This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

OncoGenex Announces Plans For The Initiation Of The Rainier™ Clinical Trial Evaluating OGX-427 In Combination With ABRAXANE® Plus Gemcitabine In Patients With Metastatic Pancreatic Cancer

Stocks in this article: OGXITEVA

BOTHELL, Wash. and VANCOUVER, British Columbia, May 1, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the initiation of the Rainier™ trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating OGX-427 in combination with ABRAXANE ® (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine in patients with previously untreated metastatic pancreatic cancer.

Rainier will randomize approximately 130 patients to receive either OGX-427 or placebo in combination with ABRAXANE and gemcitabine therapy. The primary endpoint of the trial will be overall survival, with additional analyses to evaluate progression-free survival (PFS), tumor response rates, safety, tolerability, and the effect of therapy on heat shock protein (Hsp27) levels.

"Based on the positive survival results demonstrated by the Phase 3 MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) trial, many patients with advanced pancreatic cancer will undoubtedly receive treatment with gemcitabine plus ABRAXANE in the future. However, survival times remain short for these patients, and we need to continue to explore new strategies to address treatment resistance," stated Andrew H. Ko MD, Associate Professor of Medicine, Division of Hematology/Oncology at the University of California, San Francisco, and a primary investigator on the trial. "The Rainier trial provides us the opportunity to explore the role of Hsp27 in pancreatic cancer, and the potential ability of OGX-427 to improve on clinical outcomes when added to combination chemotherapy."

The trial is being sponsored by the Sarah Cannon Research Institute (SCRI) and will be conducted at approximately 12 sites in the United States. Dr. Andrew H. Ko from the University of California, San Francisco, and Dr. Johanna Bendell, Director, GI Cancer Research Program at SCRI, will serve as the primary investigators on the trial. "We are very excited to bring this trial of an exciting novel agent to patients with metastatic pancreatic cancer, who desperately need more treatment options," said Dr. Bendell.  

ABOUT PANCREATIC CANCERPancreatic cancer accounts for approximately 279,000 new cases each year worldwide. In the United States, an estimated 45,000 people will be diagnosed with pancreatic cancer and approximately 38,500 will die from the disease in 2013. Most pancreatic cancer patients will die within the first year of diagnosis, and five-year survival rates are only about 6 percent. An estimated 85 to 90 percent of patients present with locally advanced or metastatic disease. Median five-year survival for patients diagnosed with stage IV disease is just 4.5 months, demonstrating the need for new therapies with improved efficacy.

ABOUT OGX-427 and ORCA™OGX-427 is a once-weekly intravenous (IV) drug that is designed to inhibit production of heat shock protein (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.

The ORCA ( Ongoing Studies Evaluating Treatment Resistance in CAncer) program encompasses clinical trials of OGX-427. Phase 2 clinical trials are underway in bladder, lung, pancreatic and prostate cancers, with additional updates to the ORCA program expected to be provided later this year. For more information on OGX-427 and ORCA, please visit www.OncoGenex.com.

ABOUT ONCOGENEXOncoGenex 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 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global collaboration and license agreement to develop and commercialize OncoGenex' lead drug candidate, custirsen. 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. OGX-427 is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com.

ABOUT SCRISarah Cannon Research Institute (SCRI) is a global strategic research organization focusing on advancing therapies for patients. It is one of the largest clinical research programs, conducting community-based clinical trials in oncology and cardiology through affiliations with a network of more than 700 physicians in the United States and United Kingdom. Additionally, SCRI offers management, regulatory and other research support services to drug development sponsors and strategic investigator sites. For more information, please visit sarahcannonresearch.com.

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, 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 candidates 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.

ABRAXANE ® is a registered trademark of Celgene Corporation. ORCA™ and Rainier™ are registered trademarks of OncoGenex Pharmaceuticals, Inc.

SOURCE OncoGenex Pharmaceuticals, Inc.

Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,598.56 +198.89 1.21%
S&P 500 1,937.41 +33.40 1.75%
NASDAQ 4,411.3850 +95.3110 2.21%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs