Warnings, Columns-Drugs & Supplements, April 2006

Adverse Events Reported in 6 of 8 TGN1412 Clinical Trial Volunteers

LONDON, England - England's Medicines and Healthcare products Regulatory Agency is reporting serious adverse events associated with TeGenero AG's and Boehringer Ingelheim's leukemia, autoimmune and inflammatory diseases TGN1412 drug.

The MHRA said on April 5 that six of the eight male volunteers who had enrolled in a recently suspended clinical trial "experienced a life-threatening incident of 'Cytokine Release Syndrome.'"

"This occurs when the substance release by activated T cells produces a type of systemic inflammatory response," the MHRA said.

According to the MHRA, Parexel, the research organization, said …