may be the first ever nanomedicine drug of any kind that is active when administered orally. This drug is being developed for out-patient influenza cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers," the company said.

The company also continues to develop its injectable anti-influenza drug, NV-INF-1, towards IND-enabling studies. "This drug candidate has much greater activity than the oral drug, and is intended for use in hospitalized patients with influenza or potentially influenza-like illness. The company believes it will be useable in immuno-compromised populations, and may receive an orphan drug classification for this indication," the statement said.

Paragon Care raises funds to repay debt, proposes FY14 dividend payment

Tue, 21 May 2013 15:00:00 +1000

Paragon Care (ASX: PGC) is raising $2 million through a placement at $0.27 to sophisticated and professional investors, with the funds to repay bank debt, fund working capital and provide for a dividend at the end of the current financial year.

The placement will comprise the Tranche 1 placement of $1.3 million, with Tranche 2 for $0.7 million subject to shareholder approval. Paragon's shares last traded at $0.37 before the announcement.

Paragon, which is focused on the services to Australia’s health and aged care markets, will also launch a Share Purchase Plan to subscribe up to another A$15,000 in shares - which has the potential to further increase it's cash balance, and allows existing shareholders to benefit from the discount applied to the placement.

The ageing Australian population provides a growing opportunity for Paragon services, with the company a distributor and manufacturer of premium durable medical equipment to the acute and aged care markets.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Paragon Care to raise capital

Fri, 17 May 2013 13:50:00 +1000

Paragon Care (ASX: PGC) plans to undertake a capital raising and has gone into an ASX trading halt.

The halt will last until the earlier of an announcement being made to the market, or the opening of trade on Tuesday, 21st May 2013.

Paragon, a provider of integrated services for Australia's health and aged care markets, expects its full year revenue and EBITDA to be towards the high end of the guidance previously provided to the market after recording a net profit of $564,000 for the first half ended 31 December 2012.

This is up 165% from the previous corresponding period.

NanoViricides strengthens management team with new interim CFO

Tue, 14 May 2013 04:27:00 +1000

NanoViricides (OTCBB:NNVC) says it has hired Meeta Vyas as an interim CFO, which the company says will strengthen its executive team as it moves its drug candidates toward clinical trials.

Vyas, who is married to president and chairman of NanoViricides Anil R. Diwan, is a former CEO of a public company, and has more than 25 years experience in performance and process improvement of both publicly listed companies and non-revenue producing entities, said the company in its release, in areas ranging from finance and operations to strategy and management.

She is also noted as being the first Indian woman to be named CEO of a publicly listed U.S. corporation, Signature Brands Inc, where she was credited with the turnaround plan that resulted in a return to profitability and growth for the company.

Vyas later moved on to become the CEO of the World-Wide Fund for Nature - India (WWF-India) and then VP of the National Audubon Society (USA), both non-revenue generating entities.

NanoViricides also noted that earlier in her career, she was responsible for designing the strategy and initiating the implementation plan for the information technology outsourcing program at General Electric.

Also at GE, the company said Vyas ran GE Appliances' Range Products business unit having revenues exceeding $1 billion, where her team doubled operating income in less than two years.

"We have significantly strengthened our executive team with the addition of Meeta Vyas as interim CFO," said CEO of NanoViricides in the release, Eugene Seymour.

"As we move our drug candidates towards clinical trials, Meeta's appointment not only improves our corporate governance but also sets the stage for further evolution of the company."

Including the company's prolific FluCide program, it currently has six “commercially important” drug candidates in its pipeline that together address a market size greater than $40 billion. Those include drugs for use against HIV, viral eye diseases, Herpes, and Dengue viruses.

It has said that both drugs in its FluCide program have shown “very high effectiveness” in preclinical animal studies of two distinctly different influenza A virus infections, often showing better results than the current standard of care - Tamiflu.

Suda Limited’s ArTiMist™ shown to be a “superior” malaria treatment for children

Tue, 30 Apr 2013 11:00:00 +1000

Suda Limited’s (ASX: SUD) ArTiMist™ has proven to be an effective treatment for children with malaria, as well as superior to the current treatment for severe malaria, in a recent African trial.

Preliminary results of a phase three African malaria trial in children has demonstrated that sub-lingual (under the tongue) ArTiMist™ is superior to quinine.

Results support the proposal that sub-lingual ArTiMist™ is an effective treatment for children with severe or complicated falciparum malaria, or uncomplicated falciparum malaria with gastrointestinal complications.

The results also strongly support the potential role that ArTiMist™ may be able to play in the early interventional treatment of malaria in these cases.

The trial was carried out in the malaria endemic areas of Rwanda, Burkina Faso and Ghana over a 22 month period from November 2010 to September 2012.

The study’s primary objective was to demonstrate that sub-lingual ArTiMist™ was superior to IV quinine in the reduction of the parasite counts by over 90% within 24 hours in children with severe or complicated falciparum malaria, or uncomplicated falciparum malaria with gastrointestinal complications.

The results of the trial demonstrated that 95.6% of patients treated with ArTiMist™ had their parasite counts reduced by over 90% in the first 24 hours.

By comparison, only 40.6% of the quinine treated patients had the same reduction.

The secondary efficacy parameters PCT, PRR24, PCT50, PCT90 demonstrated a statistically significant difference overall between the treatments in both efficacy populations (p < 0.005), further demonstrating the superiority of ArTiMist™ over IV quinine in clearing parasites.

There were 10 early treatment failures for quinine treated subjects. One quinine treated subject required rescue therapy.

For ArTiMist™ treated subjects there were no early treatment failures, and no patient required rescue therapy.

Quinine did not appear to be better than ArTiMist™ for any of the secondary endpoints included in this study.

There were no Treatment Related Adverse Events (TEAEs), deaths or neurological sequelae for either treatment.

Suda had around A$1.3 million in cash at the end of the March quarter 2013.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Suda Limited to release Phase III results for malaria drug

Tue, 30 Apr 2013 08:30:00 +1000

Suda Limited (ASX: SUD) is poised to release Phase III trial results for the company's malaria drug known as ArTiMist™, with the ASX granting the company a trading halt - with its shares placed in pre-open.

ArTiMist™ has been designed to address both the pre-referral and hospital based treatment of paediatric uncomplicated malaria with gastrointestinal complications, such as vomiting and diarrhoea, and severe malaria.

