MethylGene Inc.
TSX : MYG

MethylGene Inc.

September 19, 2007 13:15 ET

MethylGene Presents Preclinical Data for its Clinical Candidate MGCD290, an Antifungal Histone Deacetylase Inhibitor

- Data Presented at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Demonstrates Synergy of MGCD290 with Antifungal Agents in Clinical Isolates from Invasive Fungal Infections - Investigational New Drug (IND) Expected Mid-2008

MONTREAL, QUEBEC--(Marketwire - Sept. 19, 2007) - MethylGene Inc. (TSX:MYG), today announced preclinical results for its histone deacetylase (HDAC) clinical candidate MGCD290 at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held in Chicago.

In a poster session entitled "Synergy of MGCD290, a Histone Deacetylase Inhibitor, with Azole Antifungals Tested Against Clinical Isolates of Candida and Aspergillus," Daniel J. Diekema, M.D., Associate Professor (Clinical) of Medicine and Pathology at the University of Iowa Carver College of Medicine, presented the synergistic in vitro activity of MGCD290 against human fungal clinical isolates of Candida and Aspergillus species when administered with the antifungal agents voriconazole, fluconazole and itraconazole (azoles). Many of the azole-resistant clinical isolates had their azole sensitivity shifted from a therapeutically untreatable range to a treatable range.

Forty-five invasive (bloodstream) clinical isolates of Candida were tested, including nine resistant to voriconazole and 16 resistant to fluconazole. MGCD290 demonstrated synergy against 37 of the 45 isolates (82 percent) when combined with voriconazole and against 34 of the 45 species (76 percent) when combined with fluconazole. In addition, in all 14 C. glabrata species tested, nine of which were fluconazole-resistant, synergy occurred at MGCD290 concentrations of lesser or equal to 0.5 microns g/mL.

Of the 16 Aspergillus species tested, MGCD290 demonstrated synergy with both voriconazole and itraconazole against 11 of the 16 (69 percent) isolates tested. No in vitro antagonism was ever observed with the various MGCD290-azole combinations.

Therefore, MGCD290 has been shown to demonstrate synergy with azoles against the majority of the clinical isolates of Candida and Aspergillus species tested, including azole-resistant isolates.

About MGCD290

MGCD290 is an oral, small molecule histone deacetylase (HDAC) inhibitor that appears to target fungal HDACs preferentially to human HDACs. MGCD290 potentiates and broadens the spectrum of azole activity against human fungal pathogens, including azole-resistant isolates. Treatment with azoles, a commonly used class of drugs for fungal infections, often results in the emergence of resistant fungal strains, thereby rendering the azole treatment ineffective over time. It is believed that the fungi may become resistant to azole treatment through the action of certain fungal HDAC isoforms. These isoforms affect expression of key fungal genes that allow the organism to develop resistance to azoles. The demand for effective antifungals is driven by a rising incidence of immunocompromised patients including individuals with cancer who are receiving chemotherapy treatment; therefore a successful antifungal drug could be used as part of a supportive cancer care treatment.

About Fungal Infections

Fungal infections are often treated with a class of drugs called azoles. Infections caused by certain Candida and Aspergillus species can be especially difficult to manage medically. Aspergillosis has a high mortality rate in immunocompromised patients. In 2005, the market for antifungal medicines generated almost US $4 billion worldwide.

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 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 programs: MGCD290 an HDAC inhibitor in combination with azoles for fungal infections; an HDAC program for Huntington's disease; a sirtuins program for cancer; and a beta-lactamase program to overcome antibiotic resistance. MethylGene's development and commercialization partners include Pharmion Corporation, Taiho Pharmaceutical and EnVivo Pharmaceuticals. 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 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 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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