MethylGene Inc.

MethylGene Inc.

November 09, 2006 06:00 ET

Data From MethylGene's Oncology Programs to be Reported at the 18th EORTC-NCI-AACR Cancer Symposium in Prague

MONTREAL, QUEBEC--(CCNMatthews - Nov. 9, 2006) - MethylGene Inc. (TSX:MYG), today announced that clinical data from one of its Phase I trials (Trial 002) for its histone deacetylase (HDAC) inhibitor, MGCD0103, as well as preclinical data for its lead c-MET, multi-targeted kinase inhibitor, will be presented at two poster sessions at the 18th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics," in Prague, Czech Republic, on November 7th to 10th.

The HDAC inhibitor poster, "Phase I Study of Isotype-Selective Histone Deacetylase (HDAC) Inhibitor MGCD0103 Given as a Three-Times Weekly Oral Dose in Patients with Advanced Solid Tumors," describes additional results regarding MGCD0103, an oral isotype-selective HDAC inhibitor for cancer, in 37 patients with advanced solid tumors treated at doses of 12.5, 20, 27, 36, 45 and 56 mg/m2. The data show seven patients, with renal, lung, prostate and colorectal tumor types, have had stable disease beyond two cycles. Preliminary pharmacodynamic data further support that MGCD0103 can inhibit HDAC activity in a dose-dependent manner and induce histone acetylation in peripheral blood cells. Both of these effects have been shown to persist for 72 hours following dosing.

"We continue to be encouraged by the clinical results of MGCD0103 in advanced cancer patients. The PK, PD and safety profile demonstrated, to date, of our isotype-specific compound appears favorable to other company's HDAC compounds and we have embarked on both Phase II single agent and combination trials. In addition, we plan to expand our 002 trial to allow twice weekly dosing in patients with advanced solid tumors in order to provide us, potentially, with additional dosing flexibility in our later stage clinical trials," commented Donald F. Corcoran, President and Chief Executive Officer of MethylGene.

The preclinical poster, "Characterization of Lead c-MET Multi-targeted Kinase Inhibitor and Discovery of Novel c-MET/Ron Selective Inhibitors," describes the company's lead multi-targeted (c-MET) kinase inhibitor as well as its novel dual (c-MET/Ron) selective inhibitors. The company's lead multi-targeted inhibitor, which targets c-MET, three VEGF receptors, Tie-2 and Ron, showed potent, broad spectrum oral antitumor activity with no associated body weight loss or marrow suppressive effects and no observable gross toxicity. In addition, the molecule demonstrated good pharmacokinetic properties in vivo. The company expects to select a clinical candidate by the end of 2006.

Mr. Corcoran further commented, "We are also pleased to present additional preclinical data for our next cancer program, an oral, small molecule, c-MET multi-targeted kinase inhibitor. This area, similar to HDAC's is a very exciting, relevant and hotly pursued area of oncology drug development. Once again, our research efforts appear to have produced a competitive molecule. We expect to select a proprietary clinical candidate, soon, with the goal to file an IND during the fourth quarter of 2007 and move the compound into Phase I human clinical trials."

The company also disclosed its novel small molecule inhibitors with dual selectivity for c-MET and Ron receptor tyrosine kinases. These molecules potently inhibit c-MET and Ron dependent effects in cell-based assays. More importantly, these molecules potently suppress the growth of tumor cells in which c-MET or Ron are activated. The molecules are orally available and have favorable pharmacokinetics in vivo.

About MGCD0103, an Oral HDAC Inhibitor

MGCD0103 is a rationally designed, oral, isotype-specific histone deacetylase (HDAC) inhibitor. In addition to the clinical trial noted above, MethylGene and Pharmion continue to enroll patients in a Phase I single-agent trial evaluating MGCD0103 on a twice weekly oral schedule (Trial 004); a Phase I/II combination trial with demethylating agent Vidaza® (azacitidine for injectable suspension, marketed by Pharmion) in patients with advanced myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML) (Trial 005); a Phase I/II trial in combination with Gemzar® (gemcitabine HC1; Eli Lilly and Company) in solid tumors and pancreatic cancer (Trial 006); a Phase II single-agent trial in patients with refractory or relapsed diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (Trial 008); and a Phase II single-agent trial in patients with refractory or relapsed Hodgkin's lymphoma (Trial 010). The Companies previously completed enrollment in three Phase I trials (Trials 001, 002, 003) with MGCD0103 in solid tumors or MDS/AML and expect to embark on additional single-agent and/or combination trials in solid and hematological cancers.

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 (c-MET) 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

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 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 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 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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