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Biotech / Medical : MAXM: Maxim Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: SemiBull who wrote (14)	5/22/2002 7:57:10 PM
From: SemiBull	Read Replies (1) \| Respond to of 35

Maxim Announces Results From Phase 2 Clinical Study of Ceplene in the Treatment of Advanced Kidney Cancer Ceplene Study Results Presented at American Society of Clinical Oncology Meeting SAN DIEGO--(BW HealthWire)--May 22, 2002-- Maxim Pharmaceuticals Inc. (Nasdaq\NM:MAXM)(SSE:MAXM) announced at the 38th meeting of the American Society of Clinical Oncology (ASCO) results from a controlled Phase 2 trial of its lead drug candidate Ceplene(TM) in combination with interleukin-2 (IL-2) for the treatment of metastatic renal cell carcinoma, a deadly cancer of the kidneys. In the 41-patient Phase 2 study, advanced metastatic renal cell carcinoma patients were treated with a combination of Ceplene and IL-2, while patients in the control group were treated with the same dose of IL-2 alone. For the group of patients treated with the Ceplene/IL-2 combination, 42 percent achieved a partial response or disease stabilization compared to 26 percent for the group treated with IL-2 alone. Patients treated with the Ceplene/IL-2 combination achieved a median response duration of 11.7 months compared to 7.3 months for the patients treated with IL-2 alone. The study was led by Dr. Mark R. Middleton, Christie Hospital NHS Trust, Manchester, England. In addition to the response results, the researchers also reported that Ceplene did not significantly affect the toxicity profile of IL-2 in this study. There are approximately 30,800 new cases annually of renal cell carcinoma in the United States. Metastatic renal cell carcinoma often is resistant to radiation therapy and chemotherapy, and the disease results in more than 12,100 deaths each year. A second study of Ceplene in renal cell carcinoma was the subject of a presentation at the ASCO conference. Dr. Frede Donskov, Department of Oncology, Aarhus University Hospital and Institute of Medical Microbiology and Immunology, University of Aarhus, Aarhus, Denmark presented research entitled "Association of Intratumoral and Peripheral Blood Lymphocyte Subsets to Objective Response and Survival in Patients with Metastatic Renal Cell Carcinoma (mRCC) Undergoing Interleukin-2 based Immunotherapy." This study provides novel in vivo evidence of the possible contribution of lymphocyte subsets, specifically Natural Killer (NK) and cytotoxic T cells, to tumor reduction seen in responding patients during immunotherapy with the Ceplene/IL-2 combination. The two renal cell studies were among the five studies of Ceplene presented by researchers this week or accepted as abstracts at the ASCO meeting in Orlando, Florida. Ceplene Overview Research has shown that oxygen free radicals released by certain immune cells such as monocytes can suppress the immune system and damage normal tissue, a process commonly referred to as oxidative stress. Ceplene, based on the naturally occurring molecule histamine, has been shown in preclinical work to prevent the production and release of oxygen free radicals, thereby reducing oxidative stress. In the case of cancer and hepatitis, oxygen free radicals may induce apoptosis (programmed cell death) in NK cells and T cells, both of which are critical immune cells with the ability to kill cancerous or virally infected cells. By preventing the production and release of oxygen free radicals, Ceplene may protect NK and T cells. For the treatment of hepatitis and cancer, Ceplene is administered in combination with cytokines such as interferon-alpha and interleukin-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 liver diseases. Maxim's research and development programs are designed to offer hope to patients by developing safe and effective therapeutic 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. The company is also developing MaxDerm(TM), a technology platform 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 technology 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, and the risk that clinical trials may not commence when planned. 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. -------------------------------------------------------------------------------- Contact: Maxim Pharmaceuticals Inc. Larry G. Stambaugh or Dale A. Sander, 858/453-4040 or Burns McClellan Stephanie Diaz (Investors), 415/352-6262 or Coffin Communications Group Valerie Bent (Media), 818/789-0100