MethylGene Inc.

MethylGene Inc.

August 15, 2008 15:32 ET

MethylGene Provides Update on Suspension of New Enrollment in MGCD0103 Clinical Trials

MONTREAL, QUEBEC AND SUMMIT, NEW JERSEY--(Marketwire - Aug. 15, 2008) - MethylGene Inc. (TSX:MYG) today announced that as a result of the internal voluntary suspension of enrollment of new patients into clinical trials evaluating MGCD0103, MethylGene and its development partner, Celgene Corporation, have been informed by the U.S. Food and Drug Administration (FDA) that the agency concurs with the action and is concomitantly placing a partial clinical hold on new patient enrollment for MGCD0103 clinical trials as it awaits the companies' submission of data and action plan to mitigate risk for patients.

A partial clinical hold is a delay or suspension of only part of the clinical work requested under the investigational new drug (IND) application (e.g., a specific protocol or part of a protocol is not allowed to proceed; however, other protocols or parts of the protocol are allowed to proceed under the IND). Under the partial clinical hold, patients currently enrolled in MGCD0103 clinical trials who are confirmed to have no signs or symptoms of pericarditis or pericardial effusion may continue in their respective studies.

The companies had already begun to establish an action plan and data analysis package to submit to the FDA. The action plan with risk mitigation steps will be communicated to regulatory agencies and clinical investigators. Some of the steps are expected to include specific guidance for identifying patients at potential risk as well as management of patients who may develop pericarditis / pericardial effusion while undergoing treatment with MGCD0103. MethylGene and Celgene are working closely together with the FDA to complete this package and communicate it with the FDA to obtain approval to commence enrollment of new patients as soon as possible.

About MGCD0103

MGCD0103 is an orally-administered, isoform-selective HDAC inhibitor. The compound is currently in multiple clinical trials: a Phase I trial in combination with Taxotere® for solid tumors; two Phase I/II trials, the first in combination with Vidaza® for hematological malignances and the second with Gemzar® for pancreatic cancer; several Phase II monotherapy trials in hematological malignancies and, more recently, a Phase II, three-arm combination trial with Vidaza in hematological malignancies. MGCD0103 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and has been designated an orphan medicinal product by the European Medicines Agency (EMEA) for the treatment of Hodgkin lymphoma and AML.

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

About Celgene

Celgene Corporation, based in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's 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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