Earlier in the month Suda announced advancements towards the potential commercialisation of the drug,
having successfully completed its first manufacturing scale-up.

Importantly, the product has passed contract manufacturing partner Therapex’s quality assurance testing and is within agreed specifications.

The halt will last until the earlier of an announcement being made to the market, or the opening of trade on Wednesday 1st May 2013.

NanoViricides shares rally on potential effective treatment for H7N9 virus

Tue, 23 Apr 2013 06:05:00 +1000

NanoViricides (OTCBB:NNVC) shares shot up on Monday after it said it anticipates that the oral and injectable versions of its FluCide drug candidate would be effective against the new H7N9 strain of the flu that has caused a slew of deaths in China of late.

Shares of the biopharmaceutical company were lately up almost 7 per cent to 63 cents approaching market close, soaring to as high as 69 cents just after the news was released.

Both the injectable drug, for use in severely ill patients with the flu, and the oral version for less sick out-patients, bear a "virus-binding ligand" that mimics sialic acid, the company told investors this afternoon.

This ligand is capable of substituting for both the mammalian form or the avian form, it added.

Since the novel H7N9 (2013) virus is transitioning from avian to human host, the dual biomimetic capability of our FluCide ligand should have a favorable impact," NanoViricides said in the release.

The FluCide drugs are based on NanoViricides' biomimetic technology, which mimicks the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide polymeric micelle. The company notes that all flu viruses bind to the sialic acid receptors, even if they rapidly mutate.

According to the company statement on Monday, the Center for Disease Control (CDC) and scientists from China and Japan have reported that based on the genetic structure of the new strain, this virus is likely to bind well with the mammalian form of sialic acid.

The virus is also said to be reported to bear other mutations that allow it to infect mammalian hosts effectively.

"Existing H7-vaccine viruses are not well matched to this novel H7N9 virus, and new vaccine development will take some time. This H7N9 is resistant to amantadine and rimantadine, as are most US and European Influenza A virus strains," the company noted.

Though the virus is suggested to be susceptible to Tamiflu and Relenza, certain mutations suggest resistance,NanoViricides noted, citing CDC authors Dr. Uyeki and Dr. Cox, who say that clinical research is "urgently needed on new antiviral agents, including drugs with different

mechanisms of action".

Indeed, FluCide is based on a completely new mechanism of action, where the drug micelle is designed to bind to the virus particle through "multi-denate interactions" and then to spread onto the virus surface, thereby covering the entire virus particle.

Unlike antibodies, the company's nanoviricide agents are designed to perform their antiviral effect even if the immune system is compromised, and can be designed to have as many as 20 or even larger numbers of virus-binding ligands.

Both drugs in its FluCide program have shown “very high effectiveness” in preclinical animal studies of two "distinctly different" influenza A virus infections, NanoViricides noted, routinely showing superiority to Tamiflu, the current standard of care.

Flucide drugs showed complete survival, or 22 plus days, while Tamiflu resulted in only 8 to 9 days of survival, the company said. Untreated animals died within five days.

The results are expected to correlate well with impending human clinical studies, it added. The company has previously reported that it is working on cGMP production of its drug candidates in the near future. The bidding phase for subcontracts for the production and laboratory facilities has already begun.

NanoViricides has a pre-investigational new drug application meeting with the U.S. FDA at the end of March for its injectable FluCide candidate.

Including the FluCide program, it currently has six “commercially important” drug candidates in its pipeline that together address a market size greater than $40 billion. Those include drugs for use against HIV, viral eye diseases, Herpes, and Dengue viruses.

Suda successfully scales up manufacture of malaria treatment spray

Tue, 16 Apr 2013 15:40:00 +1000

Suda (ASX: SUD) is making rapid advancements towards the commercialisation of its malaria treatment spray for children, ArTiMist™, having successfully completed its first manufacturing scale-up.

Importantly, the product has passed contract manufacturing partner Therapex’s quality assurance testing and is within agreed specifications.

ArTiMist™ is a ready-to-use, sub-lingual sprayable reformulation of artemether which has been developed specifically for children with severe malaria.

Suda has the exclusive clinical development, manufacturing and distribution right for ArTiMist™ in Africa, India, Asia and Asia Pacific.

Therapex manufactured the first of the 10,000 unit commercial stability batches in late February.

The batch was held and filled over an extended period to mimic large scale production conditions.

A further batch of 10,000 units will now be manufactured.

On completion of the second batch, the samples will be placed on a commercial stability program to assess and confirm that the long term stability of the commercial batches is the same as the developmental and clinical batches.

Suda had cash in hand of A$1.06 million at the end of December 2012.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Suda to buy NovaDel's NovaMist oral spray formulation technology

Mon, 08 Apr 2013 13:10:00 +1000

Suda (ASX:SUD) has signed a sale and purchase agreement with NovaDel Pharma for the purchase of intellectual property and inventory relating to the oro-mucosal NovaMist platform technology.

NovaDel currently holds a broad portfolio of granted patents and pending patents. The patent portfolio covers the buccal/mucosal delivery of a wide range of drugs covering important areas such as the Central Nervous System (CNS), Erectile Dysfunction (ED), Pulmonary Arterial Hypotension (PAH), biologically active peptides hormones such as, insulin and cyclosporine.

They cover antibiotics, antifungals, antivirals, anti-asthmatics, barbiturates and opioids as well as, polar and non-polar sprays or capsules.

The proprietary NovaMist technology enables rapid delivery of drugs into the bloodstream, which can result in a faster onset of action and potential patient benefits in compliance, convenience and safety.

SUDA is working with an external consultant to determine the primary drug targets from the existing portfolio and to identify the future drug targets.

The key product in development, Duromist, is a stable solution of lingual Sildenafil (the active ingredient in Viagra) that has shown preliminary bioequivalence to Viagra tablets in early clinical trials.

The acquisition will include a cash consideration of $400,000 and issue of 50 million shares and 10 million options expiring on 31 December 2015.

It had a cash balance of $1.06 million at the end of December 2012.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

NanoViricides to present at key BioPhysics seminar this week

Fri, 22 Mar 2013 01:50:00 +1100

NanoViricides (OTCBB:NNVC) says that its president, Dr. Anil Diwan, will present at a seminar later this week at the University of California in Los Angeles, which will be hosted by the Center for Biological Physics and with the California NanoSystems Institute.

Dr. Diwan's talk, entitled "Designing a Nanoviricide - Biophysics is the Key" will take place on Friday March 22nd, the company said in a statement Wednesday.

