Canada's MethylGene says that as a result of its voluntary decision to halt enrollment in a new drug study, the FDA has put a partial clinical hold on its lead development program in cancer. The agency says it is waiting to see data and a risk mitigation plan to protect volunteers in the study. MGCD0103 is partnered with Celgene as a therapy for solid tumors and hematological malignancies.
"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 enrollment of new patients as soon as possible."
- read the press release [1]
- check out the report [2] on the Canadian Press
Related Articles:
MethylGene, Celgene Announce Precautionary Suspension of Enrollments [3]
Links:
[1] http://www.medicalnewstoday.com/articles/118547.php
[2] http://canadianpress.google.com/article/ALeqM5gSLxpPLS_gYAAxlWSgvhcM7CO1XA
[3] http://www.fiercebiotech.com/press-releases/methylgene-and-celgene-announce-precautionary-suspension-new-enrollments-mgcd0103-cli