MethylGene Inc.
TSX : MYG

MethylGene Inc.

October 10, 2007 07:30 ET

MethylGene and Pharmion Initiate Phase I Combination Clinical Trial With MGCD0103 and Taxotere® in Patients With Solid Tumors

MONTREAL, QUEBEC AND BOULDER, COLORADO--(Marketwire - Oct. 10, 2007) - MethylGene Inc. (TSX:MYG) and Pharmion Corporation (NASDAQ:PHRM) today announced the initiation of a Phase I clinical trial (Trial 011) evaluating MGCD0103, the Companies' isotype-selective histone deacetylase inhibitor (HDACi) product candidate, in combination with Taxotere® (docetaxel; Sanofi Aventis) in patients with solid tumors. Taxotere is an approved chemotherapy agent marketed for use in breast, lung, prostate, gastric and head and neck cancer.

In the first portion of the trial, MGCD0103 will be given orally, three times per week for three weeks in combination with Taxotere, which will be administered on Day 1 of each three-week cycle to patients with cancer where treatment with Taxotere is approved or considered standard of care, or patients who have no available standard of care therapeutic options. Key objectives for this portion of the study will be threefold: to evaluate the safety of administering these two agents together; determine the maximum tolerated dose of MGCD0103 when combined with the two fixed doses of Taxotere; and to define optimal dosing for the second portion of the trial. In the second portion of the trial, objectives include further assessment of the safety of the drug combination, quantification of tumor responses and measurement of the pharmacodynamic and pharmacokinetic characteristics. The trial may enroll up to 50 patients at cancer centers in North America. The trial is expected to take 12 to 18 months to complete.

"This is an important step forward in the clinical development of MGCD0103," said Andrew Allen, Executive Vice President and Chief Medical Officer of Pharmion Corporation. "Cytotoxic chemotherapies such as Taxotere remain the primary therapy for the treatment of most solid tumors, and we know from preclinical models that MGCD0103 is synergistic with Taxotere and could potentially sensitize and re-sensitize patients to microtubule-targeted therapy. Because MGCD0103 is an isotype-selective HDACi, rather than a broad spectrum HDACi, it targets specific isotypes likely relevant to cancer, with potential reduction in off-target toxicity. This may be particularly important as we combine MGCD0103 with cytotoxic chemotherapy."

"We are delighted to be participating in this trial of docetaxel plus MGCD0103," commented Dr. Keith Flaherty, Associate Professor of Medicine, Abramson Cancer Center of the University of Pennsylvania Health System and a principal investigator for this trial. "MGCD0103 has shown significant activity in preclinical models, as well as objective responses in ongoing clinical trials. This clinical study will help build an understanding of the role of HDAC inhibitors in the treatment of solid tumors for which docetaxel remains an important standard treatment, an area of great interest to the research and clinical community."

About MGCD0103

MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor. Preclinical data suggest that the Class I HDAC isotypes targeted by MGCD0103 are important in cancer biology and, consequently, such selective HDAC inhibitors may have increased efficacy and reduced toxicity compared to non-selective inhibitors. MGCD0103 is being investigated as a single agent and in combination with other anticancer therapies in the treatment of a variety of hematological malignancies and solid tumors. MGCD0103 is currently being studied in clinical trials including Hodgkin's lymphoma, non-Hodgkin's lymphoma (NHL), myelodysplastic syndromes (MDS), acute myelogenous leukemia (AML), and pancreatic cancer as either a single agent or in combination with anticancer therapies.

MGCD0103 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and has been designated an orphan medicinal product by the European Medicines Agency (EMEA) for the treatment of Hodgkin's lymphoma.

About MethylGene

MethylGene Inc. (TSX:MYG) is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's lead product, MGCD0103, is an oral isotype-selective HDAC inhibitor presently in multiple clinical trials for solid tumors and hematological malignancies, including Phase II monotherapy and Phase I/II combination trials with Vidaza®, Gemzar® and Taxotere®. MGCD265 is an oral kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene has several preclinical programs: MGCD290 an HDAC inhibitor in combination with azoles for fungal infections; an HDAC program for Huntington's disease; a sirtuins program for cancer; and a beta-lactamase program to overcome antibiotic resistance. MethylGene's development and commercialization partners include Pharmion Corporation, Taiho Pharmaceutical and EnVivo Pharmaceuticals. Please visit our website at www.methylgene.com.

About Pharmion

Pharmion is a leading global oncology company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world's first approved epigenetic drug, Vidaza®, a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at www.pharmion.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 ability to demonstrate pharmacokinetic / bioequivalency; the timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD0103, MGCD265 or MGCD290; the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD0103, MGCD265 or MGCD290, 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 or MGCD290.
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, 2006, under the heading 'risk factors,' the final prospectus filed on February 23, 2007, and all other documents filed by the Company 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.

Contact Information

  • Rx Communications Group, LLC
    Rhonda Chiger
    917-322-2569
    rchiger@rxir.com
    or
    MethylGene Inc.
    Donald F. Corcoran
    President & CEO
    514-337-3333 ext. 373
    mctavishk@methylgene.con
    or
    Pharmion Corporation
    Breanna Burkart
    Director, Investor Relations and Corporate Communications
    720-564-9144
    bburkart@pharmion.com
    or
    Pharmion Corporation
    Anna Sussman
    Director, Investor Relations and Corporate Communications
    720-564-9143
    asussman@pharmion.com