"I am honored to have this opportunity to discuss our work with eminent biophysicists that are researching the interactions and structural stability of viruses," said Dr. Diwan. "Biophysics is the key to understanding our approach to develop NanoViricides, our novel biomimetic agents designed to destroy viruses."

Including the company's FluCide program, NanoViricides currently has six “commercially important” drug candidates in its pipeline that together address a market size greater than $40 billion. Those include drugs for use against HIV, viral eye diseases, Herpes, and Dengue viruses.

Its drugs use NanoViricides, which are a biomimetic decoy designed to fool a virus particle into binding to it and thereby capturing the virus particle and rendering it harmless.

Its FluCide program consists of the injectable anti-flu drug, NV-INF-1,

which is intended for use in hospitalized patients with the flu, and its oral anti-influenza candidate, NV-INF-2, which may be the first ever nanomedicine drug of any kind that is active when administered orally.

Both drugs have shown “very high effectiveness” in preclinical animal studies, NanoViricides noted, routinely showing substantial superiority to Tamiflu, the current standard of care.

The company has also said that a single course treatment for out-patients is a "highly sought after" goal in flu therapeutics and that it estimates the market size for anti-influenza drugs to be roughly $4 to $7 billion worldwide.NanoViricides said it believes that if its FluCide drugs become available, the influenza drug market size could expand substantially.

The company, which is in the midst of a renovation project at its facility in Connecticut, said Wednesday that the challenges and opportunities for understanding the behaviour of virus-nanoviricde interactions, and the results of nanoviricide studies against various viruses, will be discussed at the seminar later this week.

Benitec Biopharma to seek US regulatory nod to start Hepatitis C drug trial

Fri, 08 Mar 2013 14:20:00 +1100

Benitec Biophrama (ASX:BLT) is progressing through the U.S. regulatory approvals that would enable it to start the clinical trial of its lead therapeutic TT-034 drug on Hepatitis C patients.

The regulatory process would include recombinant DNA Advisory Committee (RAC) and Investigational New Drug (IND) filings that would enable it to start patient enrolment and dosing in the second half of calendar 2013.

Benitec is working with Synteract, which is a contract research organisation, and has carried out a range of activities to speed up the start of the clinical trials.

These include completion of an in-depth program analysis of requirements for recombinant DNA Advisory Committee and Investigational New Drug filing, and requirements for trial commencement.

These analyses have confirmed the positive assessment Benitec conducted as part of the Tacere acquisition process in October.

Benitec has now confirmed both primary and secondary sites for the proposed trial, providing access to appropriate patient populations and experienced and motivated principal investigators.

It has also finalised the RAC filing, which will be submitted in early April 2013, with a decision to be announced in June 2013.

The IND filing will follow the approval of the RAC application.

TT-034 utilizes a mechanism of action mediated by RNA interference (RNAi), an evolutionarily conserved cellular process for sequence-specific gene silencing.

TT-034 uses a synthetic DNA expression template to simultaneously express three short hairpin RNAs (shRNAs) that cleave three non-overlapping and well-conserved sequences within the HCV genome, thereby rendering it incapable of further replication and packaging into nascent virions.

At the end of December 2012, the company had a cash balance of $1.21 million and more recently raised $0.8 million via a private placement.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

NanoViricides shares gain as it takes the lead at two sessions for the Symposium on Nanomedicines

Thu, 07 Mar 2013 05:08:00 +1100

NanoViricides (OTCBB:NNVC) saw its shares surge over seven per cent Wednesday, after announcing that president Anil Diwan will lead section 1 of the Symposium on Nanomedicines: Charting a Roadmap to Commercialization, called “Designing Nanomedicines”.

Diwan will lead section 1 of the symposium, being held today and tomorrow in Rockville, Maryland, with Dr. Mostafa Analoui of the Livingston Group. Additionally, NanoViricides’ chief scientific officer Randall Barton will lead section 2, called “Preclinical Pharmacology”, with Dr. Benjamin Yerxa of Liquidia Technologies.

Shares of the company were up 7.09 per cent as at about 12 p.m. EDT, trading at 68 cents.

“Designing Nanomedicines” will provide panelists from various medical universities and research centres across the U.S. with a sampling of the multi-faceted nanomedicine technologies and their current and future applications, the company noted.

The panelists will briefly present design aspects of their respective work in nanomedicines and then discuss several key questions that should be addressed in developing nanomedicines against diseases that currently have no good drugs.

NanoViricides said Diwan will focus on the questions of how to design antiviral biomimetic nanomedicines, the importance of “active” targeting for such drugs, and the company’s success in developing the first ever orally active nanomedicine with its oral FluCide anti-influenza drug candidate.

He will also look at NanoViricides’ success in achieving “broad-spectrum” effectiveness, and the long, sustained effectiveness of the company’s anti-HIV and anti-influenza drug candidates.

NanoViricides' injectable anti-flu drug, NV-INF-1, is intended for use in hospitalized patients with the flu. The company said it believes it will be useable in immuno-compromised populations, and may receive an orphan drug classification for this indication.

Its oral anti-influenza drug candidate, NV-INF-2, may be the first ever nanomedicine drug of any kind that is active when administered orally. This drug is being developed for out-patient influenza cases, and may also be useful for the protection of health care workers.

Both drugs in its FluCide program have shown “very high effectiveness” in preclinical animal studies, NanoViricidesnoted, routinely showing substantial superiority to Tamiflu, the current standard of care.

The FluCide drugs are intended for use against most types of flu viruses, including H1N1 or the “swine flu”, H3N2, novel strain, and bird flu.

The drugs are based on NanoViricides' biomimetic technology, which mimicks the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide polymeric micelle. The company noted that all flu viruses bind to the sialic acid receptors, even if they rapidly mutate.

“The sustained effect may enable single dose therapy for influenza and other acute viral illnesses,” saidNanoViricides in a statement Tuesday.

“In addition, this sustained effect property should result in strong patient benefits for HIV/AIDS patients by reducing the number of times the drug needs to be taken, to perhaps as little as once-a-week.”

The company also noted that a single course treatment for out-patients is a highly sought after goal in influenza therapeutics and that it estimates the market size for anti-influenza drugs to be roughly $4 to $7 billion worldwide.NanoViricides said it believes that if its FluCide drugs become available, the influenza drug market size could expand substantially.

