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Press release from Marketwire

MethylGene Presents MGCD265 Data at the 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

Thursday, November 08, 2012

MethylGene Presents MGCD265 Data at the 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics07:00 EST Thursday, November 08, 2012MONTREAL, CANADA--(Marketwire - Nov. 8, 2012) - MethylGene Inc. (TSX:MYG) today announced that data for the clinical-stage Met/VEGFR inhibitor MGCD265, was presented at the 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, in Dublin, Ireland. In the poster entitled "A Novel Assay for the Met Inhibitory Activity of MGCD265 in Plasma From Solid Tumor Patients in a Dose Escalating Phase I Study" data was presented using an ex vivo assay, in which plasma samples from patients treated with MGCD265 were tested for the ability to inhibit Met phosphorylation in a human cancer cell line. In the ongoing clinical trials, patient plasma levels have been reached that result in ~80% inhibition of Met phosphorylation. In companion studies using a human tumor xenograft model, Met inhibitory activity in mouse plasma correlated with inhibition of Met phosphorylation in the tumor as well as dose-dependent inhibition of tumor growth. "It is encouraging that the MGCD265 exposures in patients and the accompanying level of Met inhibition are in the range at which tumor growth inhibition is observed in animal models." said Dr. Jeffrey Besterman, Chief Scientific Officer of MethylGene. About MGCD265MGCD265, a rationally designed, orally administered small molecule kinase inhibitor designed to target Met and the VEGFR 1,2, and 3 receptor tyrosine kinases (RTKs). RTKs, including Met, are key kinases involved in cancer, angiogenesis (a process whereby new blood vessels are formed to nourish the tumors), tumor cell metastasis, tumor development and survival. Met expression is elevated and associated with tumorigenesis in several solid tumor indications including NSCLC, gastric, prostate, colorectal, bladder, breast and ovarian cancers. Phase I/II studies of single agent MGCD265 and combinations with erlotinib or docetaxel are currently underway. More than 200 patients have been treated to date in clinical studies of both single-agent and combination therapy with docetaxel or erlotinib. In combination trials, six of 104 patients have been on study for over one year at a variety of doses: NSCLC (n=2), GE cancer (n=2), ovarian cancer (n=1) and chordoma (n=1). Additionally, disease control in the combination study was observed in 11/12 NSCLC patients (with two partial responses) and 4/9 patients with GE cancer (2 non-complete response/non-progressive disease). MGCD265 continues to demonstrate a favorable safety profile. Drug-related diarrhea, fatigue and lipase elevation have been observed in patients receiving MGCD265 monotherapy The maximum tolerated dose has not yet been defined and dose escalation continues.About MethylGeneMethylGene Inc. (TSX:MYG) is a drug development company that is advancing novel therapeutics for the treatment of human diseases including cancer and infectious disease. The Company's lead product candidates are: MGCD290, an oral antifungal agent targeting the fungal Hos2 enzyme that is in Phase II trials for vulvovaginal candidiasis, and MGCD265, an oral Met/VEGF receptor kinase inhibitor that is in Phase I/II 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 www.sedar.com. 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 news release. These statements speak only as of 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.FOR FURTHER INFORMATION PLEASE CONTACT: Contact Information: MethylGene Inc.Joseph Walewicz, CFAVice President, Business & Corporate Development514-337-3333 ext. 373ir@methylgene.comwww.methylgene.comThe Trout Group LLCThomas HoffmannVice President646-378-2931thoffmann@troutgroup.comwww.troutgroup.com