Survival Benefit Seen with Custirsen and Apatorsen in Patients with Greatest Therapeutic Need
BOTHELL, Wash. and VANCOUVER, May 20, 2015 /CNW/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that clinical data on its lead product candidates, custirsen and apatorsen, will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 29-June 2. Custirsen and apatorsen are currently being evaluated in two Phase 3 trials and five Phase 2 trials, respectively, across a variety of cancer indications, including prostate, non-small cell lung, pancreatic and bladder cancers.
"The SYNERGY and Borealis-1™ data to be presented at ASCO provide substantial clinical evidence that our products have the potential to improve survival in the most vulnerable patients – those at risk for poor outcomes," said Scott Cormack, president and CEO of OncoGenex. "These data underscore the importance of understanding the factors that drive poor outcomes across tumor types and evaluating these compounds in the specific patient sub-populations that are most likely to benefit, as well as in the most aggressive cancers where survival rates are persistently low."
The ASCO schedule, abstract information and meeting locations for the sessions include:
- Phase III SYNERGY trial: Docetaxel +/- custirsen and overall survival in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and poor prognosis (Poster, Abstract #5009)
- Poster: Saturday, May 30, 1:15 PM CDT – S Hall A
- Poster Discussion: Saturday, May 30, 4:45 PM CDT - E Arie Crown Theater
- First-line randomized phase II study of gemcitabine/cisplatin plus apatorsen or placebo in patients with advanced bladder cancer: The International Borealis-1 trial (Oral Session, Abstract #4503)
- Monday, June 1, 9:45 AM CDT - E Arie Crown Theater
- The Borealis-2™ clinical trial: A randomized phase 2 study of OGX-427 (Apatorsen) plus docetaxel versus docetaxel alone in relapsed/refractory metastatic urothelial cancer (Poster, Abstract #TPS4577)
- Monday June 1, 1:15 PM CDT – S Hall A, Board #247b
- Addition of apatorsen, an inhibitor of Hsp27, to first-line gemcitabine/carboplatin in advanced squamous cell lung cancer: Design of the Cedar™ study (Poster, Abstract #TPS8111)
- Monday June 1, 8:00 AM CDT – S Hall A, Board #431b
Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation and radiation therapy and has been found to be overexpressed in a number of cancers, including prostate, lung, breast and bladder. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration in patients. By inhibiting clusterin, custirsen is designed to alter tumor dynamics, slowing tumor growth and resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.
Custirsen has Fast Track designation by the U.S. Food and Drug Administration for NSCLC and metastatic castrate-resistant prostate cancer.
About Apatorsen and ORCA™
Apatorsen (OGX-427) is a once-weekly intravenous (IV) experimental drug that is designed to inhibit production of heat shock protein 27 (Hsp27) to disable cancer cells' defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes. Both the potential single-agent activity and synergistic activity of apatorsen with cancer treatments may increase the overall benefit of existing therapies and augment the durability of treatment outcomes, which could lead to increased patient survival.
The ORCA (Ongoing Studies Evaluating Treatment Resistance in CAncer) program encompasses clinical trials of apatorsen. Phase 2 clinical trials are underway in bladder, lung, pancreatic and prostate cancers. For more information on apatorsen and ORCA, please visit www.OncoGenex.com or www.orcatrials.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. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. Apatorsen is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com and at the company's Twitter account: https://twitter.com/OncoGenex_IR.
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 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 do 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.
Borealis-1™, Borealis-2™, Cedar™ and ORCA ™are registered trademarks of OncoGenex Pharmaceuticals, Inc.
SOURCE OncoGenex Pharmaceuticals, Inc.
For further information: Jaime Welch, 604-736-3678, [email protected], http://oncogenex.com/