MethylGene Inc.

MethylGene Inc.

June 12, 2008 07:30 ET

MethylGene Initiates Second Phase I Clinical Trial With MGCD265, A Multi-Targeted (c-Met) Kinase Inhibitor in Patients With Solid Tumors

MONTREAL, QUEBEC--(Marketwire - June 12, 2008) - MethylGene Inc. (TSX:MYG), today announced the dosing of the first patient in a Phase I clinical trial evaluating MGCD265 in solid tumors (Trial 101). This is the second Phase I trial with the compound which is being evaluated on different dosing schedules.

In this dose-escalating Phase I trial using a modified 3+3 design, MGCD265 is administered orally to patients at an initial starting dose of 24 mg/m2 daily on a continuous basis for a 21-day cycle. The purpose of this trial is to evaluate the safety, pharmacokinetics, pharmacodynamics, and the maximum tolerated dose of MGCD265 in patients with advanced metastatic or unresectable solid tumors that are refractory to standard therapy. Clinical sites for this trial include the Dana-Farber Cancer Institute in Boston, the BC Cancer Agency in Vancouver and Duke University Medical Center in Durham.

The Company previously announced the commencement of a Phase I trial with MGCD265 (Trial 102) in the same patient population using an initial starting dose of 24mg/m2 daily on an intermittent schedule of every other week for a 28-day cycle. This trial is being conducted at the Karmanos Cancer Institute in Detroit and at the MD Anderson Cancer Center in Houston.

"We are pleased to be participating in this MGCD265 trial," commented Dr. Christian Kollmannsberger, medical oncologist at the BC Cancer Agency and an investigator for this trial. "MGCD265 is being administered to cancer patients for whom approved therapies have been ineffective. There are several approved kinase inhibitors on the market, but we are seeing the need for novel multi-targeted kinase inhibitors that simultaneously target different cancer pathways. MGCD265 appears to target various pathways involved in tumor development and angiogenesis. We are looking forward to the results for this Phase I trial."

"We continue to make progress with our pipeline, which now includes two potential anticancer agents currently in clinical trials. In addition to our multi-targeted c-Met kinase inhibitor, MGCD265, our histone deacetylase inhibitor, MGCD0103, is also in clinical trials," said Donald F. Corcoran, President and Chief Executive Officer of MethylGene Inc. "MGCD0103, partnered with Celgene and Taiho, is in multiple trials as a monotherapy and in combination with approved anticancer agents. We are also proceeding with IND-enabling studies for MGCD290, our HDAC inhibitor for fungal infections which remains on course for a regulatory filing in the late third quarter of this year in order to commence a Phase I clinical trial in healthy volunteers. With this progress, we and/or our partners expect to have a number of compounds in clinical trials during 2008 - all of which have emanated from our in-house research capabilities."

About MGCD265

MGCD265 is an oral, small molecule, multi-targeted kinase inhibitor that targets c-Met, VEGFR1, VEGFR2, VEGFR3, Tie-2 and Ron receptor tyrosine kinases. These kinases appear to play key roles in tumor development, tumor survival and the inappropriate formation of blood vessels (angiogenesis) that nourish the tumor. MGCD265 is currently in two Phase I clinical trials in solid tumor cancers.

About MethylGene

MethylGene Inc. (TSX:MYG) is a publicly-traded, clinical stage, biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's lead product, MGCD0103, is an oral, isoform-selective HDAC inhibitor presently in multiple clinical trials for solid tumors and hematological malignancies, including Phase II monotherapy and Phase I, Phase I/II and Phase II combination trials with Vidaza®, Gemzar® and Taxotere®. MGCD265 is an oral, multi-targeted kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases and is in Phase I clinical trials for solid tumor cancers. In addition, MethylGene's preclinical programs include: MGCD290, an HDAC inhibitor used in combination with azoles for fungal infections, a kinase inhibitor program for ocular diseases, and a sirtuin inhibitor program for cancer. MethylGene's development and commercialization partners include Celgene Corporation, Taiho Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd. and EnVivo Pharmaceuticals. Please visit our website at

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 MGCD0103, MGCD265 or MGCD290; the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD0103, MGCD265 or MGCD290, 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 MGCD0103, 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, which you are urged to read, as described in MethylGene's Annual Information Form for the fiscal year ending December 31, 2007, under the heading 'risk factors,', 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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