Oncolytics Biotech® (
TSX: ONC,
Stock Forum) pushed the commercialization process forward for its lead product candidate when the company announced today that the European Medicines Agency (“EMA”) had granted Orphan Drug Designation for RESOLYSIN™ for the treatment of pancreatic cancer.
According to the
news release, this designation is given out to drugs intended to treat, prevent, or diagnose life-threatening and debilitating disease with a prevalence of no greater than five in 10,000 in the EU and where there isn’t any satisfactory method of treatment, prevention or diagnosis, unless the proposed medicine significantly advances the aforementioned efforts.
As a result of this classification, the company can access a variety of incentives including protocol assistance, market exclusivity for a ten-year term after approval and potential fee reductions. This designation does not however, modify regulatory requirements or the process for gaining marketing approval.
Company President and CEO, Dr. Brad Thompson, commented, “Our submission to the EMA included survival data from our single arm gemcitabine/REOLYSIN® (REO 017) clinical study in pancreatic cancer patients, which factored into their decision to grant us the designation,”
RESOLYSIN™ is the company’s proprietary isolate of the reovirus and is intended to infect and selectively target tumors with activating Ras pathway mutations and/or over-expressions of Ras pathway elements.
Oncolytics Biotech® was in the news recently when
the Calgary-based firm announced yesterday that it would regain compliance with NASDAQ’s minimum bid price rule.
Shares gained 3.53% on the news to $0.88 per share.
Currently there are 109.7m outstanding shares with a market cap of $96.5 million.