OncoSil Medical commences Pivotal Clinical Trial

THE PHARMACY: OncoSil Medical (ASX: OSL) has commenced its Pivotal
Clinical Trial for its OncoSil™ localised radiation therapy for the
treatment of pancreatic cancer.

The commencement of the trial involves a submission to its lead
Australian site’s Ethics Committee for review/approval to commence
The company said the trial has the potential to be a Global Registration Study.

OncoSil Medical considers the trial to be a major milestone and
achievement in the company’s development pathway to commercialise
OncoSil™ as a viable treatment option for pancreatic cancer patients in
global markets.

The clinical trial for OncoSil™ will enrol 150 patients across 20 trial
sites and will compare patients receiving standard-of-care (for
inoperable pancreatic cancer, this is chemotherapy treatment) with
patients receiving standard-of-care plus OncoSil™ treatment, in a
randomized and controlled fashion.

150 patients will be randomized, of which 100 subjects will receive
OncoSil™ plus chemotherapy and 50 patients will receive chemotherapy

If positive, data generated by the trial may facilitate the
commercialisation of OncoSil™, including in the US, the world’s largest
health care market.

OncoSil Medical explained OncoSil™ is classified by regulators as a class III medical device and is not a drug.

“In drug development the human studies are undertaken as phase I, phase
II and phase III studies,” the company said in it ASX announcement.

“In medical device development they are undertaken as pilot and pivotal/registration studies.

“Thus medical devices require less clinical trial work for approval,
less funding required and faster time to approval when compared to drug

The company indicated it plans to roll-out the trial in Australia, in
parallel with trial sites in the UK, Belgium, Singapore and then the US.

Its initial focus will be to engage hospitals as trial sites, followed
by patient recruitment and then the commencement of dosing patients
under the trial.

OncoSil Medical is also finalising preparations for an Investigational
Device Exemption (IDE) submission for OncoSil™ with the US Food and Drug
Administration (FDA).

The company said the submission of an IDE is a key step forward along
its regulatory pathway for OncoSil™ claiming a successful study under an
IDE will allow OncoSil™ to also be commercialised in the US.