MethylGene Inc.

MethylGene Inc.

October 25, 2006 16:15 ET

MethylGene Initiates Phase I/II Combination Clinical Trial with its Proprietary HDAC Inhibitor, MGCD0103, and Gemzar'R' in Patients with Pancreatic Cancer

MONTREAL, QUEBEC--(CCNMatthews - Oct. 25, 2006) - MethylGene Inc. (TSX:MYG), along with its partner Pharmion Corporation (NASDAQ:PHRM), today announced the initiation of a Phase I/II clinical trial (Trial 006) evaluating its isotype-specific histone deacetylase (HDAC) inhibitor product candidate, MGCD0103, in combination with Gemzar® (gemcitabine HC1; Eli Lilly and Company) in patients with solid tumors, including pancreatic cancer. Gemzar is an approved chemotherapy, marketed for use in pancreatic, non-small cell lung, breast and ovarian cancers.

In the Phase I portion of this open-label trial, MGCD0103 will be given orally, three times per week for four weeks in combination with Gemzar, which will be administered intravenously once per week for three weeks out of four in patients whose cancers are eligible to be treated with Gemzar, or patients who have no available standard of care. Key objectives for this portion of the study will be to evaluate the compatibility and safety of administering these two agents together, to determine the maximum tolerated dose of MGCD0103 and to define the Phase II dose to be administered in this combination. Secondary objectives include determining the dose-limiting toxicities, objective responses, time to progression, survival, and the pharmacodynamic and pharmacokinetic characteristics. In the expanded Phase II portion of the trial, the primary objective is to determine the overall response rate in pancreatic cancer patients. The trial may enroll up to 60 patients at cancer centers in North America. The trial is expected to take 18 to 24 months to complete.

"There continues to be a tremendous need for improved therapy for pancreatic cancer patients. The outcome of treatment with chemotherapies that are standard of care remains relatively poor," said Dr. Robert E. Martell, Vice President and Chief Medical Officer of MethylGene. "MGCD0103 has been shown in preclinical studies to enhance several chemotherapeutic agents including Gemzar. We believe that adding MGCD0103, an oral agent, to Gemzar may be a promising approach to improving the therapeutic options for patients suffering from pancreatic cancer. Furthermore, since Gemzar is used in a variety of malignancies such as non-small cell lung, ovarian, bladder and breast cancer, this study may open the way for future studies in these indications as well."

"We are pleased to be participating in this trial of gemcitabine plus MGCD0103," commented Dr. Herbert Hurwitz, Associate Professor of Medicine, Clinical Director of the Phase I Program and Co-leader, GI Oncology Program, Duke University Medical Center and a principal investigator for this trial. HDACs have been implicated in many malignant processes. MGCD0103 has shown significant activity in preclinical models, especially in combination with gemcitabine in pancreatic cancer. This clinical study will help build additional understanding of the role of HDAC inhibitors, such as MGCD0103, in the treatment of cancer."

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 syndrome (MDS) or acute myelogenous leukemia (AML) (Trial 005); 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 combination trials in solid and hematological cancers.

About Pancreatic Cancer

The pancreas is an organ in the abdomen that produces insulin and other hormones and is also responsible for producing enzymes that assist in the digestion of food. Severity of the cancer is dependent on whether the cancer is localized in the pancreas and can be removed or whether it has spread within the pancreas or metastasized to other organs. Three types of treatment exist: surgery, radiation therapy, and chemotherapy with the course of treatment being dependent on the stage of disease.

The American Cancer Society predicts that in 2006 approximately 33,730 people in the U.S. will be newly diagnosed with pancreatic cancer and about 32,300 patients will die of the disease. Pancreatic cancer is the fourth leading cause of cancer death. The 1-year relative survival rate for pancreatic cancer is 24% and the 5-year survival rate is approximately 5%.

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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