NanoViricides armed with $18 mln of cash after retirement of Series C preferred stock

Fri, 01 Mar 2013 07:44:00 +1100

NanoViricides (OTCBB: NNVC) says it has retired the remainder of its Series C convertible preferred stock previously purchased by Seaside 88 with a cash payment, and said it holds around $18 million of cash in hand following the transaction.

The drug developer believes that these funds are sufficient, it said, for more than two years of operating expenses, and to advance its anti-flu drugs into initial human clinical trials.

The deal with Seaside 8 was done through a mutual agreement, NanoViricides added.

Shares of the company rose almost 10% in early deals Thursday, to 48.3 cents.

"We have been very happy with the strong financial support that Seaside has provided to the company," said chairman Anil R. Diwan, adding that Seaside has invested a total of $25 million into the company over the past few years.

"Their funding has allowed us to focus on drug development without any fund-raising distractions. We have been able to advance our influenza drug pipeline with the use of this financing. Further, we have been able to obtain sufficient capital to fund our upcoming studies through IND filing and initial human clinical trials."

NanoViricides recently sold $6 million of its Series B convertible debentures to three family investment offices and a charitable foundation, and as a result, determined that the retirement of its preferred Series C stock was in the best interests of its shareholders.

Around $2 million of the $6 million it raised was used to retire the Series C shares, it added.

The news, which was announced late Wednesday, came just a day after the company announced that the renovation of the facility for its new clinical-scale cGMP production plant has begun.

The company said Tuesday it reached “a new milestone” with the start-up of the renovation of its cGMP (current good manufacturing practice) facility, which is being designed to produce sufficient quantities of the drugs needed for human clinical trials that will test various nanoviricide drug candidates as they advance into the clinical pipeline.

According to the drug maker, its oral anti-influenza drug candidate, NV-INF-2, may be the first ever nanomedicine drug of any kind that is active when administered orally. This drug is being developed for out-patient influenza cases, and may also be useful for the protection of health care workers.

The FluCide drugs are intended for use against most types of flu viruses, including H1N1 or the “swine flu”, H3N2, novel strain, and bird flu.

Including the FluCide program, the company said it currently has six commercially important drug candidates in its pipeline that together address a market size greater than $40 billion. Those include drugs for use against HIV, viral eye diseases, Herpes, and Dengue viruses.

NanoViricides starts renovation for pilot production and lab facility, shares rise

Wed, 27 Feb 2013 08:28:00 +1100

NanoViricides (OTC:NNVC) on Tuesday saw its share price spike over 28 per cent as it announced that the renovation of the facility for its new clinical-scale cGMP production plant has begun.

The company said it has reached “a new milestone” with the start-up of the renovation of its cGMP (current good manufacturing practice) facility, which is being designed to produce sufficient quantities of the drugs needed for human clinical trials that will test various nanoviricide drug candidates as they advance into the clinical pipeline.

In other news, it said that on Monday an unusual pattern in the trading of its stock was brought to its attention by concerned shareholders.

“This highly unusual pattern involved selling of very large amounts of the company’s common stock shares in a short time prior to the close of trading, leading to a large drop in the share price,” it stated in a release Tuesday.

“The company does not have any knowledge of who the sellers were.”

Shares of the company were up nine cents this morning, trading at 41 cents as at about 10:25 a.m. EDT.

NanoViricides stressed that it is unaware of any fundamental basis for the “unusual trading pattern” or the associated share price drop.

“The company has no knowledge of any business related events or of any fundamental changes in its business, programs or technology developments, that would constitute an adverse business event,” it noted, adding that all of it programs are on track, and that it has sufficient cash in hand to carry out its current plans.

Last week, NanoViricides reported that with the $6 million it recently raised, and its cash position at the end of its latest quarter, it has about $20 million in hand and said it has developed a strategy to minimize its capital costs in the construction of the production facility.

With its current cash position, the company believes that it can support operations for at least two years, perform the necessary new drug application (IND)-enabling studies for its anti-flu drug candidates and begin human clinical studies “in a reasonable timeframe”.

The FluCide drugs are intended for use against most types of flu viruses, including H1N1 or the “swine flu”, H3N2, novel strain, and bird flu.

Benitec Biopharma to raise funds

Mon, 25 Feb 2013 12:20:00 +1100

Benitec Biopharma (ASX: BLT) is preparing to raise capital, with the ASX granting the company a trading halt this morning - while placing its shares in pre-open.

Benitec is focused on unique patent protected long lasting gene silencing technology.

The halt will last until the earlier of an announcement being made by the market, or the opening of trade on Wednesday 27th February 2013.

Bacterin shares fall on lower expected Q4 revenues, anticipates growth in 2013

Sat, 23 Feb 2013 01:46:00 +1100

Bacterin International Holdings (NYSE MKT:BONE) said Wednesday that it expects to report revenues of around $8.1 million for its fourth quarter, down from $9.1 million in the year earlier period, sending shares lower this afternoon.

The developer of bone graft material and antimicrobial coatings for medical applications announced today its preliminary revenues for the quarter that ended December 31.

"Revenues during the fourth quarter were softened by orders anticipated to close during the period, which have shifted into our prospective pipeline for 2013," said CEO Guy Cook.

"Although we were successful in generating orders during the fourth quarter, our revenues for the year were lower than our prior guidance.

"I have been pleased with the progress we have made to adapt our strategy to mitigate the competitive headwinds and pricing pressure we are experiencing in the marketplace."

Revenues for the full year are anticipated to be $33 million - a 9% increase over the $30.1 million seen in 2011. Excluding the impacts of distributor stocking orders, revenues for the full-year of 2012 would have increased 14% over 2011, the company said.

Looking ahead, the company said it expects 2013 revenues to be between $38 and $40 million, which represents an increase of about 15% to 20% over 2012.

"A component of our growth strategy going forward will be to create additional sales channels that will continue to grow our top-line and enhance our market position," continued Cook.

"These opportunities represent potential upside to our guidance for 2013 and have not been included due to the intricacies in determining the timing of these transactions."

Bacterin's technology optimizes the growth factors in human allografts to promote bone, subchondral repair and dermal growth. Its products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, bone growth in foot and ankle surgery, cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries.

In addition to bone graft material, the company also makes bioactive coatings for various medical device applications, including antimicrobial coatings designed to inhibit biofilm formation and microbial contamination.

Shares of Bacterin were down more than 11% to 99 cents on Wednesday afternoon.

