MethylGene Inc.
TSX : MYG

MethylGene Inc.

December 07, 2006 07:30 ET

MethylGene Selects Multi-Targeted Kinase 'c-MET' Clinical Candidate for Oncology

- Oral, Small Molecule Inhibitor with a Unique Spectrum in Hotly Pursued Area of Cancer Drug Development - IND Expected by Year End 2007

MONTREAL, QUEBEC--(CCNMatthews - Dec. 7, 2006) - MethylGene Inc. (TSX:MYG), today announced the selection of MGCD265 as the initial clinical candidate from its multi-targeted (c-MET) kinase program. MGCD265 targets the c-MET, VEGFR1, VEGFR2, VEGFR3, Tie-2 and Ron receptor tyrosine kinases, which appear to play key roles in tumor development and blood vessel formation (angiogenesis) and tumor survival.

The c-MET target has become one of intense scientific and pharmaceutical interest because of its direct involvement in tumor cell survival and angiogenesis. In addition, there is strong evidence that c-MET levels are associated with poor prognosis in several major solid tumor types.

MethylGene expects to file an Investigational New Drug (IND) application for MGCD265 by year end 2007, with Phase I clinical trials to commence thereafter, potentially in tumor types in which c-MET has been shown to be overexpressed, such as non-small cell lung cancer (NSCLC), ovarian, head and neck, gastric, colorectal, breast, leukemias, multiple myeloma or hereditary papillary renal cell cancer.

Previously disclosed preclinical data regarding our lead compounds demonstrated potent, broad spectrum, oral antitumor activity with no associated body weight loss or marrow suppressive effects. In addition, MGCD265 has demonstrated good pharmacokinetic properties in vivo. The compound also appears favorable to comparator molecules in several preclinical in vivo studies including Pfizer's approved kinase inhibitor, Sutent® and its Phase I (c-MET) inhibitor PF-2341066, as well as AstraZeneca's multi-targeted kinase compound Zactima™ which is in human clinical trials. The Company intends to present additional preclinical data at future scientific meetings.

"With the selection of MGCD265, our multi-targeted (c-MET) clinical candidate, we have again validated our research capabilities. In addition, we have increased our momentum to an equally skilled development company with a diversified portfolio. We intend to focus additional resources to our small molecule kinase and histone deacetylase programs, including human clinical trials," said Donald F. Corcoran, President and Chief Executive Officer, MethylGene Inc. "After three years of intensive preclinical research, we selected MGCD265 which has a unique kinase inhibition spectrum in an area that is very exciting, relevant and hotly pursued in oncology drug development."

In addition, MethylGene is developing additional kinase inhibitors that have a different spectrum of kinase inhibition, which may be used in cancer and other indications that involve angiogenesis. The company's kinase inhibitors may also have potential to treat diseases other than cancer, such as macular degeneration and other ophthalmologic disorders. The company is currently pursuing this field of research under a non-exclusive collaboration with a Japanese pharmaceutical company.

About MethylGene

MethylGene is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics in cancer. Two cancer product candidates are currently in clinical development: MGCD0103, partnered with Pharmion Corporation and Taiho Pharmaceutical Co., Ltd., and MG98, partnered with MGI Pharma, Inc. MethylGene has an exclusive license agreement with Merck & Co. for the development and commercialization of small molecule beta-lactamase inhibitors to overcome antibiotic resistance. MethylGene has partnered its non-oncology HDAC program for neurodegenerative diseases with EnVivo Pharmaceuticals. MethylGene has a portfolio of preclinical programs for its multi-targeted kinase and histone deacetylase (HDAC) inhibitors for both oncology and non-oncology indications, and continues to seek partnering opportunities in these areas. 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 MG98; 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 and MG98. 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 2005, under the heading "risk factors," 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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