MethylGene and Celgene Announce Precautionary Suspension of New Enrollments Into MGCD0103 Clinical Trials
MONTREAL, QUEBEC AND SUMMIT, NEW JERSEY, Jul 22, 2008 (MARKET WIRE via COMTEX) ----MethylGene Inc. (TSX: MYG) and Celgene Corporation today announced that, at the recommendation of a standing internal safety committee, the companies are temporarily suspending enrollment of new patients into clinical trials evaluating MGCD0103.
This voluntary precaution is being taken due to the observation of pericarditis or pericardial effusion in 19 patients out of approximately 400 patients treated to date. Approximately half of the reported cases have been deemed by investigators as unlikely to be drug related. It is not yet determined whether the potential signal is drug related due to confounding factors in these complex and late-stage cancer patients. Because the events tend to occur during the first cycle of treatment, patients currently enrolled in MGCD0103 clinical trials who have no signs or symptoms of the events are not affected by this temporary action and may continue in their respective studies.
The companies are working to fully communicate this precautionary measure to the appropriate investigators and regulatory agencies. Additionally, the companies are putting in place a series of steps moving forward to provide safe access to the clinical benefits of this promising therapy as soon as possible.
Conference Call Information
MethylGene will host a brief conference call to discuss events mentioned in this release. The call is scheduled for today, July 22nd, at 5:00 p.m. ET. MethylGene would like to invite all interested parties to participate by dialing 416-644-3419 or 1-800-595-8550 shortly before 5:00 p.m. ET. On the call from MethylGene will be:
Mr. Donald F. Corcoran, President and Chief Executive Officer
Dr. Jeffrey M. Besterman, Executive Vice President R&D and Chief Scientific Officer
Dr. Robert E. Martell, Vice President and Chief Medical Officer
A question and answer session will follow, at which time the operator will direct participants as to the correct procedure for submitting questions. A telephone replay of the conference call will also be available from July 22nd through July 28th, 2008. To access the replay, dial 416-640-1917 or 1-877-289-8525 and enter reservation number 21278982#.
MGCD0103 is an orally-administered, isoform-selective HDAC inhibitor. The compound is currently in multiple clinical trials: a Phase I trial in combination with Taxotere(R) for solid tumors; two Phase I/II trials, the first in combination with Vidaza(R) for hematological malignances and the second with Gemzar(R) for pancreatic cancer; several Phase II monotherapy trials in hematological malignancies and, more recently, a Phase II, three-arm combination trial with Vidaza 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 European Medicines Agency (EMEA) for the treatment of Hodgkin lymphoma and AML.
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.
Celgene Corporation, based in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.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.