OncoSil Medical (ASX: OSL) has successfully completed a gap analysis assessment of the regulatory requirements required to submit an Investigational Device Exemption for its pancreatic cancer treatment medical device OncoSil™.
This found the company would not require a second pre-IDE meeting. It was also asked to develop a full protocol for the device registration study and is in the final stages of completing that request.
Documentation to support OncoSil's regulatory submissions to the U.S. Food and Drug Administration is being compiled and the company is optimistic that the process will be completed in the current quarter.
Completing the regulatory and ethics submissions is a critical part of getting the clinical trial moving and the company is working with its experts towards moving this process forward.
The clinical study design to allow evaluation of OncoSil™ in comparison with the current standard of care is in final review.
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.
Notably, the company is seeking to register OncoSil™ as a medical device in all major markets as they have a fraction of the development cost compared to drugs and are faster to register, making for a better return on investment.
Localised radiation therapy is also inherently safe, effective and well tolerated.
The IDE submission to the FDA is a crucial part of the company's strategy and business plan that represents not just potential commercial approval for OncoSil™ but also validation from the broad medical community for its use.
The IDE involves submission of manufacturing data, a protocol, an investigators brochure and any clinical safety and efficacy data generated to date, to permit the pivotal clinical study to be conducted in the U.S.
As part of the FDA Regulatory Pathway report, OncoSil and Emergo Group will determine if a simple reference device comparison approach (a 510(k) submission) or a Pre Marketing Authorisation (NYSEARCA:PMA) is appropriate.
If OncoSil's IDE is approved, it will allow the company to recruit patients into the pivotal pancreatic cancer study in the U.S.
The global pivotal clinical study predicted to commence this year is being designed to provide data on the safety and efficacy of the device, in a randomised and controlled fashion.
If positive, the data generated by the clinical study will facilitate commercialisation of OncoSil™.
OncoSil has completed four clinical studies, two of which were for the treatment of pancreatic cancer.
These have demonstrated that treatment with OncoSil™ was:
- Well tolerated;
- Easy to administer;
- Stabilised the patient's disease in most cases; and
- Provided good pain relief.
The results have prompted the company to move forward with a clinical study with 150 patients, to be conducted globally in 20 centres in Australasia, Europe, United States and Singapore.
This study, scheduled to commence first quarter this year, will compare patients getting standard-of-care with patients getting standard-of-care and OncoSil™ treatment. The key study measures will be:
- Patient survival;
- Time before the cancer starts to progress;
- Quality of life; and
- Pain relief.
OncoSil Medical is consulting with key experts in the area, as well as regulatory authorities in Europe, Australia and the US, to ensure that the study will meet the needs of the Company plus the needs of patients.
It is anticipated that the majority of patients for the key study will be enrolled within 12 months after first patient enrolment and it is expected to take around a further twelve to eighteen months to evaluate patients and to determine their progress.
$1.2 billion market by 2015
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 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 completion of the gap analysis paves the way for OncoSil to submit an Investigational Device Exemption for its pancreatic cancer treatment medical device and represents a firm step towards commercialisation.
There is major unmet clinical need for OncoSil's localised radiation therapy potential solution for pancreatic cancer.
In addition, medical devices require significantly less funding and the time required to undertake a registration study with faster approval compared to drugs. This is likely to result in better gross margins.
On our preliminary analysis, Proactive Investors estimates that OncoSil has an intrinsic worth of between $0.20-$0.30 within six to nine months.
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