MONTREAL, QUEBEC--(Marketwire - June 07, 2010) - MethylGene Inc. (TSX: MYG) today disclosed preliminary clinical data for mocetinostat in a poster presentation at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting held in Chicago, IL. Mocetinostat is an oral, isotype-selective histone deacetylase inhibitor which is currently in a Phase II clinical trial (Trial 008) in patients with relapsed or refractory follicular lymphoma.
Phase II Study of Mocetinostat (MGCD0103) in Patients with Relapsed Follicular Lymphoma: Study Re-initiation and Update of Clinical Efficacy and Safety (Trial 0103-008), Abstract #8086
Trial 008 is a Phase II single-agent study of oral mocetinostat administered three times per week with starting doses of 85mg or 110mg for 28 days (one cycle) in refractory or relapsed follicular lymphoma patients. Twenty-eight patients were initially administered mocetinostat at these starting doses. Eighty-two percent of these patients had received three or more prior therapies. The updated efficacy evaluation demonstrated that one patient experienced complete response and two additional patients experienced partial responses, for an overall objective response rate of 11 percent. In addition, 20 patients were evaluated by CT scan of which 13 (65%) experienced tumor shrinkage. The most common toxicities greater than or equal to grade 3 included fatigue, anemia, nausea, anorexia, hyponatremia, neutropenia and thrombocytopenia.
The patient experiencing a complete response (ongoing as of April 1, 2010 for a response time of over two years) has not had any subsequent anticancer therapy. This patient became a complete responder on cycle 6 and was initially dosed at 85mg which was reduced to 60mg after approximately 4.5 cycles. This patient received mocetinostat therapy for 15 months.
Additional Safety Data
This trial and other mocetinostat trials were voluntarily suspended for new patient enrollment in July 2008 until further investigation due to incidences of pericardial serious adverse events (SAE). Of the 437 patients treated on all mocetinostat clinical trials, 19 patients (4.3%) experienced a pericardial SAE. A subset of patients (n equal 115) were solid tumor patients for which there was only one pericardial SAE (0.9% incidence rate). There was one pericardial SAE out of 33 treated relapsed or refractory follicular lymphoma patients (3% incidence rate). Most of the pericardial SAEs (14 of 19) occurred during the first cycle of treatment with statistically significant association found only in patients who had a history of pericardial disease, presence of lung lesions and on-study reports of chest pain or pleural effusion. Patients with pericardial SAEs were effectively managed medically and/or surgically with complete resolution in most patients. There were no deaths due to pericardial SAEs. While a role of mocetinostat in pericardial events cannot be ruled out, numerous confounding factors, including the disease itself, make the interpretation difficult.
Recently, in concurrence with the U.S. Food and Drug Administration (FDA), the Company re-initiated Trial 008 in refractory and relapsed follicular lymphoma patients who have had three or more therapies. The Company plans to enroll up to 13 new patients and patient dosing has commenced. New patients enrolled in this trial will be given oral mocetinostat three times per week at a starting dose of 70mg with the primary endpoint being overall response rate.
“As we continue to collect and review data from this Phase II trial as well as from our other trials, we are reminded of mocetinostat’s activity in a number of patient populations who had failed prior therapies.” said Donald F. Corcoran, President and Chief Executive Officer of MethylGene. “We look forward to continuing to enroll patients into Trial 008 and gather additional insight into the drug’s activity and profile with the goal of seeking a partner for further development.”
About MethylGene
MethylGene Inc. (TSX: MYG) is a publicly-traded, clinical stage biopharmaceutical company focused on the discovery, 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 serious fungal infections which has completed Phase I clinical studies; and mocetinostat (MGCD0103), an oral, isoform-selective HDAC inhibitor for cancer which has been in multiple Phase II clinical trials and is currently in a Phase II 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, is in Phase I 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.
Contacts:
Rhonda Chiger
Rx Communications Group, LLC
917-322-2569
rchiger@rxir.com
MethylGene Inc.
Donald F. Corcoran
President & CEO
514-337-3333 ext. 373
mctavishk@methylgene.com