OncoGenex Technologies Inc announced the initiation of a second, planned Phase I clinical trial of OGX-011 in combination with Taxotere to treat patients with a variety of solid tumors. OGX-011 is currently in an additional Phase I trial in patients with prostate cancer. OGX-011 is an antisense drug being developed to sensitize tumors resistant to existing treatments such as chemotherapy. OncoGenex is co-developing OGX-011 with Isis Pharmaceuticals.
"This trial is intended to demonstrate the safety of OGX-011 in combination with chemotherapy in patients with prostate, lung, renal, ovarian and bladder cancer. We see this trial as serving as the basis to subsequently evaluate OGX-011 in parallel Phase II studies directed to specific tumor types," said Martin E. Gleave, OncoGenex's Chief Scientific Officer.
Approximately 30 patients across Canada are planned to be enrolled in the Phase I trial. Dr. K. N. Chi, a Medical Oncologist at the BC Cancer Agency is the Principal Investigator on the study.
OGX-011 is the first anticancer antisense drug based on Isis' second- generation chemistry to enter clinical development. The drug is an inhibitor of clusterin, a key protein that makes tumors resistant to conventional treatment.
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, renal and several other cancers. 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.
In addition to the support provided for the Phase I trial of OGX-011 in prostate cancer, initiated in December 2002, Aventis Pharma Inc. is providing a grant-in-aid and the chemotherapy agent Taxotere for this second study.
Isis and OncoGenex established a co-development and commercialization collaboration for OGX-011 in November 2001. The 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 Canadian Cancer Society is also providing funding for the clinical trial. The trial is being coordinated by the National Cancer Institute of Canada Clinical Trials Group.
In total, the American Cancer Society estimated that prostate, lung, renal, ovarian and bladder cancers would account for 470,000 new diagnoses and 223,200 deaths in the United States in 2002. Lung cancer remains the leading cause of cancer-related death for both men and women, claiming nearly 155,000 lives in the United States alone every year, according to the American Cancer Society.