SOUTH SAN FRANCISCO, Calif., Nov. 8 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. announced today the launch of a new antibody technology that may transform how metastatic melanoma is treated, ultimately enabling clinicians to provide effective medical treatment for this rare but deadly form of skin cancer. The Company plans to initiate a clinical program in 2007.
Historically, monoclonal antibodies have been ineffective in melanoma for technical reasons. In a new twist, scientists at Albert Einstein College of Medicine have developed a novel type of radio-labeled monoclonal antibodies that target melanoma tumor sites and deliver a short burst of lethal radiation to melanoma tumors. The specificity of this treatment ensures the destruction of the tumors without harming normal tissue. The technology, published in Proceedings of the National Academy of Science, may also have therapeutic uses outside of oncology.
Under the terms of an agreement between the Company and Albert Einstein College of Medicine (AECOM), AECOM was paid an undisclosed upfront fee and may receive milestone payments totaling approximately $3.5 million in the aggregate based on clinical and regulatory progress. AECOM will also receive a 4% royalty on net sales. In exchange, Pain Therapeutics received exclusive, worldwide commercial rights to all indications in oncology and infectious disease.
“Since the Company’s inception, our business model has stayed the same,” said Remi Barbier, president and chief executive officer of Pain Therapeutics. “We identify, in-license and translate scientific findings from academia into de novo therapeutics. Today’s announcement is an exciting extension of our business model because we think it creates an unprecedented means to address metastatic melanoma and perhaps other difficult-to-treat diseases with new therapeutic strategies. Pain is the most common symptom in patients suffering from cancer, so for us oncology is a natural horizontal expansion of our roots in pain management.”
“The survival rate is dismal for patients with metastatic melanoma,” said Nadav Friedmann, Ph.D., M.D., chief medical and operating officer of Pain Therapeutics. “People with metastatic melanoma have only one goal and that’s to stay alive. We think any technology that can extend survival for these patients has a bright future in clinical medicine.”
“The beauty of using a radio-labeled monoclonal antibody is its ability to target tumors with specificity and to deliver an effective dose of radiation that is not subject to drug resistance,” added George Ben Thornton, Ph.D., vice president of technology at Pain Therapeutics. “Since the year 2000, the FDA has approved two different radio-labeled antibodies in oncology. We think this bodes well for the future of this approach.”
About The New Technology
A research team from Albert Einstein College of Medicine, led by Arturo Casadevall, M.D., Ph.D., Chairman of the Department of Microbiology & Immunology, and Ekaterina Dadachova, Ph.D., Associate Professor, Department of Nuclear Medicine, developed a novel approach to treat metastatic melanoma based on targeting melanin, a skin pigment that is released from dead melanotic tumor cells, with radio-labeled monoclonal antibodies. The antibodies seek out the released melanin and destroy human melanoma cells with a lethal dose of ionizing radiation, thus achieving a therapeutic effect. Melanin in normal, healthy tissue is not targeted because it is inside the cells and not accessible to the radio-labeled antibody.
The feasibility of this approach was tested in a proof-of-concept animal study that was published in Proceedings of the National Academy of Sciences (PNAS) in an article titled, Dead Cells in Melanoma Tumors Provide Abundant Antigen for Targeted Delivery of Ionizing Radiation by a mAb to Melanin (PNAS 2004, 101: 14865-14870). At the start of the study, mice with human melanoma cells had tumors ranging from 0.6 to 1 cm. in diameter. Tumor growth was completely inhibited in the treated group with a single dose of radio-labeled antibodies; near total tumor regression was observed in animals with smaller initial tumors. No deaths occurred among treated mice during the 30-day study. Furthermore, treated mice showed no kidney or other organ damage. In contrast, tumors continued to grow aggressively in the control group. By day 20, all the mice in the control group died except for one. A full-text copy of this publication is available on the PNAS website: http://www.pnas.org .
Pain Therapeutics cautioned, however, that this apparent success in mice must be demonstrated in human clinical trials before the therapeutic impact of the technology can be evaluated. Pilot trials involving patients with metastatic melanoma are now being planned at university centers.
Conference Call/Webcast
Pain Therapeutics will host a conference call and webcast for the investment community today at 1:30 p.m. ET to discuss this announcement. To participate in the conference call, please dial 866-770-7129 (within the U.S.) or 617-213-8067 (outside the U.S.) fifteen minutes prior to the start of the call. The call reference number is 76195346. A playback of the conference call will be available following the live event. To access the playback, please dial 888-286-8010 (within the U.S.) or 617-801-6888 (outside the U.S.) and enter reservation number 71936385. A live webcast of the conference call will also be available online at www.paintrials.com.
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 2006 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.
More Information
For more information about melanoma, please visit the National Cancer Institute web site: http://www.cancer.gov/cancertopics/types/melanoma .
For more information about melanin as a potential target to treat melanoma, please visit: http://www.futuremedicine.com/doi/abs/10.2217/14796694.1.4.541 .
For more information on Dr. Casadevall’s research, please visit: http://www.aecom.yu.edu/home/faculty/profile.asp?id=3478&k= .
For a technical overview on the use of radio-labeled antibodies in oncology, please see: “Targeted Radionuclide Therapy For Solid Tumors: An Overview,” by Sally DeNardo and Gerald DeNardo, published 2006, in Int. Journal of Radiation Oncology, Vol. 66, No.2.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs. 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. These three drugs target different segments of the multi-billion dollar market to treat severe chronic pain, such as persistent low-back pain or pain due to advanced stages of osteoarthritis. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. For more information, please consult our website: www.paintrials.com.
Forward Looking Statements
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 new technology for metastatic melanoma, the potential benefits of the Company’s drug candidates including new technology for metastatic melanoma, the Company’s plan to initiate a clinical program in metastatic melanoma 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.
CONTACT: Christi Waarich, Senior Manager of Investor Relations of PainTherapeutics, Inc., +1-650-825-3324, or cwaarich@paintrials.com; or media,Carney Noensie of Burns McClellan, +1-212-213-0006, for Pain Therapeutics,Inc.
Web site: http://www.paintrials.com/
