� MethylGene Inc. (TSX:MYG) announced that as a result of the home voluntary suspension of enrolment of modern patients into clinical trials evaluating MGCD0103, MethylGene and its development partner, Celgene Corporation, have been informed by the U.S. Food and Drug Administration (FDA) that the agency concurs with the action and is concomitantly placing a partial clinical hold on new patient enrollment for MGCD0103 clinical trials as it awaits the companies' submission of data and action plan to mitigate risk for patients.
A partial clinical hold is a check or hanging of only part of the clinical work requested under the investigational modern drug (IND) application (e.g., a specific protocol or region of a protocol is not allowed to continue; however, other protocols or parts of the protocol are allowed to go under the IND). Under the partial clinical contain, patients currently enrolled in MGCD0103 clinical trials wHO are confirmed to hold no signs or symptoms of pericarditis or pericardial effusion may continue in their several studies.
The companies had already begun to establish an action plan and data analysis package to submit to the FDA. The action plan with risk extenuation steps volition be communicated to regulative agencies and clinical investigators. Some of the stairs are expected to include specific steering for identifying patients at potential danger as good as management of patients who may develop pericarditis / pericardial effusion patch undergoing treatment with MGCD0103. MethylGene and Celgene ar working closely together with the FDA to complete this bundle and communicate it with the FDA to hold approval to commence registration of new patients as soon as possible.
About MGCD0103
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� for solid tumors; two Phase I/II trials, the first in combination with Vidaza� for hematological malignances and the moment with Gemzar� for pancreatic cancer; several Phase II monotherapy trials in haematological malignancies and, more lately, a Phase II, three-arm combination test 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 handling of Hodgkin lymphoma and AML.
About MethylGene
MethylGene Inc. (TSX: MYG) is a publicly-traded, clinical stage, biopharmaceutical company focused on the discovery, development and commercialisation 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�, Gemzar� and Taxotere�. MGCD265 is an unwritten, multi-targeted kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases and is in Phase I clinical trials for firm tumor cancers. In add-on, MethylGene's preclinical programs let in: MGCD290, an HDAC inhibitor used in combination with azoles for fungal infections, a kinase inhibitor program for optic diseases, and a sirtuin inhibitor plan for malignant neoplastic disease. 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 http://www.methylgene.com.
About Celgene
Celgene Corporation, based in Summit, New Jersey, is an integrated globose biopharmaceutical company engaged chiefly in the discovery, developing and commercialization of novel therapies for the discourse of cancer and rabble-rousing diseases through gene and protein rule. For more information, please visit the Company's web site at http://www.celgene.com.
Certain statements contained in this news waiver, other than statements of fact that are severally verifiable at the date hereof, may constitute innovative statements. Such statements, based as they are on the stream expectations of management of MethylGene, inherently involve legion risks and uncertainties, known and nameless, many of which ar 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 ar 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 winner, efficacy or safety of MGCD0103, MGCD265 or MGCD290; the ability to scale up, word and manufacture sufficient GMP, clinical or commercialization quantities of MGCD0103, MGCD265 or MGCD290, and the congener success or the lack of success in developing and gaining regulatory blessing and/or market place acceptance for any combine or new product including MGCD0103, MGCD265 or MGCD290. Such risks include, merely are not limited to, the impact of general economic conditions, economic conditions in the pharmaceutical industry, changes in the regulative 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
