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OncoSil Medical ramps up for upcoming commercialisation of OncoSil™

Last updated: 20:00 10 Nov 2014 AEDT, First published: 21:00 10 Nov 2014 AEDT

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OncoSil Medical (ASX:OSL) has commenced Australian trials for OncoSil which is an implantable nuclear medical device developed for lower cost treatment of pancreatic cancer. 

Apart from these trials, there is also the roll-out of the OncoSil™ Pivotal Clinical Trial with the US FDA and also the upcoming commercialisation with the CE Mark in the EU to look forward to for the Company.

The technology has already proven its efficacy in earlier, limited trials and is inherently safe, effective, and is well tolerated. 

Clinical data to date included ten clinical trial results. Seventeen locally advanced pancreatic cancer patients were treated in single arm study, and OncoSil reported significant anti-cancer activity, with a disease control rate of 82%. This included four partial responses, ten stable disease responses and three progressive disease responses. The average reduction in pain was noted at 35% -, with a maximum reduction of 69% between weeks 8 and 11 following implant.

The median progression free survival period was 121 days, median overall survival was 309 days, or 10+ months, and compared with a typical 5.7 months with gemcitabine alone.


Recent developmental updates


Recent development has been substantial as the Company continues to advance the clinical development pathway for OncoSil which is its lead product candidate.  The core focus is on developing the OncoSil product into a new and commercially available option for the treatment of pancreatic cancer, and then marketing the product on a global basis.  Management report that significant progress has been made in pursuit of this goal. 

The efforts of the OncoSil Medical team have been geared towards the initiation of the Pivotal Clinical Trial for OncoSil. This formally commenced in March 2014, and was a landmark milestone for the Company. 

The commencement of the Trial involved a submission to the Ethics Committee of the lead Australian hospital site for review and approval to commence patient recruitment into the Trial, which has now been granted. 

On 16 July 2014, the Company reported the OncoSil manufacturing process had been revalidated for its localised radiation therapy treatment for pancreatic cancer to be used in its Pivotal Clinical Trial, and in preparation for sales of the product under the (European) CE mark process. 

The Company completed a successful commissioning and re-validation of its manufacturing process and quality system in conjunction with its German manufacturing partner, Eckert & Ziegler. This will ensure a ready supply of OncoSil for the Pivotal Clinical Trial, and to meet future scalable manufacturing demands. 

The Ethics Approval is a significant advancement in the product's trial process, and is the culmination of a detailed ethics submission process with its Hospital Ethics Committee.


Launch of Australian OncoSil trial as precursor to global trial roll-out

The Trial for OncoSil proposes to enrol 150 patients across 20 trial sites. It will compare patients receiving standard-of-care (for inoperable pancreatic cancer this includes chemotherapy treatment) with patients receiving standard-of-care plus OncoSil treatment, in a randomised and controlled fashion. 

Patients will be randomised on a 2:1 ratio. This means that for every 2 subjects who will receive OncoSil plus chemotherapy, 1 patient will receive chemotherapy alone.  The 150 patients that are currently planned for this pivotal trial will later be subject to regulatory review from the FDA.


Australian trial to take 12 -18 months


Once enrolment is complete, it is expected to take 12-18 months to evaluate patients and determine their progress. 

The key study measures will be; 
· Overall Survival (time until patients die from their disease) 
· Progression Free Survival (time before the cancer has been shown to progress) 
· Quality of life 
· Pain relief 

A key goal of the trial is also to have results published in a prestigious medical journal, with a view to influencing the standard-of-care (the current accepted best practice treatment) provided to pancreatic cancer patients globally. 

Positive, data generated by the Trial may facilitate the commercialisation of OncoSil, including in the US, which is the world's largest health care market. The main focus of the Pivotal Trial is for FDA approval and for the results to be published in a prestigious medical journal. The Johns Hopkins in Baltimore under Prof. Joseph Herman is planned for the role of lead investigator. 

The Company plans to roll-out the trial in Australia, in parallel with trial sites in the UK, Belgium, US and then Singapore. Engaging hospitals as trial sites is a key initial focus, followed by patient recruitment and then the commencement of dosing patients under the trial. 


Board strengthened to assist with development of OncoSil

In September of 2014 Dr Roger Aston was appointed Executive Chairman and Martin Rogers became Non-Executive Director. Current CEO Dr Neil Frazer moved from CEO to newly created position of Chief Medical Officer, and remained on the board as an Executive Director.  


Other Clinical Activity includes U.S. FDA submission 

The Company also continued to make preparations for an Investigational Device Exemption application (IDE) submission for OncoSil to the US Food and Drug Administration (FDA), and expects to submit an IDE in the near future. An IDE submission would represent a significant step in the regulatory pathway for OncoSil, and is the first step towards securing the FDA's commercial approval for OncoSil under a Premarket Approval (PMA).

In February 2014, the Company announced a new development program for a next generation delivery platform for its localised radiation technology for the treatment of solid tumours. The development program is for a treatment called OncoCal, which is an injectable source of P-32 (radioactive phosphorus). It represents an innovation in the delivery of safer local radiation therapy for solid tumours and it is anticipated that it may complement OncoSil.


September Quarterly Results
 
OncoSil reported cash outlays of $1,112,000 on research and development, and a very modest outlay of $248,000 on administration. No revenue was reported and total cash burn was $1,590,000. Cash held at the end of the quarter was a substantial $5.44 million.


Analysis

There are highly commercially successful products using radiation therapy devices. These include Algeta, which developed Xofigo that is an alpha particle emitting device for treatment of cancer. Algeta raised US$41 million, and went public in March of 2007. In December of 2013 Bayer purchased Algeta for US$2.9 billion after maintaining a close collaboration with the Company.

Medical devices typically take 5 years to develop and trial, and are relatively inexpensive when compared with the 10 year long development cost of drugs that serve the same purpose.  

Over 280,000 new cases of pancreatic cancer are reported each year and current treatment includes surgery, chemotherapy, radiotherapy, and immune therapy. Cost of treatment can exceed $60,000 per year and survival rates are only 7% after treatment of up to 5 years. 

The global market for pancreatic drugs is estimated to reach $1.2 billion in 2015, and represents a major opportunity for OncoSil if trials are successful.

Major catalysts for OncoSil are expected to occur in the second half of 2015 with potential commercialisation in the European Union, Canada, and Australia.  

Successful trials and launch of OncoSil may see the Company follow in the footsteps of Algeta.  


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