SAN DIEGO, Dec. 1, 2004 (PRIMEZONE) -- Maxim Pharmaceuticals (Nasdaq:MAXM) (SSE:MAXM) announced today the publication of two manuscripts in the Journal of Molecular Cancer Therapeutics (Mol Cancer Ther 2004 3: pp. 1365-1374 and 1375-1384) describing Maxim's MX116407 anticancer drug candidate as part of a novel class of microtubule inhibitors with vascular targeting activity. The manuscripts characterize MX116407 as a potent caspase activator with strong antitumor activity in pre-clinical in vitro and in vivo studies. MX116407 appeared highly effective in mouse tumor models, producing tumor necrosis at doses that correspond to only 25% of the maximum tolerated dose. Moreover, in combination treatment, MX116407 significantly enhanced the antitumor activity of the chemotherapeutic agent cisplatin, resulting in tumor-free animals.
``The results from these studies establish MX116407 as the lead candidate from this family of novel microtubule inhibitors. The antitumor activity demonstrated by MX116407 holds potential for the treatment of a wide range of cancers, and strongly supports its continued development as a novel anticancer agent for human use. This is one of four lead candidates the company has discovered and these data again validate the potential of our proprietary screening technology and chemical genetics capabilities to identify potential novel cancer drugs," stated Ben Tseng, PhD, Maxim's Senior Director of Research.
Maxim Apoptosis Modulator Discovery Platform
Cancer is a group of diseases characterized by uncontrolled cellular growth (e.g., tumor formation). One reason for unchecked growth in cancer cells is the disabling, or absence, of the natural process of programmed cell death called apoptosis. Apoptosis is normally triggered to destroy a cell from within when it outlives its purpose or it is seriously damaged. One of the most promising approaches in the fight against cancer is to selectively induce apoptosis in cancer cells, thereby checking, and perhaps reversing, the improper cell growth.
Maxim researchers can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells through the use of chemical genetics and our proprietary live cell high-throughput caspase-3 screening technology. Chemical genetics is a research approach investigating the effect of small molecule drug candidates on the cellular activity of a protein, enabling researchers to determine the protein's function. Using this approach with its proprietary caspase-3 screening technology, Maxim researchers can focus their investigation on the cellular activity of small molecule drug candidates and their relationship to apoptosis. The narrow focus on apoptosis is achieved by screening for the activity of caspase-3, an enzyme with an essential role in cleaving other important proteins necessary to cause cell death through apoptosis. This combination, of chemical genetics and Maxim's screening technology, allows researchers to discover and rapidly test the effect of small molecules on pathways and molecular targets crucial to apoptosis, and gain insights into their potential as new anticancer agents.
Maxim's screening technology is also particularly versatile since it can adapt its assays for almost any tumor type that can be cultured, and it can measure caspase activation inside multiple cell types (e.g. cancer cells, immune cells, brain cells, cells of the endocrine system, or cell lines from different organ systems or genetically engineered cells). This allows Maxim researchers to find potential drug candidates that are selective for specific cancer types, which may help identify candidates that provide increased therapeutic benefit and reduced toxicity.
Maxim's high-throughput screening capabilities allow researchers to screen approximately 30,000 compounds per day. To date, this program has identified several families of compounds with potentially novel mechanisms that induce apoptosis in cancer cells. Four compounds from within these families have progressed to lead drug candidate status with proven pre-clinical efficacies in tumor models and identified molecular targets. The most advanced of these compounds was licensed to Myriad Pharmaceuticals in December 2003.
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. Ceplene, Maxim's lead drug candidate, is an immune-modulator that reverses immune suppression and protects critical immune cells. Because Ceplene modifies basic immune functions, it has the potential to be used in a range of diseases. Additionally, Maxim is developing small-molecule apoptosis modulators for cancer, cardiovascular disease and degenerative diseases.
Ceplene and the apoptosis compounds are investigational drugs and have not been approved by the U.S. Food and Drug Administration 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 conduct and results of the Company's clinical trials, and the Company's plans regarding regulatory filings, future research and 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 or later clinical trials, the risk that the Company will not obtain approval to market its products, and the risks associated with the Company's reliance on outside financing to meet its capital requirements. 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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