|By Marketwired .||
|December 6, 2010 07:30 AM EST||
MONTREAL, QUEBEC -- (Marketwire) -- 12/06/10 -- MethylGene Inc. (TSX: MYG) disclosed final clinical data of its Phase 2 trial of mocetinostat in relapsed/refractory Hodgkin lymphoma (Trial 0103-010) in a poster presentation at the 52nd American Society of Hematology (ASH) Annual Meeting held in Orlando, FL. Mocetinostat is MethylGene's proprietary oral, isotype-selective histone deacetylase inhibitor.
Mocetinostat (MGCD0103), an Isotype-Selective Histone Deacetylase (HDAC) Inhibitor, Produces Clinical Reponses in Relapsed / Refractory Hodgkin Lymphoma: Update from a Phase 2 Clinical Study (Trial 0103-010), Poster No. I-743.
Trial 0103-010 is a Phase 2 single-agent study of oral mocetinostat administered three times per week with starting doses of 85 mg or 110 mg for 28-day cycles in refractory or relapsed Hodgkin lymphoma patients. A total of 51 patients were enrolled in this trial (23 patients in the 110 mg cohort and 28 patients in the 85 mg cohort). These patients represent a heavily pretreated population with a median of five prior lines of chemotherapy. Additionally, 84 percent of the patients had previously received one or more bone marrow or stem cell transplants.
Data in the efficacy evaluable population (n=43 patients) demonstrated that two patients experienced complete responses, 12 patients experienced partial responses, and one patient experienced durable stable disease for at least six months. The treatment success rate, as defined by the protocol as complete responses + partial responses + stable disease greater than or equal to six months, was 35 percent in the efficacy evaluable population (n=43) and 29 percent in the intent-to-treat population (n=51). In addition, for patients with measurable lesions for which tumor dimensions were determined by CT scan, 81 percent (34 of 42 patients) showed reduction in tumor size. The most common toxicities greater than or equal to grade 3 in at least five percent of patients included fatigue, neutropenia, pneumonia, thrombocytopenia, anemia, pericardial effusion and abnormal liver function test. Trial 0103-010 is closed and the final data are being prepared for publication.
"Mocetinostat has demonstrated single-agent activity in these heavily pretreated patients," commented Dr. Anas Younes, Professor and Director of the Clinical and Translational Research Program for the Department of Lymphomas/Myeloma, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center. "The response rate reported in this study is amongst the best single agent activity described in Hodgkin lymphoma with HDAC inhibitors, especially in the context of the minimal hematological toxicity observed. Further development of mocetinostat in Hodgkin lymphoma is warranted, particularly in less heavily pretreated patients."
Mocetinostat (MGCD0103) is an orally-administered, isoform-selective HDAC inhibitor. The compound is currently in a Phase 2 clinical trial in relapsed/refractory follicular lymphoma (Trial 0103-008) and has been tested in multiple Phase 1 and Phase 2 clinical trials both as a single-agent and in combination with Vidaza® and Gemzar®. Mocetinostat 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 lymphoma and acute myeloid leukemia.
MethylGene Inc. (TSX: MYG) is a publicly-traded, clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics with a focus on cancer. The Company's product candidates include: MGCD265, an oral, multi-targeted kinase inhibitor targeting the Met, VEGF, Ron and Tie-2 receptor tyrosine kinases that is in multiple clinical trials for cancer; MGCD290, a fungal Hos2 inhibitor for use in combination with fluconazole for fungal infections which has completed Phase 1 clinical studies; and mocetinostat (MGCD0103), an oral, isoform-selective HDAC inhibitor for cancer which has been tested in multiple Phase 2 clinical trials and is currently in a Phase 2 trial in refractory or relapsed follicular lymphoma. Mocetinostat is licensed to Taiho Pharmaceutical Co. Ltd in certain Asian countries. A fourth compound discovered using MethylGene's HDAC platform, EVP-0334 - a potential cognition enhancing agent for neurodegenerative diseases has successfully completed Phase 1 trials sponsored by EnVivo Pharmaceuticals Inc. MethylGene also has a funded collaboration with Otsuka Pharmaceutical Co. Ltd. for applications in ocular diseases using the Company's proprietary kinase inhibitor chemistry. Please visit our website at www.methylgene.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 timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD265, MGCD290 or mocetinostat (MGCD0103); the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD265, MGCD290 or mocetinostat, 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 MGCD265, MGCD290 or mocetinostat. 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, as described in MethylGene's Annual Information Form for the fiscal year ending December 31, 2009, under the heading "Risk Factors" which you are urged to read 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.