MONTREAL, CANADA--(Marketwire - Oct. 18, 2011) -MethylGene Inc. (TSX:MYG) today announced that it has received approval for its initial Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to start a Phase 2 clinical trial for MGCD290, its oral Hos2 fungal inhibitor, in patients with acute vulvovaginal candidiasis (AVVC), more commonly known as vaginal yeast infection. This trial (290-005) will enroll approximately 200 women with moderate to severe AVVC and is expected to start enrolling patients by year end.

"The FDA's acceptance of our IND represents an important milestone for this program, and we look forward to announcing the start of randomized, placebo-controlled, Phase 2 clinical trials for MGCD290 in the near future," said Charles Grubsztajn, President and Chief Executive Officer of MethylGene. "We expect to report data from this first study in 2012, and to start a second Phase 2 trial with MGCD290 in recurrent vulvovaginal candidiasis in the new year."

About MGCD290

MGCD290 targets the fungal Hos2 enzyme and was designed to be co-administered with azoles, in particular fluconazole, to potentiate and enhance activity against fungal infections. In preclinical studies, MGCD290 in combination with fluconazole increased cidality and broadened the spectrum of azole activity in vitro against human fungal pathogens, including azole-resistant clinical isolates such as Candida glabrata (Pfaller, M. et al., Journal of Clinical Microbiology, Dec 2009).

About the Phase I Program for MGCD290

The Company has completed four Phase 1 clinical trials in over 100 healthy adult volunteers evaluating MGCD290 both as a single-agent and in combination with fluconazole. These trials were performed in Canada under a clinical trial application (CTA) by Health Canada's Therapeutic Products Directorate. Data from these randomized, placebo-controlled Phase 1 studies demonstrated excellent safety when MGCD290 was administered either as a single agent or in combination with fluconazole, as well as linear pharmacokinetics with no observed drug-drug interactions.

About Vulvovaginal Candidiasis (VVC)

Vulvovaginal candidiasis (VVC) is a yeast infection that is most commonly caused by the type of fungus known as Candida albicans, although Candida glabrata is thought to be the cause of 10-15% of infections. VVC affects an estimated 75% of healthy women at least once and 40-45% will have two or more episodes within their lifetime. A single dose of fluconazole is approved for acute VVC and is considered effective in the mildly symptomatic population, but in women with moderate to severe infections fluconazole is ineffective in up to 50% of patients. Despite the medical need, few agents are currently in development.

About MethylGene

MethylGene Inc. (TSX:MYG) is a clinical-stage biopharmaceutical company that develops novel therapeutics for cancer and infectious disease. The Company's lead product candidates include: MGCD265, an oral Met/VEGF receptor kinase inhibitor that is in Phase 1/2 clinical trials for solid tumor cancers and MGCD290, a fungal Hos2 inhibitor, for use in combination with fluconazole for fungal infections, which has completed Phase 1 clinical studies. The Company's partners include Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and EnVivo Pharmaceuticals, Inc.

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, 2010, 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.