OSL – Oncosil Medical | Aussie Stock Forums

latest ASX announcement:
Is there anyone else out there????
Suite 1802, Level 18, 15 Castlereagh Street Sydney NSW 2000 AUSTRALIA
TELEPHONE +61 2 9223 3344 FACSIMILE +61 2 9221 8535
WEB www.oncosil.com.au
ASX / Media Release
OncoSil Medical initiates US FDA gap analysis
● The path to initiate a pivotal clinical trial in pancreatic cancer patients will be determined by this analysis
● OncoSil™, the company’s product in development, has the potential to fill a major unmet medical need in pancreatic cancer
● There are highly successful commercialised precedents for Investigational Device Exemption (IDE) for localised radiation treatments for hepatic and prostate cancer
● The IDE, if approved, will allow OncoSil Medical to recruit patients into the pivotal pancreatic cancer study in the US
● 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
SYDNEY, 8th August, 2013 : OncoSil Medical Limited (ASX: OSL) is pleased to announce the following update on an advance in the development of its product candidate, OncoSil™. The company is initiating 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 US Food and Drug Administration (FDA).
Pancreatic cancer is a devastating disease and treatment of this cancer remains a challenge. OncoSil Medical believes that new implantable radiotherapies such as OncoSil™ may have the opportunity to treat the disease and the debilitating pain associated with it. The United States has over 40,000 patients diagnosed annually with pancreatic cancer, and is the largest single market for healthcare in the world. Treatment of pancreatic cancer remains a major unmet medical need, as the median survival after diagnosis is only 5 months. Surgery is only feasible in 20% of patients, and chemotherapeutic treatments only work in around 15% of patients. Radiation therapy is used, but has systemic side effects in an already sick patient population. Localised radiation therapy supplied by OncoSil™ offers a potential treatment without systemic side effects.
OncoSil Medical 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
Suite 1802, Level 18, 15 Castlereagh Street Sydney NSW 2000 AUSTRALIA
TELEPHONE +61 2 9223 3344 FACSIMILE +61 2 9221 8535
WEB www.oncosil.com.au
months. The device is inserted directly into the centre of the tumour using well established technology in a short 15-30 minute procedure.
OncoSil Medical has engaged regulatory consultancy Emergo Group as experts to support a US FDA IDE submission. 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™.
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 Medical 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 randomized and controlled fashion. If positive, the data generated by the clinical study will facilitate commercialization of OncoSil™.
Commenting on the strategic approach, Dr. Neil Frazer, CEO of OncoSil Medical noted “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 commercialization of the product. We welcome our relationship with Emergo Group, a well-established consulting organization with expertise in medical device regulatory compliance, to conduct the analysis and support our application for an IDE.”
Emergo Group is also providing expert support for the regulatory process around submission and potential commercialization of OncoSil™ in Europe.
Dr Neil Frazer
Chief Executive Officer and Managing Director
T +61 2 9223 3344
Twitter: @Dr_Neil_Frazer

I hope this will spark some interest.

Some interesting points:

This is a medical device, and not a drug, as such FDA approval should be easier and faster than a new drug.

Tests done to date, admittedly on a very small sample, suggest that survival rate is approx double the current gold standard treatment.

Treatment is currently for Pancreatic CA. There is no reason why the same technique could not be used in other radiation sensitive cancers in other locations where a scope can get you to close proximity. (Think Sirts for pancreatic cancer).

Have a close look at this one.

The only question is how much money do we need for the trials, and more importantly the navigation of the red tape leading up to the approval of the trials, and when will it need to be raised?

Anybody with expertise in this area who could give me any idea as to how much we need, I would love your input.

Thanks Jewels

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