OncoSil Medical Ltd (ASX:OSL) has completed a key step towards commercial sales of OncoSilTM, a treatment for pancreatic cancer.
This involved the successful completion of a supply chain validation process including the first radioactive calibration delivery of OncosilTM to a Sydney hospital.
The company plans to undertake a global clinical study of OncoSilTM, known as the OncoPac-1 study.
David James, head of manufacturing, commented: “We are delighted with the safe and successful validation shipment of the dose to a typical clinical site as it demonstrates that we are prepared for the commencement of OncoPac-1 and commercialisation.
“It further shows that the staff, procedures, and commercial partners that the company have assembled are accomplished at manufacturing and distributing the OncoSil product.”
U.S. market entry
The U.S. Food and Drug Administration has granted OncoSil the clearance it needs to start testing its medical device for the treatment of pancreatic cancer in U.S. patients.
The OncoPac-1 study is a major set piece for OncoSil, designed to secure U.S. market access and drive clinical adoption elsewhere.
The study will start with a 20 patient safety run-in phase, before opening up to a randomised, open-label, pivotal trial targeting 300 patients.
CE Mark
A CE Mark application for regulatory approval to commercially sell the OncoSilTM device in the European Union and other non-US markets is under review with commercial launch planned for 2H16, subject to approval.
OncoSil remains confident of near-term approval to start selling OncoSil™ in Europe. The CE Mark, if attained, will provide both further technology validation and modest revenues.
European centres have been invited to participate in OncoPac-1, enabling practitioners to try the product under the guidance of a controlled protocol and be participants in the academic exercise.
If successful, OncoPac-1 could be a landmark study for both OncoSil and patients globally.
Analysis
The manufacturing, supply chain validation and delivery to clinical and commercial centres of the OncoSil product is a key step to commercial sales and the treatment of patients in the OncoPac-1 study.
As OncoSil continues to complete such milestones, it gets closer to commercial revenues.
The company had $13.3 million in cash at 30 June 2016 which will likely allow the company to fund the commencement of the trial.
OncoSil has been receiving strong broker attention recently, as the company moves closer to commercial revenue.
OncoSil last traded at $0.14 with broker price targets ranging from $0.33 to $0.80.
OSL Price at posting:
14.0¢ Sentiment: Buy Disclosure: Held
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