Oncolytics: Cancer Virotherapy - Risky but Astronomical Upside

and another one, price now up 11% at $2.32-$2.36....time to wake up?

1/3/2007 10:34:40 AM ET News Release Index

Oncolytics Biotech Inc. Announces Approval for U.K. Clinical Trial Investigating REOLYSIN® in Combination with Gemcitabine

CALGARY, AB, --- January 3, 2007 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its Clinical Trial Application (CTA) to begin a clinical trial using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar®) in patients with advanced cancers including pancreatic, lung and ovarian. The principal investigators are Dr. Johann de Bono of The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London and Professor Jeff Evans of the University of Glasgow and the Beatson Oncology Centre in Glasgow, Scotland. Gemcitabine is used in patients with lung, pancreatic and ovarian cancers and is also used widely in the treatment of many other types of cancers.

“The combination of REOLYSIN® and gemcitabine was synergistic in preclinical studies,” said Dr. Brad Thompson, President and CEO of Oncolytics. “The data gathered in this study is expected to assist the company in further defining the optimal path to product registration. Drug combination studies allow us to investigate REOLYSIN® with drugs that are part of the current standard of care.”

Preclinical studies conducted at Cornell University demonstrated that the combination of gemcitabine and REOLYSIN® was synergistic against selected cancer cell lines. This work was verified by additional studies conducted by the U.S. National Cancer Institute (NCI).

This trial (REO 009) has two components. The first is an open-label, dose-escalating, non-randomized study of REOLYSIN® given intravenously with gemcitabine every three weeks. A standard dosage of gemcitabine will be delivered with escalating dosages of REOLYSIN® intravenously. A maximum of three cohorts will be enrolled in the REOLYSIN® dose escalation portion. The second component of the trial will immediately follow and will include the enrolment of a further 12 patients at the maximum dosage of REOLYSIN® in combination with a standard dosage of gemcitabine.