Vancouver developed targeted drug-therapy for prostate cancer shows promise: Results from Phase I Clinical Trial released in prestigious Journal of the National Cancer Institute.

Results of a Phase I prostate cancer clinical trial show that a new targeted drug significantly reduces the expression of a protein which causes tumours to become resistant to treatment. The prestigious Journal of the National Cancer Institute published the results this week.

The drug, OGX-011 – a new class of smart drugs – targets cancer cells at the molecular level. OGX-011 works by sensitizing tumours that have become resistant to conventional treatment such as chemotherapy, hormone therapy and radiation therapy. Specifically, OGX-011 targets the protein clusterin, which is expressed in many cancers. Clusterin prevents cancer cell death thereby undermining the effectiveness of standard therapies.

For the study, researchers from the BC Cancer Agency, an agency of the Provincial Health Services Authority, and the Prostate Centre at Vancouver General Hospital recruited 25 patients with localized prostate cancer (cancer contained to one site) and candidates for a prostatectomy, but who were at higher risk of their cancer relapsing. Patients received escalating doses of OGX-011 over a one-month period along with hormone therapy prior to their radical prostatectomy. At the highest dose, researchers found that clusterin expression was reduced by more than 90 per cent. Even at the highest dose the drug was well-tolerated with no severe side-effects.

"With this study, we were able to determine that OGX-011 is biologically doing what it's supposed to and at a dose that is well-tolerated by patients," says Dr. Kim N. Chi, principal investigator and medical oncologist with the BC Cancer Agency and the Prostate Centre at VGH.

Based on the strength of the Phase I clinical data, researchers at the BC Cancer Agency and the Prostate Centre at VGH are now leading Phase II clinical trials for prostate, breast and lung cancers. "We were able to identify the optimum dose of the drug in Phase I trials, and that the drug causes more cancer cells to die during treatment than would have otherwise," says Dr. Martin Gleave, Director of Clinical Research at the Prostate Centre at VGH. "What we want to find out in Phase II trials is does this translate into a benefit for patients?" Phase II trials will be conducted in centres across Canada and the USA.

The pre-surgery study was supported through a grant from the US Department of Defense Army Medical Research and Materials Command. The study was coordinated by the Clinical Trials Group (based at Queens University) of the National Cancer Institute of Canada, which is funded by the Canadian Cancer Society. An unrestricted grant-in-aid was provided by sanofi-aventis Canada.

OGX-011 was discovered and patented by a team of researchers led by Dr. Martin Gleave at the Prostate Centre at VGH. OncoGenex Technologies, a Vancouver-based biotechnology company spun-out from the Prostate Centre and the University of British Columbia, has since licensed OGX-011 and is currently developing and commercializing OGX-011 with corporate partner Isis Pharmaceuticals. "The Vancouver drug development network, including leading research centres, emerging biotechnology companies, and entrepreneurs, is a model for how new knowledge and discoveries can quickly be translated from the laboratory bench to the patients' bedside," says Scott Cormack, President and CEO of OncoGenex.

In addition to Drs. Chi and Gleave, the paper's authors include Drs. Larry Goldenberg, Elizabeth Eisenhauer, Ladan Fazli, Edward Jones, Jean Powers and Dongsheng Tu.

The BC Cancer Agency, a part of the Provincial Health Services Authority, is committed to reducing the incidence of cancer, reducing the mortality from cancer, and improving the quality of life of those living with cancer. It provides a comprehensive cancer control program for the people of British Columbia by working with community partners to deliver a range of oncology services, including prevention, early detection, diagnosis and treatment, research, education, supportive care, rehabilitation and palliative care. The BC Cancer Research Centre conducts research into the causes and cures for cancer.

The Prostate Centre at Vancouver General Hospital (established in 1993) is a national Centre of Excellence, Canada's most comprehensive, and one of the world's leading facilities for research and treatment of prostate cancer. The Prostate Centre is part of the Vancouver Coastal Health Authority and comes under its research umbrella, the Vancouver Coastal Health Research Institute. The Centre's focus is not just prostate cancer, but other benign diseases of the prostate.

The Vancouver Coastal Health Research Institute is the research body of Vancouver Coastal Health Authority. In academic partnership with the University of British Columbia and philanthropic partnership with VGH & UBC Hospital Foundation, we bring innovation and discovery to patient care, advancing healthier lives in healthy communities across British Columbia, Canada, and beyond.

For more information, please contact:

Papinder Rehncy Public Relations BC Cancer Agency an agency of the Provincial Health Services Authority prehncy@bccancer.bc.ca

Lisa Carver    Communications Specialist    Vancouver Coastal Health/    Vancouver Coastal Health Research Institute    Tel: 604.875.4111 x 61777    Cell:604.319.7533