NanoViricides says “strong” cash position can support clinical trials of influenza drugs

Wed, 20 Feb 2013 07:43:00 +1100

NanoViricides (OTC:NNVC) Tuesday said that with the $6 million it recently raised, and its cash position at the end of its latest quarter, it has about $20 million in hand to support human trials of its anti-flu FluCide drugs.

With its “strong cash position”, the company said it believes that it has sufficient funds for the necessary Investigational New Drug Application (IND) enabling studies for its anti-influenza drug programs and to file an IND with the U.S. Federal Drug Administration (FDA).

The company also said that its current cash position can support operations for at least two years at the current rate of cash expenditure.

As of December 31, NanoViricides said it had roughly $13.88 million in cash and equivalents, and $801,000 in prepaid expenses. Shareholder equity stood at about $15.6 million.

In comparison, the company said that it had $12.9 million in cash and equivalents, $438,000 in prepaid expenses, and $12.79 million in shareholder equity as of September 30.

It spent about $710,000 on research and development and $533,400 in general and administrative expenses in the latest quarter, in line with its budgeted targets.

The company said it has no long term debt, or short term debt, other than working capital accounts payables, and said all of its drug development programs are “progressing satisfactorily”.

Its injectable anti-influenza drug, NV-INF-1, also continues to be advanced, and is intended for use in hospitalized patients with the flu. The company said it believes it will be useable in immuno-compromised populations, and may receive an orphan drug classification for this indication.

Both drugs in its FluCide program have shown “very high effectiveness” in preclinical animal studies, NanoViricidesnoted, routinely showing “substantial superiority” to Tamiflu, the current standard of care.

The FluCide drugs are intended for use against most types of flu viruses, including H1N1 or the “swine flu”, H3N2, novel strain, and bird flu.

The company is also developing drugs against HIV, viral eye diseases, Herpes, and Dengue viruses.

NanoViricides to present at New York conference tomorrow, shares gain

Tue, 12 Feb 2013 07:59:00 +1100

Shares of NanoViricides (OTCBB:NNVC) advanced as the company said Monday that its president, Dr. Anil Diwan, will present at the Annual BIO CEO and Investor Conference in New York City tomorrow.

The presentation, which is scheduled for 11:30am ET in the Conrad Room, will take place at the Waldorf-Astoria Hotel.

It stock was lately up 1% in afternoon trade Monday, at 48.1 cents.

The company earlier this month said it raised $6 million from four equity investors, saying it now has enough cash for the first human clinical trials of its anti-flu drug candidate - FluCide.

NanoViricides' injectable anti-flu drug, NV-INF-1, is intended for use in hospitalized patients with the flu, and the company has said it could receive an orphan drug classification for use in immuno-compromised patients. The drug could potentially be used as well in a doctor's office for the treatment of less serious cases.

It has also developed an oral anti flu drug candidate, NV-INF-2, which it has said may be the "first ever nanomedicine drug of any kind that is active when administered orally." The drug is being developed for out-patient flu cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers.

Its FluCide drug candidates have already shown what the company calls "strong effectiveness" against H1N1 and H3N2 flu viruses in animal studies, with 100 to 1,000 times greater viral load reduction than the current standard of care known as Tamiflu.

The company now reports having around $19 million of cash in hand with the recent raise, which will last it through the first human trials of FluCide.

It said it believes that its FluCide drug candidates will be effective against most, if not all, flu viruses, including H3N2 or H1N1, seasonal flus, bird flu and new flu strains.

This is because the drugs are based on NanoViricides' biomimetic technology, which mimicks the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide polymeric micelle. The company noted that all flu viruses bind to the sialic acid receptors, even if they rapidly mutate.

The market size for anti-flu drugs, according to NanoViricides, is currently estimated to be around $4 to $7 billion worldwide.

NanoViricides has already conducted a pre-IND meeting with the U.S. FDA for its injectable anti-flu drug last March. It is now working on studies needed for the investigational new drug submission.

Last month, the company hired AES Clean Technology to design, engineer and construct the “cleanroom suite” for its laboratory and cGMP pilot production facility project.

The company’s cGMP (current good manufacturing practice) facility is being designed to produce sufficient quantities of the drugs needed for human clinical trials that will test various nanoviricide drug candidates as they advance into the clinical pipeline.

Aside from the flu drugs, the company is also developing drugs against HIV, viral eye diseases, Herpes, and Dengue viruses

Sigma Pharmaceuticals partners with Pharmacy Alliance

Wed, 06 Feb 2013 17:00:00 +1100

Sigma Pharmaceuticals (ASX: SIP) has entered into a deal with Pharmacy Alliance that will see the opening of at least 30 new Amcal stores in 2013, with more in the pipeline.

The partnership will result in an initial 30 Pharmacy Alliance members moving into the Amcal brand, owned by Sigma – Australia’s largest pharmacy-led network.

Since the creation of Allied Master Chemists of Australia (Amcal) in 1937, the brand’s network has grown to over 300 stores.

Together, Sigma’s broader Amcal, Amcal Max, Guardian Pharmacy and Pharmacy Alliance members now represent 900 pharmacies nationally.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

NanoViricides raises $6 mln, has enough for first human clinical trials

Wed, 06 Feb 2013 02:47:00 +1100

NanoViricides (OTCBB:NNVC) has raised $6 million from four equity investors, saying it now has enough cash for the first human clinical trials of its anti-flu drug candidate - FluCide.

The $6 million it has raised announced today came from four equity investors, including three prior family office investors, and a charitable foundation.

The company now reports having around $19 million of cash in hand with the recent raise, which will last it through the first human trials of FluCide.

"These family funds are sophisticated equity investors that have always shown a strong faith in both theNanoViricides(R) platform technology and our unique vision," said CEO Eugene Seymour, in a statement Monday.

"With these new investments, they continue to be long term investors in NanoViricides, Inc. We are extremely pleased with their continued support."

The investors bought unsecured convertible debentures with a four year term, bearing an annual interest rate of 8%m and additional interest payable in restricted common stock and warrants. They can convert the principal and any accrued interest into common stock at a fixed price of $1 per share.

The company said it believes that its FluCide drug candidates will be effective against most, if not all, flu viruses, including H3N2 or H1N1, seasonal flus, bird flu and new flu strains.

The company noted that all flu viruses bind to the sialic acid receptors, even if they rapidly mutate.

