BOULDER, Colo. and MONTREAL, Oct. 10 /PRNewswire-FirstCall/ -- Pharmion Corporation and MethylGene Inc. today announced the initiation of a Phase One clinical trial evaluating MGCD0103, the Companies’ isotype-selective histone deacetylase inhibitor (HDACi) product candidate, in combination with Taxotere(R) (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 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(R), a DNA demethylating agent. For additional information about Pharmion, please visit the company’s website at www.pharmion.com.
About MethylGene
MethylGene Inc. 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(R), Gemzar(R) and Taxotere(R). 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.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements relating to the planned development program for MGCD0103, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Pharmion’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include, but are not limited to, the potential failure of MGCD0103, to demonstrate safety and efficacy in clinical and non-clinical testing; the ability to complete regulatory submissions and gain regulatory approvals in a timely manner; the ability to initiate and complete trials at the referenced times; the impact of competition from other products under development by Pharmion’s competitors; the uncertainty of the regulatory environment and changes in the health policies of various countries; acceptance and demand for new pharmaceutical products and new therapies; uncertainties regarding market acceptance of products newly launched, currently being sold or in development; failure of third-party manufacturers to produce the product volumes required on a timely basis and fluctuations in currency exchange rates. Additional risks and uncertainties relating to Pharmion and its business can be found in the “Risk Factors” section of Pharmion’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2007, its Annual Report on Form 10-K for the year ended December 31, 2006 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and Pharmion undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
CONTACT: Breanna Burkart, Director, Investor Relations and Corporate
Communications, +1-720-564-9144, bburkart@pharmion.com, or Anna Sussman,
Director, Investor Relations and Corporate Communications, +1-720-564-9143,
asussman@pharmion.com, both of Pharmion Corporation; Rhonda Chiger of Rx
Communications Group, LLC, +1-917-322-2569, rchiger@rxir.com, for
MethylGene Inc.; or Donald F. Corcoran, President & CEO of MethylGene Inc.,
+1-514-337- 3333 ext. 373
Web site: http://www.pharmion.com/
http://www.methylgene.com//
