Oncolytics Biotech Inc. (ONCY)

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Calgary Herald - Oncolytics soars on nod for trial

http://www.calgaryherald.com/health/Oncolytics+soars+trial/2061344/story.html

Oncolytics soars on nod for trial

Cancer treatment advances at U. S. drug regulator

BY LISA SCHMIDT, CALGARY HERALDOCTOBER 3, 2009COMMENTS (1)


Oncolytics Biotech Inc. marked a milestone Friday after getting the go-ahead from the U. S. Food and Drug Administration on its plan on late-stage trials for its cancer treatment.

The company said the research could eventually support a licence application submission for Reolysin, which uses a naturally occurring reovirus to target mostly solid-tumour cancers that have a tendency to spread, or metastasize, such as in head and neck tumours.

"It's a little bit daunting, and a little bit exciting to be the first," Brad Thompson, chief executive for Oncolytics, said in a conference call with analysts Friday.

The announcement sent shares of the Calgary-based biotechnology company soaring to their highest levels in three years. Oncolytics shares closed up 53 cents to $3.71 on the Toronto Stock Exchange on Friday. The stock rose as high as $4.10 a share in earlier trading.

The testing will look at the effectiveness of using the treatment in combination with regular chemotherapy.

"This (trial) provides an agreed upon path for product development from now until submission for product approval," Thompson said.

"It allows us to proceed into this Phase 3 trial with the confidence that if the trial is successful, we should be able to move forward toward product approval in the United States and also provide guidance toward the use of Reolysin in other cancer applications."

Oncolytics "is in active discussions" for a partner to help fund the next phase of research--which will cost about $15 million, or about $60,000 a patient. But Thompson said the company will likely proceed with the first stage of the trials, which will involve about 80 patients throughout the U. S., the U. K. and Europe. The second phase is expected to include between 100 and 400 patients.

For a drug to reach the market, it generally has to go through extensive research and testing on animals, then four phases of controlled clinical trials on humans. The third phase is considered the most important stage in any new drug's development.

Many trials stall before hitting this crucial stage, as results show treatments are ineffective or have adverse reactions, said one researcher.

"To get to this stage is actually already a big achievement," said Dr. Randy Johnston, a professor in cancer research at the University of Calgary's Faculty of Medicine.

"As far as I'm aware, it's the first new generation cancer therapy that uses this kind of virus . . . to get through to a Phase 3 trial."

Oncolytics started develop Reolysin a decade ago with research started at the University of Calgary.

Since then, Oncolytics has enrolled approximately 330 patients in clinical studies, gone public and recently partnered with the Cancer Therapy and Research Center at the University of Texas Health Sciences Center in San Antonio.

"We're very proud that a discovery that began here in Calgary is getting to this level," added Johnston.

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