OncoSil Medical Starts U.S. FDA Gap Analysis For Pancreatic Cancer Device

Aug. 08, 2013 2:39 AM ET
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OncoSil Medical (ASX: OSL) has taken a step on the path towards commercialising the company's pancreatic cancer treatment medical device OncoSil™.

The company has now initiated a gap analysis assessment of OncoSil™, which is an important step in defining the regulatory pathway to a pre Investigation Device Exemption (IDE) meeting with the U.S. Food and Drug Administration (FDA).

OncoSil is developing OncoSil™ as an implantable device that emits radiation directly into the pancreatic tumour, and the pain conducting nerves surrounding it.

Radiation therapy, such as that supplied by OncoSil™ is known to kill tumour cells, and OncoSil™ delivers radiation therapy locally for up to three months. The device is inserted directly into the centre of the tumour using well established technology in a short 15-30 minute procedure.

Notably, the company is seeking to register OncoSil™ as medical device in all major markets as they have a fraction of the development cost compared to drugs and are faster to register, making for a better return on investment.

Localised radiation therapy is also inherently safe, effective and well tolerated.

$1.2 billion market by 2015

There is a major unmet clinical need for pancreatic cancer treatments, with 280,000+ pancreatic cancer incidence yearly world wide, with around 45,000 new patients diagnosed with pancreatic cancer in the U.S. each year.

The world market for pancreatic drugs is projected to exceed $1.2 billion by 2015.

OncoSil believes that new implantable radiotherapies such as OncoSil™ may have the opportunity to treat the disease and the debilitating pain associated with it - and fill a major unmet medical need in pancreatic cancer treatment.

OncoSil has the experience to succeed

The company has a management team with experience to guide products through the global development and regulatory process, with OncoSil appointing Dr Neil Frazer as chief executive officer recently to drive the next stage of development and potential approval of OncoSil™ device.

Dr Frazer has a background in drug development in multiple therapeutic areas which includes oncology drug development, and has been responsible for successful U.S. Food and Drug Administration applications for ten new chemical entities and over twenty applications for the line extensions of pharmaceutical drug applications.

Commenting today, Dr Frazer said, "A gap analysis, and the initiation of the pathway to an IDE, will stand us in excellent stead as we move OncoSil™ through the regulatory processes required to support commercialisation of the product.

"We welcome our relationship with Emergo Group, a well-established consulting organisation with expertise in medical device regulatory compliance, to conduct the analysis and support our application for an IDE."

The firm has extensive experience in supporting medical device submissions globally, and particularly in the US. In order to ensure an optimal submission, Emergo Group will compile an FDA Regulatory Pathway report, taking into account the company's current data for OncoSil™.

There are highly successful commercialised precedents for IDE for localised radiation treatments for hepatic and prostate cancer.

If OncoSil's IDE is approved, it will allow the company to recruit patients into the pivotal pancreatic cancer study in the U.S.

The gap analysis will review all OncoSil Medical's data generated to date on the manufacture of the OncoSil™ device to establish the regulatory path for the pre-IDE meeting.

IDE submission

The IDE involves submission of manufacturing data, a protocol, an investigators brochure and any clinical safety and efficacy data generated to date, to permit the pivotal clinical study to be conducted in the US.

As part of the FDA Regulatory Pathway report, OncoSil and Emergo Group will determine if a simple reference device comparison approach (a 510(k) submission) or a Pre Marketing Authorisation (PMA) is appropriate.

The global pivotal clinical study predicted to commence next year is being designed to provide data on the safety and efficacy of the device, in a randomised and controlled fashion.

If positive, the data generated by the clinical study will facilitate commercialisation of OncoSil™.

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