SOUTH SAN FRANCISCO, Calif., Dec. 9 /PRNewswire-FirstCall/ -- Pain
Therapeutics, Inc. (Nasdaq: PTIE), 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
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.
SOURCE Pain Therapeutics, Inc.
CONTACT: Carney Duntsch, Senior Manager of Investor Relations of Burns
McClellan, +1-212-213-0006, for Pain Therapeutics, Inc.; or Christi Waarich of
Pain Therapeutics, Inc., +1-650-825-3324, or email@example.com
Web site: http://www.paintrials.com