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METHYLGENE REPORTS CLINICAL DATA FROM A PHASE II STUDY EVALUATING MGCD0103 IN RELAPSED OR REFRACTORY NON-HODGKIN LYMPHOMAS AT THE 44TH AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO) ANNUAL MEETING
Chicago, Illinois. June 3, 2008 – MethylGene Inc. (TSX:MYG) today announced preliminary data from a Phase II clinical study evaluating MGCD0103, a novel, isoform-selective histone deacetylase (HDAC) inhibitor, in relapsed or refractory non-Hodgkin lymphomas (Trial 008). Results from this single-agent trial, conducted in collaboration with Celgene Corporation and Taiho Pharmaceutical, were presented today at the 44th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Treatment of Relapsed or Refractory Lymphoma with the Oral Isotype-Selective Histone Deacetylase Inhibitor MGCD0103: Interim Results From a Phase II Study, Abstract #8528 (Trial 008)
To date, 69 patients have been treated in this Phase II study evaluating MGCD0103 as a single-agent in non-Hodgkin lymphomas (NHL) and 59 patients were evaluable for efficacy. Specific patient populations in this study included pretreated patients with diffuse large B-cell lymphoma (DLBCL) (n=41 enrolled) and follicular lymphoma (FL) (n=28 enrolled). All patients have had prior treatments, with four being the median number of prior treatments (excluding radiation, surgery and transplant). Ninety-five percent of the patients were previously treated with Rituxan(R). In this study, patients were initially administered a starting dose of 110mg of MGCD0103 (n=32) with more recently enrolled patients receiving a starting dose of 85mg (n=37). MGCD0103 was administered three times per week for four weeks (one cycle).
In the DLBCL cohort, the objective response rate was 15 percent [one complete response (CR) and five partial responses (PRs)] for enrolled patients and of the evaluable patients in this cohort, 60 percent experienced tumor reduction as assessed by CT scan. The objective response rate for enrolled patients in the FL cohort was seven percent (2 PRs) and 54 percent of the evaluable FL patients experienced tumor reduction as assessed by CT scan. The median duration on study for responders in the DLBCL population is greater than five cycles and in the FL population it is greater than 11 cycles.
All 69 patients enrolled were evaluable for safety. At the time of analysis, the most common drug-related toxicities of Grade 3 or greater were fatigue (22 percent), thrombocytopenia (13 percent), neutropenia (12 percent) and anemia (7 percent). Fifteen patients (22 percent) discontinued the trial due to adverse events. Analysis of the 85mg dose cohort demonstrated fewer Grade 3 and Grade 4 toxicities and lower overall hematological toxicities, as well as fewer discontinuations due to adverse events than the 110mg dose.
Future MGCD0103 trials in the pretreated relapsed or refractory DLBCL patient population could include a combination of MGCD0103 with Rituxan(R) or with other agents. Patient enrollment is now closed in both indications.
About MGCD0103
MGCD0103 is an orally-administered, isoform-selective HDAC inhibitor. The compound is currently in one Phase I combination clinical trial with Taxotere(R) for solid tumors, two Phase I/II combination trials with Vidaza(R) for hematological malignancies and with Gemzar(R) for pancreatic cancer, and five Phase II clinical trials in hematological malignancies. 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 EMEA for the treatment of Hodgkin lymphoma and acute myelogenous leukemia.
About MethylGene
MethylGene Inc. (TSX: MYG) is a publicly-traded, clinical stage, biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's lead product, MGCD0103, is an oral, isoform-selective HDAC inhibitor presently in multiple clinical trials for solid tumors and hematological malignancies, including Phase II monotherapy and Phase I, Phase I/II and Phase II combination trials with Vidaza(R), Gemzar(R) and Taxotere(R). MGCD265 is an oral, multi-targeted kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases and is in Phase I clinical trials for solid tumor cancers. In addition, MethylGene’s preclinical programs include: MGCD290, an HDAC inhibitor used in combination with azoles for fungal infections, a kinase inhibitor program for ocular diseases, and a sirtuin inhibitor program for cancer. MethylGene's development and commercialization partners include Celgene Corporation, Taiho Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd. and EnVivo Pharmaceuticals. 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 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, 2007, under the heading ‘risk factors,’, 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:
Donald F. Corcoran
President & CEO
MethylGene Inc.
Phone: 514-337-3333 ext. 373
mctavishk@methylgene.com
Rhonda Chiger
Rx Communications Group, LLC
Phone: 917-322-2569
rchiger@rxir.com
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