MethylGene Inc.

MethylGene Inc.

April 02, 2012 09:00 ET

MethylGene Presents Preclinical Data for MGCD265 at the American Association for Cancer Research (AACR) Annual Meeting

Data Supports Ongoing Clinical Combination Studies with EGFR inhibitors

MONTREAL, QUEBEC--(Marketwire - April 2, 2012) - MethylGene Inc. (TSX:MYG) today disclosed preclinical data during a presentation for its proprietary multi-targeted kinase inhibitor, MGCD265, at the 2012 AACR Annual Meeting held in Chicago, Illinois.

Results were presented showing the potent inhibition of tumor growth by the combination of MGCD265 with erlotinib and providing additional support to the mechanisms underlying this anti-tumor effect. This combination was more effective than either erlotinib alone or MGCD265 alone resulting in tumor regression in a pre-clinical model of gastric cancer. Gene expression analysis revealed that pathways impacted by this drug combination included inhibition of cell growth, induction of apoptosis and regulation of glycolysis. The expression of glycolysis-regulating genes was partly downregulated by either MGCD265 or erlotinib alone. However, the combination led to a significant depression of regulators of glycolysis, including the key mediator hexokinase 2 (HK2). The poster is entitled "The Combination of MGCD265, a Met/VEGFR Inhibitor in Clinical Development, and Erlotinib Potently Inhibits Tumor Growth by Altering Multiple Pathways Including Glycolysis," (abstract no. 1790).

The observation that the glycolysis pathway is inhibited by the combination of MGCD265 with erlotinib reinforces the rationale of combining MGCD265 with EGFR inhibitors in clinical trials. The ability of cancer cells to alter their metabolism in order to grow more rapidly has been recognized for many years. The expression and activity of enzymes in the glycolysis pathway is modified to allow for uncontrolled growth of the tumor. This pathway has recently emerged as an interesting target for oncology drug development.

These results support the ongoing clinical development of MGCD265 in combination with EGFR inhibitors as an anti-cancer therapy. Early results from clinical trials investigating MGCD265 in combination with erlotinib have demonstrated encouraging signs of activity in gastric cancer patients. An update on clinical activities of MGCD265 is anticipated at a future medical meeting.

Science Policy Session

In a separate Science Policy session at the AACR meeting: "Scientific and Regulatory Challenges in Codevelopment of Predictive In Vitro Diagnostics", Dr. Rachel Humphrey, Chief Medical Officer of MethylGene Inc., will give an oral presentation entitled "Biomarkers in clinical development: Strategic considerations". The presentation will be held at McCormick Place South (Level 1), Room S103.

About MGCD265

MGCD265 is a novel, orally active small molecule inhibitor that targets a unique spectrum of receptor tyrosine kinases: Met, VEGFR 1, 2, and 3, Tie-2 and RON. These kinases play key roles in tumor development, survival and metastasis as well as the inappropriate formation of blood vessels (angiogenesis) that nourish the tumor. MGCD265 has completed one Phase 1 single agent study, and is nearing completion of one Phase 1 single agent clinical trial and two Phase 1/2 combinations, one with docetaxel and one with erlotinib in solid tumors.

About MethylGene

MethylGene Inc. (TSX:MYG) is a small molecule drug development company that is advancing two novel therapeutics for cancer and infectious disease in human clinical trials. The Company's lead product candidates are: MGCD290, an oral antifungal agent targeting the fungal Hos2 enzyme, that is currently in Phase 2 trials for vulvovaginal candidiasis and MGCD265, an oral Met/VEGF receptor kinase inhibitor that is in Phase 1/2 clinical trials for solid tumor cancers. MethylGene owns all rights to its lead product candidates, and has partnerships with Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and EnVivo Pharmaceuticals, Inc. for its other pipeline programs.

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management of MethylGene, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond MethylGene's control. These risks and uncertainties could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such results, performance or achievements include, but are not limited to, the timing and effects of regulatory action; the continuation of collaborations; the results of clinical trials; the timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD265, MGCD290 or mocetinostat (MGCD0103); the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD265, MGCD290 or mocetinostat, and the relative success or the lack of success in developing and gaining regulatory approval and/or market acceptance for any compound or new product including MGCD265, mgcd290 or mocetinostat. Such risks include, but are not limited to, the impact of general economic conditions, economic conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which MethylGene does business, stock market volatility, fluctuations in costs, expectations with respect to our intellectual property position and our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others, changes in the competitive landscape including changes in the standard of care for the various indications in which MethylGene is involved, and changes to the competitive environment due to consolidation, as well as other risks, as described in MethylGene's Annual Information Form under the heading "Risk Factors" which you are urged to read, and all other documents filed by the Company that can be found at Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance on the forward-looking statements included in this presentation. These statements speak only as an update on the date they are made and MethylGene is under no obligation to revise such statements as a result of any event, circumstance or otherwise except in accordance with law.

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