NanoViricides has already conducted a pre-IND meeting with the U.S. FDA for its injectable anti-flu drug last March. It is now working on studies needed for the investigational new drug submission.

Last month, the company hired AES Clean Technology to design, engineer and construct the “cleanroom suite” for its laboratory and cGMP pilot production facility project.

Aside from the flu drugs, the company is also developing drugs against HIV, viral eye diseases, Herpes, and Dengue viruses. Its share price rose on the back of the news Monday, by 0.6%, to 48.3 cents.

Paragon Care's shares shooting higher

Tue, 29 Jan 2013 15:20:00 +1100

Paragon Care's (ASX: PGC) shares hit $0.42 intra-day today, which is 35% higher than the closing price on Friday 25th January, with the company receiving an ASX price query speeding ticket.

The company provides integrated services for Australia's health and aged care markets.

Paragon said that it was not aware of any material information that has not been released to the market which could explain the recent trading in its shares.

The ASX did ask Paragon: Is there any reason to think that there may be a change in the operating result before abnormal items and income tax so that the figure for the half year ending 31 December 2012 would vary from the corresponding period by more than 15%?

Paragon responded: 'The process for preparing financial statements (including determining the financial performance) for the period ending 31 December 2012 is incomplete, ongoing and remains subject to further confirmation and review.

'However, based on the work to date, the company expects the operating result before tax for the 2013 financial year to be in the range announced at the company's AGM on 28 November of between $0.7 and $1.2 million.'

NanoViricides moves ahead with anti-flu drug program shown to be superior to Tamiflu

Thu, 17 Jan 2013 03:58:00 +1100

NanoViricides (OTCBB:NNVC) provided Tuesday an update to its flu program, and said that both its oral anti-flu and related injectable drug have now shown "significantly superior" results to Tamiflu against an H1N1 strain of the flu that is the same type as the 2009 epidemic virus.

The previously reported animal study results were reiterated as the company also announced that a "highly optimized" floor plan for its cGMP production facility for its nanoviricide drugs has now been completed by its design team.

The development-stage company is developing its NanoViricides class of drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal influenza, HIV, oral and genital herpes, viral diseases of the eye, Dengue fever, and Ebola virus, among others.

It is first focused on advancing its FluCide drug candidates through the regulatory process, and has already designed the toxicology and safety pharmacology studies for the IND submission and the first-in-human clinical trials of its FluCide investigational anti-flu product.

"The need for an effective, broad-spectrum, anti-influenza drug cannot be overstated," said CEO Eugene Seymour. "The current 2012 influenza season is already considered to be an epidemic.

"The current vaccine did not work well even though the same strain of H3N2 that is causing serious cases, was included in the vaccine mix. Vaccine effectiveness is only around 60%.

"In the previous 2009 epidemic, the virus swept the world long before a vaccine could become available. The 2009 virus was a novel strain, even though it was a subtype of H1N1. Vaccines are highly specific (narrow-spectrum) because they elicit antibodies in the human host, and antibodies are by nature very specific to their target."

"We have clearly demonstrated that the design platform technology for NanoViricides allows development of powerful broad-spectrum antiviral drugs," added president Anil R. Diwan.

"We have developed a small chemical ligand that mimics both the mammalian (or a-2,6-) and avian (or a-2,3) forms of the native sialic acid receptor of influenza viruses.

"The ligands are designed to look very much like (mimic) the sialic acid to the influenza viruses, and the high density of the ligands would force the virus to land onto the nanoviricide and get destroyed by the hidden 'tails' of the nanomicelle that snap out and merge into the viral surface lipid coat."

Last year, the company reported that its anti-flu drugs have reduced viral loads from "tens to hundreds of times" lower levels than Tamiflu. Both the oral and injectable forms of the drug protected the lungs of the animals, which was reflected in the "strong increase in survival time in the FluCide-treated animals as compared to Tamiflu", the drug maker said.

"We are rapidly advancing towards our goal of filing an IND with the FDA for Influenza based on the guidance we received in our previous pre-IND meeting with the FDA," concluded Diwan.

Shares in the company advanced more than 2.3% to 49.8 cents late this morning.

NanoViricides hires AES Clean Technology for pilot production and lab facility

Wed, 16 Jan 2013 04:16:00 +1100

Drug maker NanoViricides (OTCBB:NNVC) Monday announced that it has hired AES Clean Technology to design, engineer and construct the “cleanroom suite” for its laboratory and cGMP pilot production facility project.

NanoViricides noted that the cleanroom suite makes up the main cGMP manufacturing sections of the pilot plant. The suite provides for walk-in, process scale, class 100 laminar hoods; walk-in, process scale chemical fume hoods; class 1,000 and class 10,000 work areas; entry airlock and egress systems.

"AES has the industry expertise in designing and building modular, validated, cGMP manufacturing suites for pharmaceutical industries," said president Anil R. Diwan, PhD.

"We are very pleased to have such experts working with us to enable this project in a cost effective fashion without compromising on quality or performance."

AES is known for turnkey design, manufacturing, and construction, of modular cleanroom systems. According to the AES website, modular cleanroom technology delivers “more speed, cleanliness, quality, and repeatable performance” to a cleanroom project.

Last month, NanoViricides announced that its cGMP facility will be built by renovating an existing 18,000 square foot light manufacturing plant on a 4.2 acre lot in Shelton, Connecticut.

While AES will be responsible for the cGMP manufacturing suites space, NanoViricides also recently hired ID3A architects as the principal architect for the project. The two companies join MPH Engineering, which will provide project management and engineering services.

The drug substances produced in the company’s new facility will be delivered to a third party for final processing and labeling, as required, for human clinical trials when ready.

NanoViricides is now conducting further studies that are necessary before producing large batches for the safety and toxicology studies. The injectable anti-flu drug, NV-INF-1, is intended for use in hospitalized patients with the flu, and the company has said it could receive an orphan drug classification for use in immuno-compromised patients.

It has also developed an oral anti flu drug candidate, NV-INF-2, which it has said may be the "first ever nanomedicine drug of any kind that is active when administered orally."

The drug is being developed for out-patient flu cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers.

Apollo Consolidated extends Bombora gold system

Tue, 15 Jan 2013 13:00:00 +1100

Apollo Consolidated (ASX: AOP) has intersected wide zones of gold anomalism associated with disseminated sulphides in all six holes drilled recently at the Bombora prospect in Western Australia, which has extended the system.

