News: OncoSil Medical to advance global registration plan

OncoSil Medical (ASX:OSL) expects to secure CE Mark and U.S. Food and Drug Administration Investigational Device Exemption approval for OncoSil™ in pancreatic cancer in the second half of 2015.

It will pursue a global registration program in pancreatic cancer following a detailed strategic clinical and regulatory review by new managing director Daniel Kenny.

Securing the CE Mark is a key milestone for the commercialisation and development of the implantable nuclear medical device given that it is required by regulators to sell OncoSil™ in the European Union.
   
It will also facilitate its commercialisation in Australia, New Zealand and Canada.

An IDE submission represents a significant formal step in the FDA’s commercial approvals process for OncoSil™ under a Premarket Approval.

A key component of the IDE submission is the conduct of the Pivotal Study, the design of which will be comprehensively reworked following the recently completed clinical and regulatory review.

The company will provide further updates on the new design before the end of the second quarter and will start active patient recruitment in the third quarter of this year.

“Following our strategic review, the company is now better positioned to secure both the CE Mark and U.S. FDA IDE this year,” Kenny said.

“Our Pivotal Study will now commence active recruitment in CY3Q following redesign based on comprehensive expert feedback including scientific advice from regulatory authorities.”


OncoSil™

OncoSil™ is an implantable device that emits radiation directly into a pancreatic tumour and delivers therapy locally for up to three months.

The device is inserted directly into the centre of the tumour using well established technology.. Radiation therapy, such as that supplied by OncoSil™, is known to kill tumour cells.

It is classed by regulators as a Class III medical device, which typically require less clinical trial work for approval, less funding and have a faster time to approval when compared to drug development.

In drug development human studies are typically undertaken as phase I, phase II and phase III studies. In medical device development studies are undertaken as pilot and pivotal/registration studies.


Pancreatic cancer and the OncoSil™ opportunity

Pancreatic cancer is a devastating disease and treatment remains a challenge.

In the U.S., over 40,000 patients are diagnosed with pancreatic cancer each year.

Treatment of pancreatic cancer remains a major unmet medical need, and the median survival after diagnosis is only five months. Surgery is only feasible in 20% of patients, and chemotherapeutic treatments work in only around 15% of patients.

Radiation therapy is used, but has systemic side effects in an already sick patient population.

Localised radiation therapy, including new implantable radiotherapies such as OncoSil™, may offer a potential treatment option without systemic side effects.


Catalyst

The next catalyst will be the announcement of an approved protocol, which will include the location of the centres, sample sizes and recruitment timeline.


New Leadership

New managing director and chief executive officer Daniel Kenny has almost 30 years’ experience in the global pharmaceutical industry, including senior roles with Roche, Allergan and Baxter.

This includes more than 10 years of experience in clinical research in the fields of ophthalmology and HIV/AIDS prior to joining the pharmaceutical industry.

Prior to joining OncoSil, he as chief commercial officer and vice president business development at major French biopharmaceutical company, ABIVAX, where he was responsible for the development and implementation of the commercial and business development strategy.

He was also previously global franchise head at Baxter Vaccines, where he successfully reinvigorated the base commercial business and significantly exceeded the business’s financial plan in each of the three years of his tenure.

Kenny was also vice president Baxter BioScience, EMEA where he was responsible for the marketing and key business programs in support of regional sales exceeding $1.9 billion.

In addition, he was a global lifecycle leader for Roaccutane with Roche, with responsibility for global strategic marketing and business development activities of Roaccutane, an acne treatment product, which generated sales in excess of 1.1 billion Swiss francs (A$1.32 billion) in 2002.

   
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