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  • OncoSil Medical Finalises Manufacturing For Pancreatic Cancer Device 0 comments
    Jul 16, 2014 8:14 PM

    OncoSil Medical (ASX:OSL) has taken a key step forward in commercialising its OncoSil™ localised radiation therapy treatment for pancreatic cancer with the revalidation of its manufacturing process.

    The work with German manufacturing partner Eckert & Ziegler ensures that the company is ready to supply OncoSil™ for the pivotal clinical trial and to meet future scalable sales.

    In addition, the manufacturing supply chain has also been established with OncoSil securing sufficient supplies of the raw materials and intermediates required to manufacture the product for the pivotal clinical trial globally.

    OncoSil also noted the successful commissioning and re-validation of its manufacturing process and quality system would support both the CE Mark audit and the U.S. Investigational Device Exemption (NYSE:IDE) submission.

    Securing the CE Mark would allow sales of OncoSil™ from its manufacturing site in Germany to the European Union while the IDE is the first step to securing U.S. Food and Drug Administration commercial approval under a Premarket Approval.

    "We are extremely pleased to report that the manufacturing revalidation which will facilitate the production of OncoSil™ for use in its Pivotal Clinical Trial and also for future sales as part of the CE Mark process has now been completed," chief executive officer Dr. Neil Frazer said.

    "This represents a major component of the trial process, as it ensures we have sufficient, quality product to meet the demands of our trial participants at various locations across the globe."

    The manufacturing process review had involved revalidation and requalification of facilities and work previously completed.

    This confirmed that the manufacturing and quality systems are of a standard that will support manufacture of OncoSil™ for the trial and also for future commercial use.

    OncoSil Pivotal Clinical Trial

    OncoSil commenced its Pivotal Clinical Trial in March is a major milestone in the company's development pathway to commercialise OncoSil™ as a viable treatment option for pancreatic cancer patients in global markets.

    This will enrol 150 patients across up to 20 trial sites.

    It will compare patients receiving standard-of-care (for pancreatic cancer it is chemotherapy treatment) with patients receiving standard-of-care plus OncoSil™ treatment, in a randomized and controlled fashion.

    Patients will be randomised with 100 subjects to receive OncoSil™ plus chemotherapy while 50 patients will receive chemotherapy alone.

    The company was yesterday awarded ethics approval for the Australian hospital sites proposed for the trial.

    If positive, data generated by the trial may facilitate the commercialisation of OncoSil™, including in the U.S., which is the world's largest health care market.

    The trial also has the potential to be a Global Registration Study.

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

    This has been proven to kill tumour cells, and provides the major benefit of reducing systemic bodily exposure to radiation.

    Given that it is a class III medical device and not a drug, OncoSil's development studies are undertaken as pilot and pivotal/registration studies that require less clinical trial work for approval, less funding and a faster time to approval compared to drug development.

    Pancreatic Cancer

    Pancreatic cancer is a devastating disease with a high mortality rate and treatment 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.

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

    Analysis

    With the revalidation of its manufacturing process for the clinical trial and future commercialisation, OncoSil is making strides towards commercialising its OncoSil™ radiation therapy treatment for pancreatic cancer.

    This facilitates its production for use in the pivotal clinical trial and future sales orders globally.

    In addition, securing sufficient supplies for its manufacture also ensures that the company will have enough product to meet the demands of its pivotal clinical trial.

    Along with yesterday's announcement of the receipt of ethics approval in Australia, OncoSil is developing and meeting significant milestones.

    Upcoming newsflow and price catalysts for OSL include bringing the first group of trial hospitals on-line.

    Additional catalysts include the submission of an Investigational Device Exemption in the US for OncoSil, and proof of concept in animal models for its OncoCal injectable "liquid radiation" product, both later this year.

    This will be followed by full patient accrual for the ONC-301 Pivotal Study as well as CE Mark registration in the first half of 2015.

    Proactive Investors anticipates a valuation for OSL of between $0.20-$0.30, within six to nine months.

    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.

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