"Bladder cancer is often sensitive to chemotherapy in the first-line setting, but, when patients relapse, resistance to chemotherapy is frequent," stated
Limited options exist for both the first- and second-line treatment of advanced bladder cancer. Currently, first-line platinum-based chemotherapy regimens result in a median overall survival of approximately 12-15 months. Docetaxel is commonly used in second-line treatment, with a reported median overall survival of approximately six months. Given acquired treatment resistance and these short survival times, there continues to be a high unmet need for additional therapeutic options for this patient population.
OGX-427 is designed to inhibit Heat Shock Protein 27 (HSP27), a cell-survival protein found at elevated levels in many human cancers including prostate, bladder, breast and non-small cell lung cancer. Overexpression of Hsp27 is thought to be an important factor leading to the development of treatment resistance and is associated with negative clinical outcomes in patients with various tumor types.
"The launch of Borealis-2 marks OncoGenex' continued commitment to expanding the OGX-427 clinical development program to better understand treatment resistance in GU cancers," said
Borealis-2 will be the second randomized, controlled clinical trial of OGX-427 in advanced bladder cancer. The Borealis-1 clinical trial is the OncoGenex-sponsored, randomized, placebo-controlled Phase 2 study designed to evaluate a potential survival benefit, safety and tolerability of combining OGX-427 with gemcitabine and cisplatin in the first-line treatment of patients with advanced bladder cancer. If either Borealis trial shows a survival advantage, OncoGenex plans to initiate conversations with the
The Borealis-2 clinical trial will randomize approximately 200 patients to receive either OGX-427 plus docetaxel treatment or docetaxel treatment alone. Patients may also continue weekly OGX-427 infusions as maintenance treatment until disease progression or unacceptable toxicity if they complete all 10 planned cycles of docetaxel or are discontinued from docetaxel due to docetaxel toxicity. The primary objective will be overall survival, with secondary objectives evaluating safety, tolerability, tumor response rates and the effect of therapy on Hsp27 levels and circulating tumor cells.
Borealis-2 will be conducted at approximately 30 sites in the U.S. and is being sponsored by the
The "ORCA" (Overcoming Resistance in CAncer) program encompasses the on-going studies of OGX-427 aiming to demonstrate that inhibition of Hsp27 can lead to improved prognosis and treatment outcomes for cancer patients. Phase 2 clinical trials are underway in prostate and bladder cancers, with additional studies expected to initiate this year. For more information on OGX-427 and ORCA, please visit www.oncogenex.com.
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OncoGenex and
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 our anticipated product development activities, such as expected clinical trial completion and design and statements regarding the potential benefits and potential development of our product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. 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. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that our product candidates will not demonstrate the hypothesized or expected benefits, the risk of delays in our expected clinical trials, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our clinical trial plans or limit the potential benefits of our product, the risk that our cash resources are insufficient to fund our planned activities for the time period expected and the other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. 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.
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