SOUTH SAN FRANCISCO, Calif., Dec. 9 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. , a biopharmaceutical company, today announced results of a Phase III study with PTI-901, an investigational drug candidate for the treatment of irritable bowel syndrome (IBS).
This randomized, double-blinded, multi-center U.S. study compared a daily dose of PTI-901 against placebo in 600 women with documented IBS over a three-month treatment period. PTI-901 showed a favorable safety profile and patients reported statistically meaningful relief of IBS symptoms in the second month of treatment (p<0.02), but the drug did not demonstrate a meaningful benefit in the third month of treatment, which was defined as the primary endpoint. According to current regulatory standards, an experimental drug for chronic IBS needs to show efficacy at the end of a three-month treatment period.
The Company believes this study was well designed to detect any durable benefits of PTI-901 versus placebo in a large patient population with IBS. Based on the adequacy of the study itself, coupled with today’s clinical results, the Company is discontinuing all further clinical development activities with PTI-901.
“This is an opportunity to sharpen our focus on our late-stage pipeline,” said Remi Barbier, president and chief executive officer of Pain Therapeutics. “We’re ready to start 2006 with a strong balance sheet, a modest cash burn rate and two lead drug candidates in Phase III clinical development. In addition, in 2006 we plan to add depth to the pipeline by announcing, with our commercial partner, Investigational New Drug applications for one or more new abuse-resistant opioid painkillers.”
Pain Therapeutics expects to have over $200 million of cash at the end of 2005. The Company expects a net cash burn rate of under $15 million in 2006.
About Pain Therapeutics, Inc.
We are a biopharmaceutical company that develops novel drugs. We have two lead drug candidates in late-stage clinical trials, Remoxy(TM) and Oxytrex(TM). Both drugs are in Phase III programs and are aimed at different segments of the multi-billion dollar market to treat severe chronic pain, such as low-back pain or pain due to osteoarthritis.
Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). PTI disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company’s clinical development of its drug candidates (including the filing of additional IND applications in 2006), the potential benefits of the Company’s drug candidates, the Company’s cash position at the end of 2005 and the Company’s expected cash burn in 2006, and the size of the potential market for the Company’s products. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company’s drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials) ,reaching agreement with our commercial partner on the timing, scope and content of development activities for additional drug candidates, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, the Company’s ability to obtain additional financing if necessary and unanticipated research and development and other costs. For further information regarding these and other risks related to the Company’s business, investors should consult the Company’s filings with the Securities and Exchange Commission.
Pain Therapeutics, Inc.
CONTACT: Carney Duntsch, Senior Manager of Investor Relations of BurnsMcClellan, +1-212-213-0006, for Pain Therapeutics, Inc.; or Christi Waarichof Pain Therapeutics, Inc., +1-650-825-3324, or cwaarich@paintrials.com
Web site: http://www.paintrials.com/
