(MENAFN- ProactiveInvestors)
Clinical-stage Australian Lifesciences company () is on-track to commercialise OncoSil™ in the European Union.
Following the recent granted of ISO certification for OncoSil™ filing remains on schedule for the Conformité Européenne (CE) Mark approval in Q3 2015.
OncoSil™ is a localised radiation treatment for cancer and is the company's lead product candidate.
It is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.
The localised radiation therapy is inherently safe effective and well tolerated.
Commercialisation in the European Union would also facilitate sales in other major markets with the global market for Pancreatic Cancer being US$1 billion and for HCC Liver Cancer an additional US$1.4 billion.
OncoSil™ has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.
Daniel Kenny CEO commented: “I am delighted with the efforts of the regulatory and medical affairs team in securing ISO Certification in April.
"This certification is a key requirement for CE mark Approval.
"In my career I have been involved with numerous commercially successful ‘blockbuster’ products in Europe and I am very excited to now be in the forefront of potentially a new radiation treatment for the dreaded disease of pancreatic and liver cancer.”
Kenny brings almost 30 years’ experience in the global pharmaceutical industry including senior roles with Roche Allergan and Baxter.
CE Mark
will file for CE Mark in both pancreatic and primary liver cancer – hepatocellular carcinoma (HCC).
HCC Liver cancer was added to the CE Mark filing after regulatory advice as it serves to considerably strengthen the filing position and carries no additional regulatory risk.
It comes after clinical studies conducted confirmed OncoSil™’s ability to demonstrate tumour shrinkage in both solid tumour indications of pancreatic and liver cancer.
How OncoSil™ works
The OncoSil™ device is inserted directly into the centre of the tumour using well established technology.
Radiation therapy such as that supplied by OncoSil™ is known to kill tumour cells.
OncoSil™ is classed by regulators as a class III medical device not a drug.
In drug development human studies are typically undertaken as phase I phase II and phase III studies. In medical device development studies are undertaken as pilot and pivotal/registration studies.
Therefore medical devices typically require less clinical trial work for approval less funding and have a faster time to approval when compared to drug development.
ISO certification
recently announced it had been granted ISO 13485:2012 and ISO 13485:2003 certification for OncoSil™ for the design development and control of manufacture of the device in the area of oncology.
This is a pivotal and key requirement for CE Marking of medical devices in the European Union.
Analysis
is on-track to commercialise OncoSil™ in the European Union with filing on schedule for the Conformité Européenne (CE) Mark approval in Q3 2015.
Commercialisation in the European Union would be a milestone for the company and would also facilitate sales in other major markets.
The global market for Pancreatic Cancer is US$1 billion and for HCC Liver Cancer an additional US$1.4 billion.
The company has total cash and credits of over $9 million.
Proactive Investors Australia is the market leader in producing news articles and research reports on ASX emerging companies with distribution in Australia UK North America and Hong Kong / China.
Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.