Bombora is one of the three advanced targets at the company’s Rebecca Project located 150 kilometres east of Kalgoorlie.

The project is located in the Pinjin area of the southern Laverton Tectonic Zone, one of the key Goldfields mineralised corridors and host to a number or multi-million ounce gold deposits.

All assays have now been returned from the follow-up reverse circulation program completed at the northern extensions of the prospect in late 2012.

Better intercepts include 6 metres at 3.54 grams per tonne (g/t) gold within 29 metres at 1.04g/t gold; 6 metres at 1.28g/t gold within 20 metres at 0.63g/t to the end of hole; and 8 metres at 1.4g/t gold within 24 metres at 0.68g/t gold.

Apollo Consolidated is proving up the Bombora prospect’s potential to be a substantial and under-explored gold system.

Drilling in 2012 has shown that the zone contains strong mineralisation in places and there is good potential to locate significant high grade positions within the system.

Importantly, these new assays have extended the Bombora mineralised system to at least 600 metres strike, with the system remaining open in all directions.

The northern section of holes appears to be located on the north side of a structure that has offset the mineralised Bombora zone to the west, with the zone being intercepted in the upper part of the westernmost hole.

Linear magnetic features that may represent the continuation of the Bombora horizon to the north are undrilled for a further 500 metres strike.

Likewise there is no systematic drilling of the southern strike extensions of the host horizon between Bombora and Duke, a distance of some 6 kilometres.

Rebecca Project

The Rebecca Project is believed to be a big system with widespread bedrock gold anomalism and three advanced prospects – Redskin, Duke and Bambora.

The project comprises disseminated sulphide lodes in gneiss, which are unusual host rocks but proven to host extensive mineralisation in deposits such as Tropicana, Challenger and Mt Marion.

There is good potential for higher grade material as proven by previous intercepts of 3 metres at 10.84g/t gold, 1 metre at 30g/t gold, 1 metre at 22.6g/t gold and 1 metre at 11.4g/t.

At Bambora, earlier high grade intersections include 42 metres at 7.75g/t gold, including 2 metres at 22.39g/t gold and 3 metres at 65.21g/t gold.

These latest intercepts reinforce the high grade potential.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

NanoViricides hires Id3A as architect for pilot production and lab facility

Sat, 12 Jan 2013 06:45:00 +1100

Drug maker NanoViricides (OTCBB:NNVC) Wednesday said that it has hired interior design company Id3A as the architect for its laboratory and cGMP pilot production facility project.

Shares of the company moved up 3.23 per cent as at about 10 a.m. EDT, trading at 48 cents.

The company’s cGMP (current good manufacturing practice) facility is being designed to produce sufficient quantities of the drugs needed for human clinical trials testing various nanoviricide drug candidates as they advance into the clinical pipeline.

Last month, NanoViricides announced that the facility will be built by renovating an existing 18,000 square foot light manufacturing plant on a 4.2 acre lot in Shelton, Connecticut.

The company said Id3A, as the architects for the project, will be responsible for the overall facility, including the integration of a separately constructed “clean room suite” for cGMP production.

Id3A’s co-founder, Kathyann Cowles, will serve as the principal architect for the project and will join Andrew Hahn and Phil Mader of MPH Engineering to complete the architecture, design and construction management team.

Cowles has over 30 years of experience as a licensed architect and senior project manager for design and construction projects in the academic, science, technology, corporate and research sectors, the company noted.

“[Ms.] Cowles has a unique ability to work with clients in meeting complex and detailed requirements,” saidNanoViricides president Anil R. Diwan, PhD.

“This is critically important for our challenging project that specifies not only state-of-the-art facility requirements, but also cost sensitivity, space efficiency, and a high degree of energy efficiency.”

The drug substances produced in the company’s new facility will be delivered to a third party for final processing and labeling, as required, for human clinical trials when ready.

The development stage company is developing its NanoViricides class of drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal influenza, HIV, oral and genital herpes, viral diseases of the eye, Dengue fever, and Ebola virus, among others.

It is focused on advancing its FluCide drug candidates through the regulatory process, and has already designed the toxicology and safety pharmacology studies for the IND submission and the first-in-human clinical trials of its FluCide investigational anti-flu product.

The company is now conducting further studies that are necessary before producing large batches for the safety and toxicology studies. The injectable anti-flu drug, NV-INF-1 is intended for use in hospitalized patients with the flu, and the company believes it could receive an orphan drug classification for use in immuno-compromised patients.

NanoViricides has also developed an oral anti flu drug candidate, NV-INF-2, which it has said may be the "first ever nanomedicine drug of any kind that is active when administered orally."

The drug is being developed for out-patient flu cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers.

SVC Group acquires profitable Hunter Valley mining services business

Fri, 14 Dec 2012 15:30:00 +1100

SVC Group (ASX: SVC) has inked a share purchase agreement to acquire SubZero Holdings Pty Limited, which operates an established and profitable New South Wales-based mining services business.

SubZero’s clients are almost exclusively involved in the Hunter Valley thermal coal mining industry and include majors such as BHP Billiton (ASX: BHP), Rio Tinto (ASX: RIO) and Xstrata (LON: XTA).

The company’s services include mining project support, equipment hire, offsite engineering and fabrication, onsite machining, field services and heavy machinery repairs.

In the 2012 financial year SubZero reported gross revenue of A$83.6 million, a 27% increase on the previous year, and EBITDA of $12.85 million, a 165% increase over the 2011 financial year.

There is expected to be further substantial growth in both revenue and profitability in the 2013 and 2014 financial years.

Deal terms

To satisfy the deal SVC will issue 120 million shares to the vendors at $0.25 each on settlement.

Up to an additional 10 million shares will be issued, also at $0.25 each, to repay debt owed by SubZero.

A further issue of between 15 million and 30 million shares may be made to the vendors if agreed EBIT targets are met in the year ending 30 June 2014.

Prospectus

Under the agreement, SVC will also issue a prospectus to raise a minimum of $4.5 million and a maximum of $6.5 million through the issue of new shares at $0.25 each.

The funds raised will be used to fund debt reduction; the fitout of SubZero's newly leased purpose built mining equipment and machinery maintenance and refurbishment facility at Muswellbrook; and working capital.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

NanoViricides appoints engineering firm for cGMP facility, anti-flu program development ongoing

Tue, 11 Dec 2012 06:58:00 +1100

Drug maker NanoViricides (OTCBB: NNVC) says it has retained MPH Engineering to help with the overall project management and design of its new lab and pilot production facility.

