STOCKHOLM, Sweden and SAN DIEGO, Dec. 9, 2004 (PRIMEZONE) -- Maxim Pharmaceuticals, Inc. (Nasdaq:MAXM) (SSE:MAXM) today reported that Myriad Genetics, Inc., filed an Investigational New Drug (IND) application with the FDA for a Phase 1 clinical study of MPC-6827, a pro-apoptotic cancer therapeutic candidate identified by Myriad researchers from a family of compounds licensed from Maxim. The study is designed to evaluate the safety and pharmacokinetic profile of MPC-6827 in patients with advanced solid tumors in an escalating dose regimen. This compound family was discovered by Maxim through its proprietary live cell high-throughput caspase-3 screening technology. In pre-clinical studies, MPC-6827 demonstrated activity that was better than control using current standard-of-care chemotherapy drug in xenograft models of breast, pancreas, colon, ovary and prostate cancers.
"Myriad was extremely diligent in progressing this compound to an IND, and we remain pleased to have partnered with such an excellent organization," stated Larry G. Stambaugh, Maxim's Chairman and Chief Executive Officer. "We believe that MPC-6827 holds significant promise as an oncology drug candidate, and represents only the first candidate discovered using Maxim's screening technology that has the potential to progress to clinical trials."
MPC-6827 was identified by Myriad researchers from a family of compounds discovered by Maxim through its proprietary high-throughput screening system that identifies compounds and molecular targets that modulate programmed cell death, or apoptosis. Other lead compounds discovered by Maxim include MX2167, MX116407 and MX128504. MX2167 is a novel anticancer agent that targets the transferrin receptor leading to a previously uncharacterized rapid induction of apoptosis in preclinical tumor models. MX116407 is part of a novel class of microtubule inhibitors with vascular targeting activity and strong antitumor activity in pre-clinical in vitro and in vivo studies. MX128504 targets a novel intracellular target selective and shows selectivity for breast and colorectal cancer.
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 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, 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.
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 the Company's apoptosis compounds and 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.
Note: The Maxim logo is a trademark of Maxim. Editor's Note: This release is also available on the Internet at http://www.maxim.com.
Contacts:
Maxim Pharmaceuticals Larry G. Stambaugh Chairman & Chief Executive Officer Burns McClellan Aline Schimmel (212) 213-0006 David A. Walsey Sr. Dir. Corp. Communications (858) 453-4040
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