MethylGene Inc.
TSX : MYG

MethylGene Inc.

September 09, 2010 07:30 ET

MethylGene to Present Clinical Data at the 50th Annual ICAAC Meeting

Final Clinical Data from Completed Phase I Trials for Antifungal Agent, MGCD290, to be Reported

MONTREAL, QUEBEC--(Marketwire - Sept. 9, 2010) - MethylGene Inc. (TSX:MYG) today announced that final Phase I clinical data for its Hos2 fungal inhibitor, MGCD290, will be reported in a poster session at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Meeting which will be held from September 12th to 15th, 2010 in Boston, Massachusetts.

Data previously reported from Phase I studies have demonstrated MGCD290 to be well-tolerated in healthy adult volunteers. In addition, the compound has favorable pharmacokinetic and safety profiles when administered alone and in combination with fluconazole.

The following are the session details:

Poster Presentation

Multiple Ascending Dose Phase I Studies in Healthy Subjects Demonstrate Safety and Pharmacokinetics of MGCD290, an Oral Fungal Hos2 Inhibitor +/- Fluconazole

Presentation No.: F1-862
Poster No.: 314
Location: Hall B1
Time: Monday, September 13, 10:00 a.m. to 4:30 p.m.

About MGCD290

MGCD290 is the first in a completely novel class of small molecules that potentiates and extends the antifungal spectrum of azoles, and restores susceptibility to azole-resistant fungal pathogens. The addition of MGCD290 to fluconazole, the most widely prescribed azole, has been shown to intensify the cidality and increase the potency of fluconazole by up to 1000-fold in yeasts, molds, and dermatophytes. In addition, MGCD290 expands fluconazole's spectrum of activity and restores susceptibility to pathogens such as C. glabrata, C. krusei, and Zygomycetes which are clinically resistant to fluconazole, and cross-resistant to azoles. In preclinical and clinical studies to date, MGCD290 in combination with fluconazole has shown an excellent safety profile, linear pharmacokinetics, and no drug-drug interactions. MGCD290 may be combined with any azole, and has the potential to be administered orally, IV, and topically. As such, it has broad commercial appeal for treatment of invasive fungal infections and onychomycosis.

About MethylGene

MethylGene Inc. (TSX:MYG) is a publicly-traded, clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics with a focus on cancer. The Company's product candidates include: MGCD265, an oral, multi-targeted kinase inhibitor targeting the Met, VEGF, Ron and Tie-2 receptor tyrosine kinases that is in multiple clinical trials for cancer; MGCD290, a fungal Hos2 inhibitor for use in combination with fluconazole for serious fungal infections which has completed Phase I clinical studies; and mocetinostat (MGCD0103), an oral, isoform-selective HDAC inhibitor for cancer which has been in multiple Phase II clinical trials and is currently in a Phase II trial in refractory or relapsed follicular lymphoma. Mocetinostat is licensed to Taiho Pharmaceutical Co. Ltd in certain Asian countries. A fourth compound discovered using MethylGene's HDAC platform, EVP-0334 - a potential cognition enhancing agent for neurodegenerative diseases has successfully completed Phase I trials sponsored by EnVivo Pharmaceuticals Inc. MethylGene also has a funded collaboration with Otsuka Pharmaceutical Co. Ltd. for applications in ocular diseases using the Company's proprietary kinase inhibitor chemistry. Please visit our website at www.methylgene.com.

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, 2009, under the heading "Risk Factors" which you are urged to read and all other documents filed by the Company that can be found at www.sedar.com. 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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