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MethylGene Issued Histone Deacetylase Patent-Company Provides HDAC Cancer Clinical Trial Update.

MONTREAL -- MethylGene Inc. (TSX:MYG), a biopharmaceutical company, today announced the issuance of United States patent #6,541,661 entitled "Inhibitors of Histone Deacetylase", which provides protection for compounds and methods for inhibiting histone deacetylase (HDAC) enzymes. MethylGene's proprietary isotypic selective anti-cancer HDAC inhibitor, MGCD0103, is currently advancing through two Phase I dose-escalation monotherapy clinical trials at sites in Canada and the United States in patients with advanced solid malignancies refractory to currently available therapies.

"MethylGene has developed considerable expertise and intellectual property in the field of HDAC enzyme inhibition. This patent establishes the initial protection of our HDAC franchise, which has the potential to yield therapeutics not only for cancer but for a broad range of disease indications," said Donald F. Corcoran, President and CEO of MethylGene." HDACs are a diverse family of enzymes; as such, our strategy has been to develop drugs that target specific HDAC isoforms. This approach of focusing on selective drug candidates is in many cases a proven strategy in drug development which we anticipate will increase our likelihood of success."

MGCD0103 is an orally active small molecule that selectively inhibits a specific subset of cancer-related HDAC enzymes, resulting in an activity profile that is genotypically, phenotypically and functionally distinct from indiscriminate HDAC inhibitors. In pre-clinical trials, MGCD0103 was shown to be orally available and long lasting with good pharmacokinetic and physiochemical properties. It has demonstrated activity in vitro and in vivo against a broad spectrum of human cancer types.

The human dose escalation clinical trials were initiated in April 2004 and are designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MGCD0103 when administered orally. Each trial uses a different dosing schedule, an every day oral dose or a 3 times per week oral dose, and will enroll approximately 15 to 30 patients with enrolment expected to last approximately nine to twelve months. A Phase I monotherapy trial with MGCD0103 in haematological tumours is planned for the fourth quarter of this year. Phase II trials are expected to commence during 2005.

"The level of medical interest and research activity on HDAC enzymes has grown exponentially in recent years, driven by their ability to regulate gene transcription," commented Dr. Eric Rowinsky, a principal investigator on a MGCD0103 Phase I trial and Director of the Institute for Drug Development in San Antonio, Texas. "By regulating the expression of tumour suppressor genes, HDAC inhibitors are able to block angiogenesis and cell cycling, and promote apoptosis and cellular differentiation, key factors in tumour growth. Novel isotypic selective HDAC inhibitors target a subset of the HDACs, which appear to be implicated in cancer, thus positively affecting their safety and efficacy profile."

About MethylGene

MethylGene is a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics in cancer and infectious disease. Two cancer product candidates, MG98, partnered with MGI Pharma in North America and MGCD010, partnered with Taiho Pharmaceutical for certain Asian countries, are currently in clinical trials. MG98 will enter a randomized two-step Phase II combination trial with interferon alpha in metastatic renal cell cancer in Q3 2004. MGCD0103 is currently in two Phase I dose-escalation monotherapy trials against solid tumors. In collaboration with Merck, MethylGene is developing small molecule beta-lactamase inhibitors to overcome antibiotic resistance. MethylGene has a portfolio of research programs including kinases and HDAC inhibitors for non-oncology indications such as neurodegenerative diseases to be exploited in collaboration with EnVivo Pharmaceuticals. Please visit our website at

Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
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Publication:Business Wire
Geographic Code:1CANA
Date:Jul 15, 2004
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