OncoGenex Announces that a Randomized, Investigator-Sponsored Phase 2 Study
Evaluating OGX-427 has Received Grant Funding
BOTHELL, WA and
The randomized, controlled Phase 2 study will enroll up to 72 patients and is designed to determine the potential benefit of OGX-427 by evaluating the number of patients who are without disease progression at 12 weeks post study treatment with or without OGX-427. This Phase 2 trial will also measure the direct effect of OGX-427 on PSA levels, time to progression by PSA or measurable disease, numbers of circulating tumor cells (CTCs) and other relevant secondary endpoints. The trial is expected to start by mid 2010 following final analysis of Phase 1 data and approval by Health
OGX-427 is a second-generation antisense drug that is designed to reduce production of Heat Shock Protein 27 (Hsp27), a cell-survival protein that inhibits treatment-induced cell death through multiple pathways, including the androgen receptor (AR). Preclinical studies have shown that androgen bound to the AR on prostate tumor cells induces rapid Hsp27 phosphorylation that in turn enhances AR activity and prostate cancer cell survival. OGX-427-induced knockdown of Hsp27 led to AR degradation, decreased PSA levels, and delayed progression of castration resistant prostate tumors.
"The results from our Phase 1 program supports the development of OGX-427 in a number of solid tumors. This grant-funded Phase 2 trial in prostate cancer complements a separate ongoing clinical investigation of OGX-427 in bladder cancer funded by the National Cancer Institute of
"The reduction in circulating tumor cells and tumor markers seen during a previously reported Phase 1 study of OGX-427 administered as a single agent has been very encouraging," said
"This Phase 2 trial of OGX-427 is designed to confirm the pre-clinical observations that OGX-427 inhibits multiple Hsp27-regulated pathways that enhance prostate tumor cell survival," said
About OGX-427
OGX-427 is designed to reduce levels of Hsp27, a protein that is over-produced in response to many cancer treatments including hormone ablation therapy, chemotherapy and radiation therapy. Hsp27 production has been shown to inhibit cell death in tumor cells through a variety of mechanisms.
In
OGX-427 is also being evaluated in a separate Phase 1 clinical trial for the systemic (intravenous) treatment of solid tumors including prostate, non-small cell lung, breast, ovarian, and bladder cancers. OncoGenex announced preliminary results of this Phase 1 trial presented during an oral presentation at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting. Results as of
About OncoGenex Pharmaceuticals
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new cancer therapies that address treatment resistance in cancer patients. OncoGenex has a deep oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OncoGenex and Teva Pharmaceutical have entered a global collaboration and license agreement to develop and commercialize OncoGenex's lead drug candidate, OGX-011. The companies expect to initiate two Phase 3 trials in castrate resistant prostate cancer in 2010, and a third Phase 3 trial in non-small cell lung cancer in early 2011; OGX-427 is in Phase 1 clinical development; SN2310 has completed a Phase 1 clinical trial; and CSP-9222 and OGX-225 are currently in pre-clinical development.
OGX-011, OGX-427 and OGX-225 utilize second-generation antisense technology, licensed from Isis Pharmaceuticals (NASDAQ: ISIS), to target and inhibit production of specific proteins which OncoGenex believes are important in tumor progression and treatment resistance. Key intellectual property related to OGX-011, OGX-427 and OGX-225 were discovered by the University of British Columbia and the
OncoGenex' Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning anticipated clinical and other product development activities and timing and costs of these activities. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk factors set forth in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for fiscal year 2008. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
More information about OncoGenex is available at www.oncogenex.com.
For further information: OncoGenex Contact: Scott Cormack, President & CEO, (604) 630-5400, [email protected]; Media and Investor Contact: Jason Spark, Porter Novelli Life Sciences, (619) 849-6005, [email protected]
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