OncoSil Medical’s (ASX: OSL) manufacture of its pancreatic cancer treatment medical device OncoSil™ for use in the Pivotal Trial is currently being audited and validated as part of its CE Mark submission.
Obtaining a CE Mark is essential for marketing medical devices in the European Union and will also allow marketing to begin in Australia, Canada and Singapore.
The company has made significant progress recently towards commercialising OncoSil™ with a submission to its lead Australian site’s Ethics Committee for review/approval to commence recruitment for the Pivotal Clinical Trial.
It is anticipated that the first patient in the trial will be recruited in Australia, and this will be expanded, in parallel, with sites in the UK and Belgium.
OncoSil Medical is also in the final stages of submission to the US Food & Drug Administration (FDA) for an Investigational Device Exemption.
This is a key step in the regulatory pathway for OncoSil™, as a successful trial under an IDE will allow OncoSil™ to be commercialised in the U.S. market.
If positive, data generated by the trial may facilitate the commercialisation of OncoSil™, including in the US, the world’s largest health care market.
The lead site in the US arm of the trial will be at the world-renowned Johns Hopkins University.
Anticipated Clinical Trial Timelines
It is anticipated that the majority of the 150 patients will be enrolled on to the trial within 12 months of the first patient enrolment.
An interim analysis will be conducted at approximately 12 months from date of commencement, when six months have elapsed since the first 30 patients entered the study.
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; and
- 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.
Analysis
OncoSil Medical continues to progress commercialisation of its pancreatic cancer treatment medical device OncoSil™, which would allow it to meet the requirements of a largely unmet market that is projected to exceed $1.2 billion by 2015.
Share price catalysts ahead include:
- Securing ethics approval to begin patient enrolment for its Pivotal Clinical Trial;
- A successful U.S. Investigational Device Exemption submission; and
- Receiving CE Mark approval.
Proactive Investors maintains its valuation for OSL of between $0.20-$0.30, within six to nine months.
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