MONTREAL - Cancer drug developer MethylGene Inc. (TSX:MYG) says the U.S. Food and Drug Administration is placing a "partial clinical hold" on new patient enrolment for the clinical trial of its lead product for solid tumours and hematological malignancies.
The Montreal-based company said the hold is happening as the FDA awaits the companies' submission of data and action plan to mitigate risk for patients.
MethylGene said it volunteered to stop enrolling new patients in the clinical trials for MGCD0103, which it is developing with partner, Celgene Corp.
A partial clinical hold is a delay or suspension of part of the clinical work requested under the investigational new drug application.
However, the company said other protocols or parts of the protocol are allowed to proceed.
"Under the partial clinical hold, patients currently enrolled in MGCD0103 clinical trials who are confirmed to have no signs or symptoms of pericarditis or pericardial effusion may continue in their respective studies," the company stated in a release
"MethylGene and Celgene are working closely together with the FDA to complete this package and communicate it with the FDA to obtain approval to commence enrolment of new patients as soon as possible."
MethylGene shares were unchanged at 97 cents on the TSX Friday.
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