MethylGene Inc.

MethylGene Inc.

June 04, 2012 09:15 ET

MethylGene Presents MGCD265 Data at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting

MONTREAL, CANADA--(Marketwire - June 4, 2012) - MethylGene Inc. (TSX:MYG) today announced that clinical data for its Met/VEGFR multi- kinase inhibitor MGCD265 was presented in a poster session at the 2012 ASCO Annual Meeting held in Chicago, Illinois. The poster, entitled "MGCD265, a multitargeted oral tyrosine kinase receptor inhibitor of Met and VEGFR: Dose-escalation Phase I study" (Abstract #3039) provided an interim update on the monotherapy trial 265-101.

Trial 265-101 is an ongoing Phase I, multicenter, open-label trial. In this trial patients are treated with MGCD265 alone, dosed orally every day over a 21 day cycle. Data was presented on 57 patients with advanced metastatic or unresectable solid malignancies that were refractory to standard therapy and/or unlikely to derive clinical benefit from existing therapies.

In an ex vivo system designed to assess the biological activity of MGCD265 using plasma samples from study patients, increased plasma concentration of MGCD265 was associated with inhibition of Met phosphorylation in a dose-dependent manner, suggesting coverage of the biological target, Met, in the clinical setting.

Stable disease was observed in 23 patients (of a total of 57 enrolled). No objective responses were observed to date. MGCD265 continues to be well-tolerated. Adverse events were mostly mild to moderate at all doses tested. The most frequent treatment-related adverse events (all grades) included diarrhea, anorexia, nausea, fatigue and vomiting. Seven (7) treatment-related grade 3 events were reported and of these, 3 were considered dose-limiting: fatigue, pituitary hemorrhage and elevated lipase. All dose limiting events occurred in cycle 1 at daily doses ≥ 250 mg/m2.

"The safety profile of MGCD265 continues to be favorable at exposures that show pharmacodynamic and biological effect", said Dr. Rachel Humphrey, Executive Vice President and Chief Medical Officer of MethylGene Inc. "We continue to be excited about the potential for MGCD265, both as a monotherapy and in combination with other anti-cancer agents." Dose escalation continues in trial 265-101 and final data will be presented at a future medical meeting. A series of expansion cohorts is planned when the maximum tolerated dose is determined.

About MGCD265

MGCD265 is a novel, oral 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 one Phase 1/2 combination clinical trial (with erlotinib and docetaxel) 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 our other programs; the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD265, MGCD290 or our other products, 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 or MGCD290. 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 expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in MethylGene's expectations with regard thereto of any change in events, conditions or circumstances on which any such statements are based except in accordance with law.

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