OncoSil Medical Ltd: IDE Approval from the U.S. Food and Drug...

OncoSil Medical Ltd: IDE Approval from the U.S. Food and Drug Administration
Tuesday, August 02, 2016 by Proactive Investors



http://www.*.com.au/genera//img/companies/news/oncosil_daniel_kenny_new_358_57a0050513276.jpg
Daniel Kenny, CEO, OncoSil Medical Ltd

OncoSil Medical Ltd (ASX:OSL) has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA).

The company will now initiate a pivotal clinical investigation for OncoSil™ for the treatment of eligible subjects with pancreatic cancer.

OncoSil is a late stage medical devices company focused on localised treatments for subjects with pancreatic and liver cancer.

Daniel Kenny, CEO for OncoSil, commented:

“We are delighted to receive FDA approval for the IDE which is a significant milestone in our regulatory pathway and a validation of our product and supporting processes to commence this important clinical study.

"This achievement in only eight months from submission is a testament to the quality of the work that our dedicated and highly experienced team has undertaken and I would like to acknowledge and thank them.

“We have also been active in a number of preparatory steps to support the initiation of the OncoPac-1 Study.

"We have been working to secure leading Principal Investigators, key hospitals and centres in the United States, Europe and Australia.

“The IDE Approval is beneficial in supporting our ongoing CE mark application and we remain confident of obtaining our CE Mark in the near term.

"Our clinical team continues to advance the engagement with leading clinicians and centres in Europe, with the aim of treating both Study subjects and commercial cases, once we achieve our CE mark.”

OncoPac-1 U.S and International Clinical Study

As previously advised, the company had filed an IDE Amendment with the FDA for its planned global clinical study of OncoSil™ for the treatment of pancreatic cancer (OncoPac-1).

This followed an intensive eight month process of submissions and interactions with the FDA.

The company has received notification from the FDA that the IDE Amendment submission has been approved thereby clearing the way for the company to initiate its planned global clinical study, OncoPac-1.

The key details of OncoPac-1 study are as follows:

- OncoPac-1 is a global, multi-centre, randomised, open label, pivotal efficacy and safety study of OncoSil™. The Study is intended to include up to 30 centres in the United States and other international markets including the United Kingdom, Europe and Australia;

- In this pivotal study, a total of 300 subjects will be recruited with locally advanced unresectable adenocarcinoma of the pancreas. Stage 1 of the Study consists of 20 subjects across a maximum of 5 centres in the United States. These patient data will be subject to an FDA review focused on the safety profile;

- Following the successful completion of Stage 1, eligible subjects will be randomised to either OncoSil™ plus standard chemotherapy treatment or standard chemotherapy treatment of gemcitabine or gemcitabine + nab-paclitaxel alone. In the investigational arm, OncoSil™ microparticles will be implanted intra-tumourally via endoscopic ultrasonography;

- Primary Efficacy Endpoint is Local Progression Free Survival (LPFS). Secondary Endpoints include Progression Free Survival (PFS), Overall Survival (OS), Pain Scores, Body Weight, Safety & Tolerability, and Performance Status. Quality of life measures will be studied;

- OncoPac-1 Study is expected to enrol the first subject in early 2017 and recruitment is anticipated to take approximately 2 years, with each patient to be followed until disease progression. Subjects are then followed for overall survival until death, or until the last enrolled study patient has completed 52 weeks of overall survival follow-up.