The cGMP (current good manufacturing practice) facility will be built by renovating an existing 18,000 square foot light manufacturing plant on a 4.2 acre lot in Shelton, Connecticut.

MPH will provide overall engineering and project management services for the whole facility, as well as the design and construction phases. A separate firm will be designing the cGMP area itself, while MPH will be responsible for the implementation of the entire project.

The services from MPH will be headed by Phil Mader, the director of engineering at the firm, who has 26 years of mechanical, electrical design and construction leadership experience. NanoViricides noted that major clients of the firm include Bristol-Myers Squibb.

"Mr. Mader is uniquely qualified to ensure delivery of this complex laboratory and cGMP manufacturing suite project for us," said company chairman and president, Anil R. Diwan.

"He has extensive experience in working with various engineering and construction firms and ensuring detailed attention to critical aspects of the project."

Prior to founding MPH, Mader was the senior capital project manager at Bristol-Myers in Wallingford, Connnecticut.

NanoViricides' cGMP pilot plant is being designed to produce sufficient quantities of the drugs needed for human clinical trials testing various nanoviricide drug candidates as they advance into the clinical pipeline.

First off, the drug maker is focused on advancing its FluCide drug candidates through the regulatory process. The company has already designed the toxicology and safety pharmacology studies for the IND submission and the first-in-human clinical trials of its FluCide investigational anti-flu product.

It is now conducting further studies that are necessary before producing large batches for the safety and toxicology studies. The injectable anti-flu drug, NV-INF-1 is intended for use in hospitalized patients with the flu, and the company believes it could receive an orphan drug classification for use in immuno-compromised patients.

The company has also developed an oral anti flu drug candidate, NV-INF-2, which it has said may be the "first ever nanomedicine drug of any kind that is active when administered orally."

In October, it said that recent findings showed that its oral FluCide drug is “at least 10 times superior” to oral oseltamivir, or Tamiflu, in protecting the lungs of mice with a lethal H3N2 flu virus.

The drug is being developed for out-patient flu cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers.

Once the new facility is complete, the company said it will be able to produce sufficiently large batches of its oral anti-flu drug for further development. As the company develops data for an IND submission for its two flu candidates, it will be required to produce the drugs under cGMP conditions.

The company added that it also plans to pursue human clinical trials in countries other than the USA, which may not require the drugs to be manufactured in a registered cGMP facility.

Both the oral and injectable versions of the drug have shown "high efficacy" in preclinical animal trials, against two different influenza A strains tested.

NanoViricides said in its statement: "The company believes that these drugs will be effective against most if not all types of influenza viruses, including seasonal, epidemic, novel strains, and bird flu. In addition, both of these drugs have shown extremely good safety profile in limited animal studies."

As of September 30, the company had around $12.93 million in cash and equivalents, and around $438,000 in prepaid expenses.

Benitec Biopharma makes breakthrough in gene silencing to treat muscular dystrophy

Mon, 03 Dec 2012 14:40:00 +1100

Benitec Biopharma (ASX:BLT) research on muscular dystrophy shows encouraging in-vitro results via gene silencing.

The research targets the silencing of a gene (PABPN1), the mutant form of which causes the disease.

Data collected supports the development of a vector for combined silencing of the mutant gene by ddRNAi and replacement with a normal gene.

The data confirms that the delivery of a unique multi-shRNA cassette, Pabparna, to cells expressing the target gene is highly effective at silencing the target gene in those cells, reducing the expression levels to around 10%.

If achieved in vivo, this level of silencing by the clinical candidate is likely to result in significant improvement of the muscle disease, currently untreatable.

The researchers expect the optimal therapeutic to be based on both suppression of the target mutant gene and the replacement with a healthy gene.

Successful results at the stage of in vivo testing will be crucial to committing to advance the program into the clinic.

The program is being collaborated with Professor George Dickson from the Royal Holloway, University of London, and Dr Capucine Trollet from the Institut de Myologie.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Apollo Consolidated to test northern extension of WA gold system

Fri, 23 Nov 2012 15:50:00 +1100

Apollo Consolidated (ASX: AOP) will soon start follow-up reverse circulation drilling focusing on the northern extensions of the open Bombora gold system in Western Australia.

The initial six hole program will focus on tracking the broad Bombora zone of anomalism northwards into an area of promising structural complication.

This has the potential to locate additional strongly mineralised positions within the northern extensions of the system.

Reverse circulation drilling earlier this year in the central portion of the Bombora zone returned several very significant gold intercepts confirming that the prospect area had the potential to deliver high-grade mineralisation.

Significant results included:

-    42 metres at 7.75 grams per tonne(g/t) Au including 2 metres at 22.39g/t gold and 3 metres at 65.21g/t gold;
-    22 metres at 2.80g/t gold including 2 metres at 13.41g/t gold and 8 metres at 3.40g/t gold; and
-    1 metres at 15.69g/t gold and 4 metres at 4.76g/t gold.

Aeromagnetic imagery in the Bombora area suggests that high-grade shoots are controlled by the intersection points between NE trending cross structures and the north south mineralised zone.

The untested area to the north of the existing drilling is interpreted to be cut by several strong NE structures and this area is the focus of the current program.

All drillholes on the northernmost previous traverse intersected disseminated sulphide mineralisation, with intercepts to 8 metres at 2.28g/t gold and wide anomalous zones to 49 metres
at 0.57g/t Au indicating the zone is well mineralised in this area.

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Heartware International breaks into U.S. market with heart assist device

Thu, 22 Nov 2012 08:50:00 +1100

HeartWare International (ASX: HIN, NASDAQ: HTWR) has received approval from the U.S. Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.

The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.

Significantly, this is the first full-support, miniaturised ventricular assist device approved in U.S.

HeartWare is poised to begin commercial rollout of the system immediately, first facilitating broad use by the 50 U.S. hospitals that participated in the clinical studies, and then with training and expansion to additional U.S. hospitals.

The FDA’s Circulatory System Devices Advisory Committee earlier this year voted 9 to 2 that the benefits outweigh the risks for the use of the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.

The HeartWare® System is currently the leading ventricular assist device implanted in patients outside of the U.S., having received CE Marking in the European Union in 2009 and Australian Therapeutic Goods Administration approval in 2011.

Today more than 2,500 advanced heart failure patients globally have received the HVAD® pump.

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