Doctors at the Prostate Centre at the BC Cancer Agency and at Vancouver General Hospital have signed up the first patients for a Phase I Clinical Trial of OGX-011. OGX-011 is an inhibitor of clusterin, a key protein that makes tumours resistant to conventional treatment. In laboratory studies, blocking the production of clusterin with OGX-011 significantly enhances the efficacy of current cancer treatments, resulting in delayed progression of the disease. This new antisense drug promises to sensitize tumors resistant to existing treatments such as chemotherapy, hormone ablation therapy and radiation therapy.

Laboratory studies at the Prostate Centre at VGH demonstrated that OGX-011 dramatically improved the potency of traditional chemotherapies in prostate cancer without compromising safety. When combined with other cancer treatments in pre-clinical model systems, OGX-011 significantly improved tumor reduction and delayed disease progression in prostate, lung, bladder and renal cancer. In these studies, tumors that were resistant to traditional treatments were rendered sensitive to those therapies by administration of OGX-011.

"We are tremendously excited by OGX-011 and its potential impact on cancer treatment," said Dr. Kim Chi, Medical Oncologist at the BC Cancer Agency.

Isis Pharmaceuticals Inc. and OncoGenex Technologies Inc. established a co-development and commercialization collaboration for OGX-011 in November 2001, in order to advance the drug into clinical development. "We plan to develop OGX-011 for a number of major cancers including prostate, lung, bladder and other tumor types which produce high levels of clusterin," said Scott Cormack, President and CEO of OncoGenex.

The first Phase I trial will evaluate OGX-011 in combination with hormone therapy prior to surgical removal of the prostate. In addition to measuring the reduction of clusterin levels in tumor tissue and blood cells, safety and tolerability will be assessed. This study is being funded in part by the United States Department of Defense, and is coordinated by the National Cancer Institute of Canada Clinical Trials Group.

A second Phase I trial, scheduled to begin early next year, will evaluate OGX-011 in combination with TAXOTERE(R) in various solid tumors. The Canadian Cancer Society has provided more than $690,000 in funding for this trial. Aventis Pharmaceuticals is providing the hormone ablation and chemotherapy drug supply for the two Phase I trials, as well as partial funding for the studies.

Approximately 60 patients will be enrolled in the two OGX-011 Phase I trials. Both studies will be conducted at the BC Cancer Agency and the Vancouver General Hospital with Dr. Kim Chi as the principal investigator.

"This is OncoGenex's first drug candidate to enter clinical trials, and we are optimistic about its potential as a treatment for prostate cancer and other tumor types," said Dr. Martin Gleave, Professor of Surgery at UBC, OncoGenex's Chief Scientific Officer, and inventor of OGX-011.

"It's particularly exciting to see novel targeted therapeutics discovered and developed at The Prostate Centre move from the bench into clinical trials," said Dr. Larry Goldenberg, Director of the Prostate Centre.

The Canadian Cancer Society and National Cancer Institute of Canada estimate that 18,200 new cases of prostate cancer, 20,500 of breast cancer and 20,800 of lung cancer will be diagnosed this year. Lung cancer is the leading cause of cancer-related death in Canada.

For more information, please contact:
Nicole Adams
Public Relations Officer
BC Cancer Agency
(604) 877-6272
nadams@bccancer.bc.ca