SAN MATEO, Calif., May 5, 2009 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), announced the initiation of another clinical study for PTI-188, an investigational drug intended to treat a lethal form of skin cancer called metastatic melanoma (MM). This study follows the release of promising data in an earlier Phase I study for PTI-188, published at the Meeting of the Society for Nuclear Medicine.
"No drug therapy exists today to eliminate this cancer," said Remi Barbier, president & chief executive officer of Pain Therapeutics. "I am encouraged by our progress with PTI-188 and believe earlier results indicate PTI-188 may play a significant role in improving survival for patients with MM."
About the Study Design
This is an open-label, Phase I, dose-escalation study for PTI-188. The primary objective of this study is to assess the safety, pharmacokinetics and anti-tumor activity of PTI-188 in MM patients. Twelve or more cancer patients with confirmed MM will receive a single intravenous dose of PTI-188. Metastatic tumors will be evaluated at baseline, post-treatment and monthly thereafter until disease progression. Patient enrollment is currently underway in Israel. This study is expected to be completed later this year.
About PTI-188
PTI-188 is a monoclonal antibody (PTI-6D2) labeled with a radio-isotope (188-rhenium). This antibody binds to extracellular (but not intracellular) melanin released during tumor cell turnover; the radio-isotope is intended to deliver a cytotoxic dose of radiation to local tumor sites, thus promoting anti-tumor activity. For more information, please see http://www.paintrials.com/publications/PNAS.pdf. Pain Therapeutics holds exclusive, worldwide commercial rights to PTI-188.
About Metastatic Melanoma
Metastatic melanoma is a lethal form of skin cancer. According to the American Cancer Society, nearly 8,000 people die annually from MM in the United States. If diagnosed early and surgically removed, early-stage melanoma is potentially curable. However, the advanced form of this cancer, or MM, has a poor prognosis and limited treatment options. MM patients have a median survival time of 9 months and a 5-year survival rate of about 3%. There has been little change in these results in the past 25 years.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to REMOXY(tm), a unique abuse-resistant controlled-release oxycodone, the Company has three drug candidates in clinical programs, including PTI-188, PTI-202 and PTI-721. Pain Therapeutics is also working on a new treatment for patients with hemophilia.
For more information, please visit www.paintrials.com.
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"). Pain Therapeutics 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, expected timing of completion of clinical trials; and the ability of PTI-188 to improve the survival rate for metastatic melanoma patients and other potential benefits of the Company's drug candidates. 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 and testing of PTI-188, unexpected adverse side effects or inadequate therapeutic efficacy of PTI-188 (including the risk that current and past results of clinical trials and non-clinical testing are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company's intellectual property or trade secrets, the potential for competitive products and therapies that may be developed by others. 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.