OncoSil Medical (ASX: OSL) is taking a milestone step towards commercialising its pancreatic cancer treatment medical device OncoSil™ with the start of its Pivotal Clinical Trial.
This involves a submission to its lead Australian site's Ethics Committee for review/approval to commence recruitment.
Notably, as OncoSil™ is classified by regulators as a class III medical device and not a drug, it will undergo pilot and pivotal/registration studies rather than the three phase study needed for drug development.
This requires less clinical trial work for approval, which in turn lowers funding required and increases the time to approval.
The Trial, which could develop into a Global Registration Study, will 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 randomized and controlled fashion. 100 random subjects will receive OncoSil™ plus chemotherapy while the remaining 50 patients will receive chemotherapy alone.
If positive, data generated by the trial may facilitate the commercialisation of OncoSil™, including in the U.S, the world's largest health care market.
The company plans to roll-out the trial in Australia, in parallel with trial sites in the UK, Belgium, Singapore and then the U.S. Engaging hospitals as trial sites will be a key initial focus, followed by patient recruitment and then the commencement of dosing patients under the trial.
It is also finalising preparations for its Investigational Device Exemption submission for OncoSil™ with the U.S. Food and Drug Administration.
This is another key step in the regulatory pathway for OncoSil™ that will allow it to be commercialised following a successful study.
"We are delighted to embark on the Pivotal Clinical Trial for OncoSil™, which is a significant event in the company's journey to secure the product's regulatory approval and eventual commercialisation," chief executive officer Dr. Neil Frazer said.
"Our goal of being able to provide a viable treatment option for pancreatic cancer patients is a now step closer to be realised, and we look forward to providing details of the trial's progress in due course. I would also like to acknowledge the outstanding work of all involved in the OncoSil Medical team in achieving this milestone."
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.
Under the trial design, interim analysis may be done under advice from the trial's biostatisticians and regulatory authorities including U.S. FDA, to help ensure the trial is progressing in-line with its objectives.
Safety of the device is an important assessment point, and a safety analysis will be conducted on a regular basis to determine if the trial should continue.
Overall Survival (OS) will be the key endpoint of the trial. A clinically meaningful improvement in OS of 30% or more (compared to standard-of-care) and pain scores/quality of life will represent potentially registrable endpoints.
Interim analysis will be done under advice from our biostatisticians, and will provide the ultimate in flexibility with a gold standard open label RCT for adjusting patient numbers.
- Interim analysis will be conducted once 30 patients have completed at least six months on study;
- >15% or greater improvement in Progression Free Survival (NYSE:PFS) for the OncoSil™ arm will confirm a positive trend;
- Overall survival(OS) remains the key endpoint;
- Safety of the device will be an important measuring point to allow study to continue;
- Clinically meaningful improvement in OS (>30% improvement vs SOC) and pain scores/quality of life remain registrable endpoints
In a previous pilot study of 17 pancreatic cancer patients using OncoSil there was a 81% OS improvement or 4.6month median OS benefit vs SOC(gemcitabine chemotherapy + OncoSil 10.3m median OS vs 5.7month median OS with gemcitabine chemotherapy alone).
OncoSil is developing OncoSil™ as an implantable device that emits radiation directly into the pancreatic tumour, and the pain conducting nerves surrounding it.
Radiation therapy, such as that supplied by OncoSil™ is known to kill tumour cells, and OncoSil™ 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.
Localised radiation technology also seeks to protect healthy cells from the devastating side effects of traditional radiotherapy and chemotherapy, which cause damage throughout the body.
This will reduce, and possible eliminate, some of the dreaded side effects such as hair loss, severe fatigue, and skin problems.
There is a major unmet clinical need for pancreatic cancer treatments, with 280,000+ pancreatic cancer incidence yearly world-wide, with around 45,000 new patients diagnosed with pancreatic cancer in the U.S. each year.
The median survival after diagnosis is only five months. Surgery is only feasible in 20% of patients, and chemotherapeutic treatments work in only around 15% of patients.
The world market for pancreatic drugs is projected to exceed $1.2 billion by 2015.
OncoSil believes that new implantable radiotherapies such as OncoSil™ may have the opportunity to treat the disease and the debilitating pain associated with it - and fill a major unmet medical need in pancreatic cancer treatment.
The start of the Pivotal Clinical Trial is a milestone for OncoSil, placing it firmly on the road towards commercialising its pancreatic cancer treatment medical device OncoSil™.
That this could lead to a Global Registration Study is a further positive, allowing the company to complete the studies it needs before bringing the device to a largely unmet market that is projected to exceed $1.2 billion by 2015.
To top it off, the company is already developing its next generation localised radiation technology, OncoCal, which involves the injection of radioactive phosphorus directly into the tumour mass.
This can be used in conjunction with OncoSil™ and existing cancer treatments.
Proactive Investors maintains its valuation for OSL of between $0.20-$0.30, within six to nine months.
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