OncoSil Medical (ASX:OSL) struck a 204% increase in revenue to $305,225 along with cash and deposits of $7 million at financial year end.
During the period, the company has continued to advance clinical development for its OncoSil™ localised radiation therapy for the treatment of pancreatic cancer.
It had in March 2014 formally commenced the Pivotal Clinical Trial, which will enrol 150 patients across 20 trial sites.
A trial site will commence in Australia, in parallel with trial sites in the UK, Belgium, US and then Singapore.
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 main focus of the Pivotal Trial is for FDA approval and for the results to be published in a prestigious medical journal.
Engaging hospitals as trial sites is a key initial focus, followed by patient recruitment and then the commencement of dosing patients under the trial.
"Whilst pleased and excited by the achievements to date, the year ahead represents an even more significant period for the company, as we embark on pancreatic cancer patient recruitment and treatment under the OncoSil™ Pivotal Clinical Trial," chairman Martin Rogers said.
"I, along with the entire OncoSil Medical team, am totally committed to the goal of providing a new treatment option for pancreatic cancer patients, and I look forward to sharing news of our progress with you in the year ahead."
Review of Operations
On 17 March, OncoSil Medical initiated its Pivotal Clinical Trial for OncoSil™ that involved a submission to its lead Australian site's Ethics Committee for review and approval to commence recruitment.
This was subsequently granted in July 2014.
The trial has the potential to be a Global Registration Study and is 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 Company has also continued to make preparations for an Investigational Device Exemption application (NYSE:IDE) submission for OncoSil™ to the US Food and Drug Administration (FDA), and expects to submit an IDE in the near future.
An IDE submission would represent a significant step in the regulatory pathway for OncoSil™, and is the first step towards securing the FDA's commercial approval for OncoSil™ under a Premarket Approval (NYSEARCA:PMA).
In February 2014, OncoSil announced a new development program for a next generation delivery platform for its localised radiation technology for the treatment of solid tumours.
OncoCal™ is an injectable source of P-32 (radioactive phosphorus) that represents an innovation in the delivery of safer local radiation therapy for solid tumours and it is anticipated that it may complement OncoSil™.
Patent coverage has also been established for OncoSil™ in multiple jurisdictions, with most recently a patent being granted in the United States in October 2013.
In August 2013 the Company initiated a gap analysis assessment of OncoSil™ with the US Food and Drug Administration as part of the regulatory development pathway for OncoSil™.
In July 2013, the Company entered into a global strategic alliance with major German radiopharmaceutical and nuclear medicine company, Eckert & Ziegler, for the manufacture of OncoSil™.
OncoSil™ Trial Pancreatic Cancer
The OncoSil™ trial seeks to enrol 150 patients across 20 trial sites. It 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 randomised and controlled fashion.
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 Company aims to roll-out the trial in Australia, in parallel with trial sites in the UK, Belgium, the Netherlands, Singapore and then the US.
It is anticipated that the majority of 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.
OncoSil Medical is well positioned to progress the pivotal clinical trial for its OncoSil™ localised radiation therapy for the treatment of pancreatic cancer.
If successful, this will facilitate the commercialisation of OncoSil™ and may lead to a Global Registration Study.
More recently, the company has revalidated the manufacturing process for the device, facilitating its production for use in the pivotal clinical trial and future sales orders globally.
It has also received ethics approval for the Australian hospital sites proposed for the trial.
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 OncoCal, both later this year.
Then in the first half of 2015, investors can look forward to full patient accrual for the ONC-301 Pivotal Study as well as CE Mark registration.
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