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MethylGene Reports Interim Clinical Results for MGCD0103.

MONTREAL -- MethylGene Inc. (TSX:MYG) a biopharmaceutical company, today announced interim results regarding MGCD0103, its isotype) International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia on November 14, 2005. Ongoing clinical data for MGCD0103 in solid tumours demonstrated prolonged disease stabilization in three patients with the most significant side-effect being reversible fatigue. Of particular note, is the apparent lack of significant hematological and cardiac side effects with MGCD0103. Data disclosed at the conference included the chemical structure of MGCD0103, the specific HDAC isoforms targeted by MGCD0103, the synergistic antitumour activity of MGCD0103 combined with gemcitabine in pancreatic and lung cancer models in vivo, and the synergistic anticancer activity of MGCD0103 with interferon alpha in multiple myeloma cell lines.

Interim Clinical Results for Ongoing MGCD0103 Phase I Solid Tumour Trial

Data below were reported in two poster presentations: "Phase I Study of Isotype-Selective Histone Deacetylase (HDAC) Inhibitor MGCD0103 Given as Three-Times Weekly Oral Dose in Patients with Advanced Solid Tumours" (Poster C77) and "Pharmacodynamic Assessment of MGCD0103, a Novel Isotype-Specific HDAC Inhibitor, in Preclinical Evaluations and in Phase I Trials." (Poster C216).

Rationale: MGCD0103 is a novel isotypic-selective inhibitor of the enzyme histone deacetylase (HDAC). HDAC inhibitors act by turning on tumour suppressor genes that have been inappropriately turned off. Tumour suppressor genes are a natural defense against cancer. It is therefore hypothesized that specifically inhibiting those HDACs involved in cancer with MGCD0103 may restore normal cell function and reduce or inhibit tumour growth.

Method: MGCD0103 is administered orally three times per week for 2 weeks every 3 weeks in patients with solid tumours.

Results: The Company reported on the first 26 patients with 22 of these patients having received prior chemotherapy, radiotherapy, and/or immunotherapy. Primary tumour types investigated were colorectal (7), kidney (5), lung (3), and others (11). MGCD0103 has been well tolerated with the most common side effect (smaller or equal to Grade 3) in the first 22 patients being fatigue. Other side effects included nausea and vomiting, anorexia and constipation (all smaller or equal to Grade 2). Prolonged stabilization of disease was observed in two kidney cancer and one colorectal cancer patient. The half-life of MGCD0103 was determined to be 9 hours, as previously reported. Pharmacodynamic data revealed prolonged HDAC inhibition at 48 hours after a single dose in some patients.

Status: The maximum tolerated dose has not yet been reached and patient enrolment continues at a dose of 45 mg/m2.

In addition, the Company disclosed that the structure of MGCD0103 which isa di-hydrobromide salt of a substituted 2-aminophenyl benzamide - a non-hydroxamate, inhibiting HDAC isoforms 1, 2, 3 and 11 as described in Poster C216.

MGCD0103 has Synergistic Activity with Gemcitabine

As described in Poster C220, entitled, "Synergistic Antitumor Activity of the Isotype-Selective Histone Deacetylase Inhibitor MGCD0103 in Combination with Gemcitabine," MGCD0103, in combination with gemcitabine, has been shown in pancreatic and lungcancer models in mice to impede tumour growth without increased toxicity. Conclusions from these data are that MGCD0103 in combination with gemcitabine may be a valuable therapeutic strategy against pancreatic or lung cancer.

MGCD0103 has Synergistic Activity with Interferon Alpha in Multiple Myeloma Cell Lines

As described in Poster A172, "Epigenetic Regulation of IFNs Activity in Multiple Myeloma by the Isotype-Selective HDAC Inhibitor MGCD0103," the combination of MGCD0103 with interferon alpha synergistically induced apoptotic death of multiple myleoma (MM) cell lines.

About MethylGene

MethylGene is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics in cancer and infectious disease. Two cancer product candidates are currently in clinical trials: MGCD0103, partnered with Taiho Pharmaceutical for certain Asian countries, and MG98, partnered with MGI Pharma for North America.

MGCD0103 is currently in Phase I dose-escalation monotherapy trials against solid tumours and hematological malignancies and also in a Phase I/II combination trial with azacitidine. MG98 has entered a randomized two-step Phase II combination trial with interferon alpha in metastatic renal cell cancer. 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 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 MethylGene's website at

Except for historical information, this news 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 can be found in the Company's Annual Information Form dated December 31, 2004, and can be found on 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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Comment:MethylGene Reports Interim Clinical Results for MGCD0103.
Publication:Business Wire
Geographic Code:1CANA
Date:Nov 15, 2005
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