View Full Version : Pain Therapeutics Cleared To Initiate Phase I Study In Metastatic Melanoma

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03-31-2007, 06:01 AM
Pain Therapeutics, Inc. (Nasdaq: PTIE) announced today it has received approval from the Ministry of Health in Israel to begin human testing of a new treatment for metastatic melanoma, a deadly form of skin cancer.

Pain Therapeutics' initial Phase I study is designed to evaluate the pharmacokinetics of a proprietary radio-labeled monoclonal antibody in patients diagnosed with metastatic melanoma. The Company expects to initiate this first-in-human Phase I study in a limited number of patients in Q2 2007 across several major academic medical centers in Israel.

"It is common knowledge that patients with this type of cancer have limited treatment options," said Nadav Friedmann, Ph.D., MD, chief operating and medical officer of Pain Therapeutics. "We hope the evaluation of this agent in the clinic replicates the promising activity we saw in preclinical studies."

Pain Therapeutics continues to expect its net cash requirements for 2007 to be approximately $10 million, inclusive of program expenses related to metastatic melanoma. At December 31, 2006 the Company's cash, cash requirements and marketable securities were $204.4 million.

About Metastatic Melanoma

Melanoma is a deadly form of skin cancer. According to the American Cancer Society, melanoma accounts for approximately 5% of all skin cancers but causes about 75% of all skin cancer-related deaths. An estimated 60,000 people will be diagnosed and nearly 8,000 people will die from melanoma in 2007 in the U.S. alone. If diagnosed and surgically removed, early-stage melanoma is potentially curable. However, for patients with metastatic melanoma, the prognosis is poor, with limited available treatments and a median survival time of 8.5 months and a 5-year survival rate of 3%. There has been little change in these results in over 25 years. The incidence of melanoma has increased more rapidly than any other cancer during the past 10 years. The last drug to treat patients with melanoma was approved by the FDA 30 years ago.

About Pain Therapeutics, Inc.

Pain Therapeutics is a biopharmaceutical company that develops novel drugs for pain management and oncology. We have three investigational drug candidates in clinical programs. Remoxy(TM) and PTI-202 are proprietary, abuse-resistant forms of opioid drugs. Oxytrex(TM) is a novel, next-generation painkiller that potentially offers less physical dependence than currently marketed opioid painkillers. We are also developing a novel radio-labeled monoclonal antibody to treat metastatic melanoma, a rare but deadly form of skin cancer. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. For more information, please visit our website at http://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, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, including metastatic melanoma, the potential benefits of the Company's drug candidates, including metastatic melanoma, the Company's plan to initiate a clinical study in metastatic melanoma in Q2 2007, the Company's expected net cash requirements in 2007 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 and testing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company's intellectual property or trade secrets 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.