Maxim Pharmaceuticals Announces Publication of Ceplene Phase 3 Quality of Life Results in Supportive Care in Cancer
Thursday June 12, 3:00 am ET
Research Supporting Mechanism of Action Also Published in Trends in Immunology
SAN DIEGO--(BUSINESS WIRE)--June 12, 2003-- Maxim Pharmaceuticals (Nasdaq NM: MAXM, SSE: MAXM) announced the publication of quality-of-life results from the U.S. Phase 3 clinical trial of its lead drug candidate Ceplene(TM) (histamine dihydrochloride) in the treatment of advanced metastatic melanoma. As part of the multi-center, randomized Phase 3 "M01" trial, an independent health outcomes assessment group compared the quality-of-life effects of combination treatment with Ceplene and IL-2 versus IL-2 alone for patients with advanced metastatic melanoma. The researchers concluded that treatment with the combination of Ceplene and IL-2 resulted in a significant increase in median quality-adjusted survival versus treatment with IL-2 alone for the intent-to-treat population of all patients randomized into the trial (p=0.007, Mann-Whitney U-test) and also for the population of patients with baseline liver metastases (p=0.011). These results were published by leading clinicians from the trial in the medical journal Supportive Care in Cancer (11(5):304-312).
"These published results are important as they suggest that the survival benefit associated with Ceplene in the Phase 3 trial was achieved without adversely affecting patient quality of life," said Sanjiv S. Agarwala, M.D., a principal investigator in the trial and Associate Medical Director of the Melanoma Center at the University of Pittsburgh Cancer Institute. "These results are all the more important given that some of the available treatments for metastatic melanoma, such as higher dose regimens of IL-2, have a high incidence of toxic side effects necessitating in-patient hospitalizations. Our experience in treating patients with Ceplene to date is that this drug candidate can be safely administered by patients at home and is well tolerated."
Advanced metastatic melanoma is the most deadly form of skin cancer and the fastest-growing cancer in the developed world, and there is no established or proven standard of care for the treatment of this life-threatening disease. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any international regulatory agency. Ceplene has been tested in six completed clinical trials for melanoma in more than 800 patients, and is currently being tested in a final Phase 3 trial designed to support U.S. FDA registration for marketing approval.
The publication of quality-of-life results complements last year's publication of the 24- and 36-month efficacy and safety results from the M01 Phase 3 trial in the Journal of Clinical Oncology (JCO, Vol 20, No 1, 2002) and in the JCO "Classic Papers and Current Comments" (Vol 7, No 3, 2002). The Classic Papers and Current Comments publication represents a selection of key articles related to melanoma research published in the JCO over the last 20 years. The 24 and 36-month results from the M01 Phase 3 trial suggested that for the intent-to-treat population of all 305 advanced metastatic melanoma patients randomized into the trial a statistically significant improvement in survival was demonstrated for patients treated with the combination of Ceplene and IL-2 compared to patients treated with IL-2 alone.
The mechanism of action of Ceplene is also the subject of a new publication in Trends in Immunology (Vol 24, No 5, 2003). In "Melanoma Immunotherapy: A Battle Against Radicals?" Dr. Kristoffer Hellstrand, Department of Virology, University of Goteborg, describes research delineating Ceplene's role in protecting key immune cells by reversing oxidative stress. Research regarding histamine, the active agent underlying Ceplene, and related clinical results has been the subject of more than 80 presentations at major scientific and clinical meetings, and have been published in more than 300 scientific and clinical articles.
The combination of Ceplene and IL-2 is currently being tested in a Phase 3 trial (the "M0104" trial) designed to support, in combination with the results of the M01 trial, marketing approval in the U.S. and other countries. The FDA reviewed and accepted the protocol for the M0104 Phase 3 trial under its "Special Protocol Assessment" procedures and has confirmed that it will consider the trial to be an adequate and well-controlled study if conducted in accordance with the protocol. The Company currently plans to file an application for approval to market Ceplene for the treatment of advanced metastatic melanoma in Europe in late 2003. |
