Maxim Pharmaceuticals Announces Publication of Ceplene Phase 3 Trial Results in Journal of Clinical Oncology
SAN DIEGO--(BW HealthWire)--Jan. 9, 2002--Maxim Pharmaceuticals (Nasdaq:MAXM - news; SSE:MAXM) today announced that the results from its Phase 3 clinical trial of Ceplene(TM) and interleukin-2 (IL-2) in the treatment of advanced metastatic melanoma have been published by the leading clinicians from the trial in the January 2002 edition of the Journal of Clinical Oncology (JCO).
The clinicians concluded that the use of Ceplene (histamine dihydrochloride) as an adjunct to IL-2 is safe, well tolerated, and associated with a statistically significant prolongation of survival compared with IL-2 alone in metastatic melanoma patients with liver involvement.
The article was entitled ``Results From a Randomized Phase III Study Comparing Combined Treatment With Histamine Dihydrochloride Plus Interleukin-2 Versus Interleukin-2 Alone in Patients With Metastatic Melanoma'' (J Clin Oncol 2002; 20(1): 125-133). The authors of the publication included clinical investigators from the Melanoma Center of the University of Pittsburgh Cancer Institute, Bowyer Oncology Center, University of California at Los Angeles, John Wayne Cancer Institute, Sidney Kimmel Cancer Center, University of California, Irvine Comprehensive Cancer Center, Karmanos Cancer Institute, Washington University, The Melanoma Center of St. Louis, Oncology/Hematology Associates of Kansas City, University of Colorado, University of Arizona Cancer Center, University of Miami Sylvester Cancer Research Center, Department of Virology, University of Goteborg, and Department of Surgery, Umea University.
A total of 305 advanced metastatic melanoma patients participated in a U.S., open-label, parallel group, controlled, multi-center Phase 3 trial designed to evaluate whether Ceplene improves the efficacy of IL-2, an immunotherapeutic agent already approved for the treatment of advanced metastatic melanoma. In addition to the JCO publication, the Ceplene Phase 3 melanoma data were also selected for presentation in 2001 at the World Health Organization 5th World Conference on Melanoma, the American Society of Clinical Oncology (ASCO), and the European Cancer Conference. The JCO publication reports the 12-month data from the Phase 3 study, and the company expects that the 24-month data from the study will be published in the future.
Malignant melanoma is the most deadly form of skin cancer, and is one of the fastest-growing cancers in the developed world, particularly among younger patients. There are more than 100,000 new cases of melanoma and 15,000 deaths from the disease each year in the United States, Europe and Australia. Advanced metastatic melanoma with liver metastases is a deadly disease that has a critical need for more effective therapies, and patients have a median survival of less than five months.
Ceplene Overview
A substantial body of research suggests that the immune system's ability to destroy virally infected or cancer cells is suppressed by oxygen free radicals released by certain immune cells, a process commonly referred to as oxidative stress. Oxidative stress, implicated in numerous diseases, causes tissue damage and can damage or destroy the liver in patients with hepatitis and other chronic liver diseases. In the case of cancer and hepatitis, the oxygen free radicals also induce apoptosis (programmed cell death) in human natural killer (NK) cells, T cells, and liver-type NK/T cells, all of which are critical immune cells with the ability to kill cancerous or virally infected cells.
Ceplene, based on the naturally occurring molecule histamine, prevents the production and release of oxygen free radicals, thereby reducing oxidative stress. Accordingly, treatment with Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissue, including immune cells. By preventing the production and release of oxygen free radicals, Ceplene may protect the NK, T, and liver-type NK/T cells. For the treatment of hepatitis and cancer, Ceplene is administered in combination with cytokines such as interferon and IL-2, proteins that stimulate these same immune cells.
Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,300 patients have participated in the company's completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and hepatitis. Maxim's research and development programs are designed to provide hope to patients most in need by developing safe and effective product candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
In addition to Ceplene, Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. Lastly, the company's MaxDerm(TM) technology is designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, the apoptosis modulator compounds and MaxDerm, and regarding the company's clinical trials. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that the company will not obtain approval to market its products, the risk that clinical trials may not commence when planned, and the risks associated with the dependence upon collaborative partners. These factors and others are more fully discussed in the company's periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the company.
Editor's Note: This release is also available on the Internet at maxim.com.
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Contact:
Maxim Pharmaceuticals
Larry G. Stambaugh, Chairman, President and CEO /
Dale A. Sander, Chief Financial Officer
858/453-4040
or
Burns McClellan
Stephanie Diaz, 415/352-6262 (Investors) /
Kathy Jones, Ph.D., 212/213-0006 (Media) |
