MethylGene Inc.

MethylGene Inc.

January 28, 2008 07:30 ET

MethylGene Reports MGCD0103 Clinical Data at the 2008 Gastrointestinal Cancers Symposium

Data from Phase I/II MGCD0103 combination trial with Gemzar® in patients with solid tumors Phase II portion of the clinical trial in pancreatic cancer patients ongoing

MONTREAL, QUEBEC--(Marketwire - Jan. 28, 2008) - MethylGene Inc. (TSX:MYG), along with its collaborator Pharmion Corporation (NASDAQ:PHRM), today updated clinical data from the Companies' MGCD0103 Phase I/II combination trial with Gemzar® (Trial 006). The data were presented in a poster session at the 2008 Gastrointestinal Cancers Symposium in Orlando.

In the poster entitled "Phase I/II Trial of the Oral Isotype-Selective Histone Deacetylase Inhibitor MGCD0103 in Combination with Gemcitabine in Patients with Solid Tumors," Emily Chan, MD, Vanderbilt University Medical Center and an investigator for this trial, described Phase I results for 25 patients and Phase II results for four patients (n equals 29). In the Phase I portion of the study, patients received an oral dose of MGCD0103 three times per week in 28-day cycles at escalating doses ranging from 50mg to 110mg. Gemzar® was administered at the standard dose and schedule of 1,000mg/m2 once per week for three weeks followed by one week of rest. The maximum-tolerated dose (MTD) was defined and the Phase II portion of the study is ongoing with a dose of 90mg of MGCD0103 in patients with pancreatic cancer. Results demonstrated MGCD0103 and Gemzar® can be administered together at the recommended doses.

Of the 29 patients enrolled in the study, 14 from the Phase I portion were evaluable for efficacy at the time of analysis. In summary, of the 14 evaluable patients there were two partial responses, two unconfirmed partial responses and six stable disease (per RECIST criteria, a partial response (PR) is a 30 percent or more decrease in the sum of the longest diameters of target lesions).

The two PRs were observed in pancreatic cancer patients. These two patients remain on study and have been on study for nine and six cycles respectively. The unconfirmed PRs were in cutaneous T-cell lymphoma and head and neck cancer patients. For the six patients with stable disease, one patient with lung cancer achieved a decrease in tumor shrinkage of 27.6 percent. This patient has been on study for six cycles and treatment is ongoing. In addition, in the subset of six evaluable patients with pancreatic cancer, there were two PRs, three stable disease and one progressive disease.

The 90mg dose currently used for MGCD0103 in this combination trial is approximately the single-agent dose for MGCD0103 that is under investigation in other Phase II trials in hematologic malignancies. The most common toxicities noted in patients from either drug alone or the combination of the two drugs were fatigue, nausea and vomiting. The most common grade 3 or greater toxicities were fatigue (n equals 10), nausea (n equals 3) and deep vein thrombosis (n equals 3). The most frequently reported hematological toxicities included anemia, thrombocytopenia and neutropenia. Enrollment of pancreatic patients continues in the Phase II portion of this trial.

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's lead product, MGCD0103, is an oral isotype-selective HDAC inhibitor presently in multiple Phase I/II and Phase II clinical trials for solid tumors and hematological malignancies, including combination trials with Vidaza®, Gemzar® and Taxotere®. MGCD265 is an oral kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene has several preclinical programs: MGCD290 an HDAC inhibitor in combination with azoles for fungal infections; an HDAC program for Huntington's disease; and a sirtuins program for cancer. MethylGene's development and commercialization partners include Pharmion Corporation, Taiho Pharmaceutical 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 impact of unilateral decisions and/or strategies of our collaborators; the results of clinical trials; the ability to demonstrate pharmacokinetic / bioequivalency; 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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