MAXIM PHARMACEUTICALS REPORTS PUBLICATION OF 36-MONTH MALIGNANT MELANOMA SURVIVAL DATA FOR CEPLENE(TM)

MAXIM PHARMACEUTICALS REPORTS PUBLICATION OF 36-MONTH MALIGNANT MELANOMA SURVIVAL DATA FOR CEPLENE(TM) Publication in JOURNAL OF CANCER IMMUNOLOGY AND IMMUNOTHERAPY SAN DIEGO - June 4, 2004 -- Maxim Pharmaceuticals, Inc. (Nasdaq:MAXM) (SSE: MAXM) today announced that the 36-month patient follow-up data from the M01 Phase 3 study of Ceplene(TM) (histamine dihydrochloride) as a combination therapy to treat advanced metastatic melanoma has been published electronically in an article by Hellstrand et al, for the June issue of the Journal of Cancer Immunology and Immunotherapy. The 36-month results demonstrate that 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 log-rank test) compared to patients treated with IL-2 alone. The improvement in three-year survival remained significant in the subpopulation of advanced metastatic melanoma patients with liver metastases (p=0.006). "We are pleased that the scientific and clinical community continue to recognize the results of our first phase 3 trial in advanced stage IV melanoma. Patients with this rapidly progressive disease today do not have an effective treatment option," said Dr. Kurt R. Gehlsen, Maxim's Chief Scientific Officer. "Our initial phase 3 trial remains the first large randomized clinical trial, for any new treatment, to demonstrate a survival benefit in this patient population." Ceplene Status In May 2004, the Company announced the approval of a treatment protocol in the United States allowing the Company to provide the Ceplene combination therapy to malignant melanoma patients under an expanded access program while the current Phase 3 trial is being completed. The Company expects to complete its current Phase 3 trial in melanoma patients with liver metastases this summer and amend its NDA with the results from the current Phase 3 study in late 2004. A centralized application for marketing of Ceplene therapy in malignant melanoma was filed with the European regulatory authorities in November 2003 and is currently under review. The Company also recently announced completion of a Phase 3 trial in acute myeloid leukemia, in which the combination of Ceplene plus IL-2 significantly improved leukemia free survival, the primary endpoint. The results for the primary endpoint can be see on the company's website at www.maxim.com. 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's lead drug candidate Ceplene(TM) (histamine dihydrochloride) is designed to prevent or inhibit oxidative stress, thereby reversing immune suppression and protecting critical immune cells. In November 2003, Maxim filed an application for market authorization in Europe for approval to market Ceplene for the treatment of advanced malignant melanoma. Ceplene is currently being tested in a Phase 3 cancer clinical trial for advanced malignant melanoma with liver metastasis. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxim is also developing an oral formulation of histamine for the potential treatment of chronic liver diseases. More than 2,000 patients have participated in 17 completed and ongoing clinical trials of Ceplene. In addition to Ceplene, Maxim is developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, which may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. Ceplene and the apoptosis inducers are investigational drugs and have not been approved by the U.S. Food and Drug Administration (FDA) or any international regulatory agency. 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 oral histamine formulation and the apoptosis inducers, 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. Note: The Maxim logo is a trademark of the Company. Editor's Note: This release is also available on the Internet at http://www.maxim.com. ## Contacts: Larry G. Stambaugh Aline Schimmel (Investors) Chairman, President and CEO Burns McClellan Anthony E. Altig (212) 213-0006 Chief Financial Officer Sean Collins (Media) (858) 453-4040 Valerie Bent (Media) CCG Investor Relations (818) 789-0100 ------------------------------------------------------------ Denna information skickades av Waymaker http://www.waymaker.se Följande filer finns att ladda ned: http://www.waymaker.net/bitonline/2004/06/04/20040604BIT00010/wkr0001.pdf