MethylGene Inc.

MethylGene Inc.

November 14, 2011 08:00 ET

MethylGene Reports Clinical Data for MGCD265 at the 2011 AACR-NCI- EORTC Molecular Targets and Cancer Therapeutics Conference

MONTREAL, QUEBEC--(Marketwire - Nov. 14, 2011) - MethylGene Inc. (TSX:MYG) announced that it has presented results for the Company's Phase 1 clinical trial (Trial 265-102), in which MGCD265 was administered as a single agent on an intermittent schedule in patients with advanced disease that was refractory to standard therapy. MGCD265 is the company's proprietary oral Met/VEGF receptor tyrosine kinase inhibitor. The trial results were presented on Sunday, November 13, 2011 in a poster session at the 2011 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics held in San Francisco, California.

"We are pleased that MGCD265, when dosed in an intermittent (week on, week off) schedule, was very tolerable for patients and showed early signs of clinical benefit," commented Dr. Jeff Besterman, Chief Scientific Officer of MethylGene. "The excellent tolerability of MGCD265 in this intermittent schedule was consistent with the continuous dose regimens used in Trials 265-101 and 265-103. We continue to enroll patients in Trials 265-101 and 265-103, and we will report additional data from these ongoing studies in 2012."

Poster Session

"The Determination of the Maximum Tolerated Dose (MTD) of MGCD265 on an Intermittent Schedule: Phase I Study Results (Study 265-102)" Abstract #A95.

Forty-seven patients were enrolled in this Phase 1, open-label, dose-escalation study to evaluate the safety and MTD of oral MGCD265 as a single agent when dosed intermittently. MGCD265 was administered daily (one week on, one week off) to patients with a variety of advanced solid malignancies for 28–day cycles. There were no treatment-related serious adverse events (SAEs). The most frequent treatment- related adverse events were diarrhea, fatigue and nausea, and most were of modest severity (grade 1 or 2). Dose-limiting toxicities were grade 3 mood alteration and grade 3 fatigue in one patient, and grade 3 hemoptysis in another patient. The MTD in this single agent study was determined to be 128 mg/m2 twice daily (BID). In this group of patients with advanced disease treated with MGCD265, 4 had prolonged stable disease (6-14 cycles).

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 been well-tolerated, either alone or in combination, and has shown preliminary signs of clinical activity.

About the Met Target

The Met receptor is a protein that is found on the cell's surface. When not properly regulated (i.e. over active) it plays a key role in the growth, survival and metastasis of various types of cancers. Met is also involved in angiogenesis and is strongly associated with major cancers such as non-small cell lung, gastric, prostate and triple negative breast carcinomas.

About MethylGene

MethylGene Inc. (TSX:MYG) is a clinical-stage biopharmaceutical company that develops novel therapeutics for cancer and infectious disease. The Company's lead product candidates include: MGCD265, an oral Met/VEGF receptor kinase inhibitor that is in Phase 1/2 clinical trials for solid tumor cancers, and MGCD290, a fungal Hos2 inhibitor, for use in combination with fluconazole for fungal infections, which has completed Phase 1 clinical studies and will start randomized Phase 2 trials in the near term. The Company's partners include Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and EnVivo Pharmaceuticals, Inc.

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 for the fiscal year ending December 31, 2010, 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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