MethylGene Inc.

MethylGene Inc.

June 04, 2007 15:00 ET

MethylGene Reports Phase I Data on MGCD0103 in Advanced Leukemias and Myelodysplastic Syndrome (Trial 004) at ASCO

Update on Additional Clinical Trials with MGCD0103

MONTREAL, QUEBEC--(Marketwire - June 4, 2007) - MethylGene Inc. (TSX:MYG), along with its collaborators Pharmion Corporation (NASDAQ:PHRM) and Taiho Pharmaceutical Co. Ltd. (Tokyo, Japan), today provided an update on its clinical trials with its lead oncology product candidate MGCD0103, a novel isotype-selective histone deacetylase (HDAC) inhibitor. Data for this compound was recently presented at the 43rd American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Trial 004 Presented at ASCO

In a poster session entitled, "A Phase I Study of MGCD0103 given as a Twice Weekly Oral Dose in Patients With Advanced Leukemias or Myelodysplastic Syndrome (MDS)," (Abstract #2516, Trial 004), Jeffrey E. Lancet, M.D., principal investigator and Assistant Professor at the H. Lee Moffitt Cancer Center & Research Institute, presented data for a Phase I MGCD0103 single-agent, dose escalation study in leukemias and myelodysplastic syndrome (MDS). Twenty-four patients were enrolled with a median age of 72 years. Estimated half-life in plasma is 10 hours. Inhibition of HDAC activity was still present three to four days after a dose of MGCD0103, suggesting continuous pharmacodynamic activity with twice weekly dosing. The investigators concluded that MGCD0103 can be safely administered on a twice weekly schedule, continuously for prolonged duration to patients with hematological malignancies (MDS, AML, ALL). The maximum tolerated dose (MTD) in this patient population on this schedule was confirmed at 66 mg/m2 with fatigue being the dose-limiting toxicity. Enrollment is complete for this trial.

Updates on Other MGCD0103 Clinical Trials

Trial 006

In this Phase I/II MGCD0103 trial in combination with Gemzar® in solid tumors, dose escalation and patient enrollment continue. MGCD0103 is administered orally three times per week for four weeks in combination with Gemzar®. Gemzar® is administered intravenously once per week for three weeks.

Trial 007

This is a Phase II single-agent MGCD0103 trial in myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) patients, including elderly AML patients. MGCD0103 is administered orally three times per week.

Trial 008

This trial is a Phase II single-agent MGCD0103 trial in diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma. Objective clinical activity has been documented. MGCD0103 is administered orally three times per week. Enrollment continues and is expected to be completed at year end 2007. MethylGene expects to present preliminary data at upcoming scientific conferences in 2007.

Trial 009

A Phase II single-agent MGCD0103 trial in a hematologic malignancy indication is expected to commence by July 2007.

Trial 011

A combination trial with MGCD0103 in solid tumors is expected to commence by August 2007.

About MethylGene

MethylGene Inc. (TSX:MYG) is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company focuses on some of the most promising areas of oncology such as histone deacetylase (HDAC) and kinase inhibitors. The Company's lead product is MGCD0103, an oral isotype-selective HDAC inhibitor presently in multiple clinical trials for solid tumors and hematological malignancies, including Phase II monotherapy and Phase I/II combination trials with Vidaza® and Gemzar®. MGCD265 is an oral kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene has several preclinical HDAC programs in non-oncology indications such as fungal infections (clinical candidate MGCD290 in combination with azoles to overcome resistance) and Huntington's disease. The company also has a beta-lactamase program to overcome antibiotic resistance. MethylGene's development and commercialization partners include Pharmion Corporation, Taiho Pharmaceutical, Merck 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, 2006, under the heading 'risk factors,' the final prospectus filed on February 23, 2007, 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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