Maxim Researchers Present Melanoma Clinical Results Supporting Ceplene Mechanism of Action; Data Presented at 17th Annual Meeting of Society for Biological Therapy.

Business Editors & Health/Medical Writers

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SAN DIEGO--(BUSINESS WIRE)--Nov. 11, 2002

Maxim Pharmaceuticals, Inc. (Nasdaq:MAXM)(SSE:MAXM) announced that clinical researchers presented this weekend results from a Phase 2 study in advanced metastatic melanoma patients demonstrating that combination therapy with Ceplene(TM) (histamine dihydrochloride) and interleukin-2 (IL-2) induced significant and measurable increases in the number and function of key activated immune cells that are known to target cancer cells. Advanced metastatic melanoma is the most deadly form of skin cancer and one of the fastest-growing cancers in the developed world, and there is no established or proven standard of care. Maxim's drug candidate Ceplene is currently being tested in a final Phase 3 trial in advanced metastatic melanoma designed to support registration for marketing approval.

Dr. Theresa Whiteside, University of Pittsburgh Cancer Institute, Pittsburgh, and colleagues reported the results of a multi-center, Phase 2 advanced metastatic melanoma clinical study at the 17th Annual Society for Biological Therapy (SBT) Meeting in San Diego. A total of 50 patients were evaluated in the study to investigate the effect of Ceplene and IL-2 on the expression of specific cellular markers that may be associated with the function of key immune cells. Among the findings presented was that treatment with a combination of Ceplene and IL-2 significantly increased the expression of CD3 zeta in T cells and Natural Killer (NK) cells, white blood cells with anti-cancer properties. CD3 zeta expression is emerging as a potential biomarker of immune cell function in patients with cancer. Treatment with Ceplene and IL-2 also resulted in a decrease in the production of IL-6, a pro-inflammatory cytokine associated with the down-regulation of T cells and NK cells.

In addition to the University of Pittsburgh, other research sites participating in the study were Bowyer Oncology Center, UCLA; Brown Cancer Center, University of Louisville; Sidney Kimmel Cancer Center; University of Goteborg; University of Umea, and John Wayne Cancer Institute.

"These data suggests that the Ceplene/IL-2 combination induces significant and measurable changes in the number and function of key immune cells and further supports the hypothesis that Ceplene protects T cells and NK cells from down-regulation due to oxidative stress," said Kurt R. Gehlsen, Ph.D., Maxim's Chief Scientific Officer. "The immunomodulatory benefit of Ceplene described in this study complements the substantial body of clinical results evaluated in a series of seven completed or ongoing clinical trials conducted in more than 1,000 malignant melanoma patients."

Last month, clinical researchers presented the 36-month data for the largest study of Ceplene completed to date, the U.S.-based Phase 3 trial (the "M01" trial) for the treatment of advanced metastatic melanoma. The 36-month results of the intent-to-treat population of all 305 advanced metastatic melanoma patients randomized into the trial demonstrated a statistically significant improvement in survival for patients treated with the combination of Ceplene and IL-2 (p=0.037, evaluated by comparing Kaplan-Meier survival curves using the unadjusted Log-Rank statistical method) as compared to patients treated with IL-2 alone. The rate of three-year survival for patients treated with the Ceplene/IL-2 combination was approximately two times the rate of survival for the control patients. The 36-month data also demonstrated that the Ceplene/IL-2 combination significantly increased survival in the subpopulation of advanced metastatic melanoma patients with liver metastases (p=0.003). For the liver metastases subpopulation, the rate of three-year survival for patients treated with the Ceplene/IL-2 combination was approximately six times the rate of survival for the control patients. The combination of Ceplene and IL-2 is currently being tested in a confirming Phase 3 trial (the "M0104" trial) designed to support, in combination with the results of the M01 trial, application for approval in the U.S. and other countries. These results were published last month in the Journal of Clinical Oncology (JCO) "Classic Papers and Current Comments" (Agarwala, et al. JCO; 7(3): 589-598). The Classic Papers and Current Comments publication is comprised of the major articles related to melanoma research published in the JCO over the last 20 years.

Melanoma is one of the fastest-growing cancers in the developed world with an estimated prevalence of 230,000 in the United States and 150,000 in Europe. The incidence of melanoma has more than tripled among Caucasians between 1980 and 2002. Malignant melanoma will spread to most organs, and patients with melanoma that has metastasized to their livers have an extremely poor prognosis with a life expectancy of less than five months.

Ceplene Overview

Research has shown that oxygen free radicals released by certain immune cells can suppress the immune system and damage normal tissue, a process commonly referred to as oxidative stress. Oxidative stress, implicated in numerous diseases, is most pronounced in the liver and can damage or destroy liver tissue in patients with hepatitis and other chronic liver diseases.

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. Accordingly, treatment with Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissues, including the liver.

In addition to advanced metastatic melanoma, Ceplene is also currently being tested in a Phase 3 clinical trial for the treatment of acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of chronic hepatitis C and advanced renal cell carcinoma. More than 1,500 patients have participated in the Company's 17 completed and ongoing clinical trials in cancer and hepatitis C. Ceplene research and clinical results have 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 journals. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) 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's researchers have identified a series of novel cancer drug candidates that are potent inducers of apoptosis, or programmed cell death. The compounds were identified through Maxim's proprietary, high-throughput screening technology that uses a unique live cell screening assay. Maxim has screened approximately 1 million compounds using its screening technology and has identified drug candidates with unique mechanisms of actions that target major cancers such as breast, lung, prostate, and colorectal. The Company's third technology platform, the MX8899 topical gel, is being tested in patients who suffer from oral mucositis and radiation dermatitis, both of which are side effects of certain cancer therapies.

This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy, safety and intended utilization of Ceplene, the apoptosis inducers, and MX8899, and the conduct, results and timelines associated with 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, and the risk that the Company will not obtain approval to market its products. These factors and others are more fully discussed in the Company's periodic reports and other filings with the Securities and Exchange Commission.

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