Australian Company Hopes To Begin U.S. Trial for Pancreatic Cancer Radiation Implant This Year

Australian medical device company OncoSil Medical has completed a gap analysis assessment of the regulatory requirements required to submit an Investigational Device Exemption (IDE) for its pancreatic cancer treatment medical device OncoSil. The company reported that it will not require further pre-IDE meetings before submitting the relevant paperwork to the U.S. Food and Drug Administration (FDA). An IDE categorization for OncoSil will enable the company to conduct a clinical trial for the device in the United States, which the company hopes to begin this year.

OncoSil is an implanatable device that delivers localized radiation to pancreatic tumors. Pancreatic cancer has very poor prognosis and is one of the most deadly forms of cancer with only a 6 percent 5-year survival rate, according to the American Cancer Society. The current standard of care for pancreatic cancer is to provide gemcitabine intravenous chemotherapy and possible external beam radiation, both of which do not control the tumor for long.

According to OncoSil, its device is designed to be implanted directly into the center of the tumor in a procedure that takes 15 to 30 minutes. Then, the device delivers local radiation therapy for up to three months. This, the company claims, would control the growth and spread of the tumor, as well as the pain.

Localized therapy is also a much better option for cancer patients due to the limited damage to healthy cells.

Emergo Group, which helps companies enter foreign markets, is helping OncoSil with its IDE submission. This 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 United States. Emergo will also be charged with advising whether a 510(k) or premarket approval submission will be appropriate after the clinical trial.

OncoSil has completed four clinical studies, two of which were for the treatment of pancreatic cancer. According to the company, so far the trials have demonstrated that OncoSil is well tolerated, easy to administer, stabilized the patient’s disease in most cases, and provided pain relief. These results have prompted the company to move forward with a clinical study with 150 patients, to be conducted globally in 20 centers 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.

It is anticipated that the majority of patients for this 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.

There is a major unmet clinical need for pancreatic cancer treatments, with more than 280,000 pancreatic cancer incidence yearly world wide, with around 45,000 new patients diagnosed with pancreatic cancer in the United States each year. The world market for pancreatic drugs is projected to exceed $1.2 billion by 2015.