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VANCOUVER, British Columbia, and CARLSBAD, Calif., Dec. 16 /PRNewswire-FirstCall/ -- OncoGenex Technologies Inc. and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today the initiation of a Phase I clinical trial of OGX-011 in patients with prostate cancer. OGX-011 is an antisense drug being developed to sensitize tumors resistant to existing treatments such as chemotherapy, hormone ablation therapy and radiation therapy, and is the first anticancer antisense drug with Isis' second generation chemistry to enter clinical development. Isis and OncoGenex established a co-development and commercialization collaboration for OGX-011 in November 2001.

"We are very pleased that the co-development partnership between OncoGenex and Isis has successfully delivered on its intent to advance OGX-011 into clinical development in 2002," said Scott Cormack, President and CEO of OncoGenex.

OGX-011 is an inhibitor of clusterin, a key protein that makes tumors resistant to conventional treatment. In pre-clinical studies, blocking the production of clusterin with OGX-011 significantly enhances the efficacy of current cancer treatments, resulting in delayed progression of the disease. OncoGenex and Isis plan to develop OGX-011 for a number of major cancers including prostate, lung, bladder and others; tumor types in which clusterin is well known to be over-expressed. In addition to this study, a second Phase I trial of OGX-011 is scheduled to begin early next year.

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 being sponsored by the National Cancer Institute of Canada Clinical Trials Group. The second Phase I study will evaluate OGX-011 in combination with TAXOTERE® in various solid tumors. Aventis Pharmaceuticals is providing hormone ablation and chemotherapy drug supply for the first and second Phase I studies respectively, as well as grant-in-aid for both studies. Approximately 60 patients in total are planned to be enrolled in the two OGX-011 Phase I trials. Both Phase I studies will be conducted in Vancouver, Canada at the British Columbia Cancer Agency and the Vancouver General Hospital with Dr. K. N. Chi, Medical Oncologist 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 Martin E. Gleave, M.D., OncoGenex's Chief Scientific Officer.

"OGX-011 is Isis' third anti-cancer drug in human clinical trials. Clusterin is an exciting cancer target, and coupled with our second generation chemistry, significantly broadens the scope of the types of cancer we can potentially treat," said F. Andrew Dorr, M.D., Isis Vice President and Chief Medical Officer. "We are hopeful that OGX-011 may provide cancer patients with an additional treatment option."

In pre-clinical studies, scientists at the Prostate Centre at Vancouver General Hospital, OncoGenex and Isis demonstrated that OGX-011 improved the potency of traditional chemotherapies more than 10-fold in prostate cancer without compromising safety. When combined with other cancer treatments in pre-clinical model systems, OGX-011 has been shown to significantly improve tumor reduction and delay disease progression in prostate, lung, bladder and renal cancer. In these studies, tumors that are inherently resistant or that develop resistance to other therapeutic strategies are rendered sensitive to these other therapies by administration of OGX-011. As part of the co-development partnership, OncoGenex was responsible for conducting the pre-clinical pharmacology studies of OGX-011 and filing the Clinical Trials Application (CTA) in Canada and Investigational New Drug (IND) application in the United States. Isis conducted pre-clinical toxicology and pharmacokinetic studies of the drug candidate in support of the Phase I studies and has manufactured OGX-011 for the first two Phase I trials.

The OncoGenex and Isis partnership combines OncoGenex's proprietary antisense position in inhibitors to the target, clusterin, with Isis' proprietary second-generation antisense chemistry called 2'-O-methoxyethyl. Second-generation antisense drugs offer greater potency, enhanced tolerability, and improved dosing convenience compared to first-generation antisense drugs.

The American Cancer Society estimates that 189,000 new cases of prostate cancer, 203,500 of breast cancer and 169,400 of lung cancer will be diagnosed in 2002, making prostate cancer the leading cancer diagnosed in men and breast cancer the leading cancer diagnosed in women. The leading cause of cancer- related death for men and women remains lung cancer, which the American Cancer Society estimates will claim 154,900 lives in 2002. The Canadian Cancer Society and National Cancer Institute of Canada estimate similar outcomes in Canada in 2002: 18,200 new cases of prostate cancer, 20,500 of breast cancer and 20,800 of lung cancer will be diagnosed, and lung cancer will be the leading cause of cancer-related death in Canada.

OncoGenex Technologies Inc. is a Vancouver-based biotechnology company developing targeted cancer therapeutics designed to inhibit the tumor cells' ability to adapt when treated with conventional therapies. OncoGenex has five products in development and is the exclusive licensee of technologies from the University of British Columbia and the Vancouver Hospital & Health Sciences Centre. The company has working relationships with many institutions worldwide, including the Division of Urology and the Prostate Centre at Vancouver Hospital & Health Sciences Centre. Additional information about OncoGenex is available at www.oncogenex.ca .

Isis Pharmaceuticals, Inc. is exploiting its expertise in RNA to discover and develop novel human therapeutic drugs. The company has commercialized its first product, Vitravene® (fomivirsen), to treat CMV-induced retinitis in AIDS patients. In addition, Isis has 13 antisense products in its development pipeline with two in late-stage development and six in Phase II human clinical trials. Affinitak™, an inhibitor of PKC-alpha, is in Phase III trials for non-small cell lung cancer, and alicaforsen (ISIS 2302), an ICAM-1 inhibitor, is in Phase III trials for Crohn's disease. Isis has a broad patent estate as the owner or exclusive licensee of more than 1,000 issued patents worldwide. Isis' GeneTrove™ division uses antisense to assist pharmaceutical industry partners in validating and prioritizing potential gene targets through customized services. Ibis Therapeutics™ is a division focused on the discovery of small molecule drugs that bind to RNA. Additional information about Isis is available at www.isispharm.com .

This press release contains forward-looking statements about the potential of the investigational compound OGX-011 in the treatment of prostate, breast, lung, bladder, ovarian and renal cancers, Isis Pharmaceuticals' collaboration with OncoGenex and the potential of Isis' drug development programs. Any statement describing a goal, expectation, intention or belief of the company is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and financing such activities. Actual results could differ materially from those projected in this release. As a result, you are cautioned not to rely on these forward- looking statements. These and other risks concerning Isis' research and development programs are described in additional detail in the company's Annual Report on Form 10-K and quarterly report on Form 10-Q for the periods ended December 31, 2001 and September 30, 2002, respectively, which are on file with the U.S. Securities and Exchange Commission, copies of which are available from the company.

Affinitak™, a trademark of Eli Lilly and Company, is an investigational cancer compound being developed through an alliance between Lilly and Isis Pharmaceuticals, Inc. and marketed globally by Lilly.

GeneTrove™ and Ibis Therapeutics™ are trademarks of Isis Pharmaceuticals, Inc.

    Vitravene® is a registered trademark of Novartis AG.
    TAXOTERE® is a registered trademark of Aventis.



                     

SOURCE OncoGenex Technologies Inc.; Isis Pharmaceuticals, Inc.