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METHYLGENE SELECTS HISTONE DEACETYLASE ANTIFUNGAL CLINICAL CANDIDATE
– Oral, Small Molecule, Fungal-Specific Inhibitor to be Combined with Azoles to Overcome Fungal Infections that are Resistant or Insensitive to Treatment -
– IND Expected in Mid-2008 –
Montreal, Quebec. May 17, 2007 - MethylGene Inc. (TSX: MYG), today announced the selection of MGCD290 as the clinical candidate emanating from its histone deacetylase (HDAC) antifungal program.
MGCD290 targets and inhibits fungal HDACs which are believed to cause resistance or insensitivity to triazoles and terbinafine, two commonly used classes of drugs to treat human fungal infections. Many azole-resistant or insensitive fungal infections have a significantly high mortality rate in hospitalized and immunocompromised patients. Previously disclosed MGCD290 preclinical data demonstrated that the molecule synergizes and potentiates azole activity both in vitro and in vivo against key fungal pathogens such as Aspergillus and various Candida species.
MethylGene will commence manufacturing of the molecule in order to support investigational new drug (IND)-enabling studies. The Company expects to file an IND application for MGCD290 in mid-2008, with Phase I clinical trials to commence thereafter.
“With the selection of MGCD290 as a clinical candidate, we have continued to demonstrate the potential utility of our isoform-selective HDAC inhibitors, not only in cancer but also in other diseases,” said Donald F. Corcoran, President and Chief Executive Officer of MethylGene. “Our goal is to file an IND in mid-2008 and commence Phase I trials to evaluate the safety and pharmacokinetic profile of our compound. In these trials, MGCD290 will be combined with a commonly used azole in order to enhance the ability of the azole to fight serious fungal infections. We believe this may be a significant market opportunity to enhance treatment with azoles in humans who are fighting fungal infections.”
MethylGene will report additional preclinical MGCD290 data in two poster presentations at the American Society of Microbiology Conference in Toronto from May 21 to 25, 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 (in combination with azoles to overcome resistance), Huntington's disease and 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 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 or MGCD265; the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD0103 or MGCD265, 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 or MGCD265. 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.
Investor Relations Contacts:
Rhonda Chiger
Rx Communications Group, LLC
Phone: 917-322-2569
rchiger@rxir.com
Donald F. Corcoran
President & CEO
MethylGene Inc.
Phone: 514-337-3333 ext. 373
mctavishk@methylgene.com
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