STOCKHOLM, Sweden, March 17, 2004 (PRIMEZONE) -- Maxim Pharmaceuticals (Nasdaq:MAXM) (SSE: MAXM) today announced that it has entered into anagreement with Shire BioChem, Inc. under which Maxim has reacquired therights to the MX2105 series of vascular targeting agent cancer drugcandidates. The MX2105 series was licensed in July 2000 to BioChemPharma, a company that was subsequently acquired by ShirePharmaceuticals. In July 2003 Shire Pharmaceuticals announced that itwas exiting the field of oncology research, creating the opportunity forMaxim to reacquire the rights to the MX2105 series of compounds.
Maxim also announced that two abstracts describing the results ofpreclinical testing of compounds within the MX2105 series have beenaccepted for presentation at the American Association for CancerResearch Annual Meeting to be held March 27th through 31st in Orlando,Florida. One of the lead compounds, MX116407, demonstratedstatistically significant anti-tumor activity and produced tumorregression as a single agent in animal lung cancer models. In addition,the combination of MX116407 and certain cytotoxic agents demonstratedstatistically significant anti-tumor activity and tumor regression, anda higher rate of complete cures than the combination of other reportedvascular targeting agents combined with cytotoxics. MX116407 is beingprepared for studies designed to support the initiation of humanclinical trials.
MX2105 was identified through Maxim's proprietary high-throughput caspase-based screening assay. In conjunction with the license Maxim and Shire BioChem collaborated on the development of the MX2105 family under a joint research agreement. As part of these efforts, Maxim's chemistry group designed and synthesized over 300 analogs within the MX2105 family to determine the structure-activity relationship and to improve pharmacological properties. Compounds within the MX2105 series have been tested in multiple tumor xenograft models and have demonstrated activity against multiple cancer types, including breast cancer, lung cancer and colorectal cancer. The new agreement calls for Maxim to pay Shire BioChem certain milestone and royalty payments upon the successful advancement of any drug candidates within the MX2105 series.
"We were pleased to have the opportunity to consolidate the rights to MX2105 series within Maxim, as this compound family complements our existing portfolio of apoptosis cancer drug candidates," said Larry G. Stambaugh, Maxim's Chairman and Chief Executive Officer. "Our research team has been successful at identifying a diverse group of compounds that induce apoptosis in cancer cells through novel mechanisms, of which the MX2105 series is one example."
Multiple U.S. and international patents and patent applications encompass the composition of matter and use of MX116407 and other analogs within the MX2105 series. The MX2105 series is one of more than 40 compound families identified by Maxim through its proprietary caspase- based high-throughput screening system that targets the identification of compounds that modulate programmed cell death, or apoptosis.
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 Phase 3 cancer clinical trials for advanced malignant melanoma with liver metastasis and acute myeloid leukemia. 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, including MX116407, 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, including MX2105 and MX116407, 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, the risks associated with dependence upon key personnel, 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.
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