Drug test subjects fall seriously ill
Six hospitalized after a trial run by Waltham firm
Six volunteers taking part in a clinical drug trial run by Parexel International Corp. have been admitted to a London hospital where they are in ''a serious condition."
The six male patients are being treated in the critical care unit at Northwick Park Hospital, North West London Hospitals NHS Trust said in an e-mailed statement.
The patients were admitted yesterday ''from an independent medical research unit on the Northwick Park hospital campus operated by Parexel," the statement said. ''The patients we are treating were volunteers in a drug trial being run by Parexel."
The volunteers suffered an ''adverse drug reaction," Waltham-based Parexel said in an e-mailed statement. The company said they have been involved in tests of TGN 1412, an ''immunomodulatory humanized agonistic anti-CD28 monoclonal antibody" being developed by Germany's TeGenero AG.
The six volunteers, all thought to be Australian, were taking part in first-stage trials of an anti-inflammatory drug for treatment of conditions including rheumatoid arthritis and leukemia, the British Broadcasting Corp. said.
The men are ''in a serious condition and they are all receiving close monitoring and appropriate treatment," Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital said in an e-mailed statement.
Some of the men have suffered multiple organ failure and are in life-threatening conditions, the BBC said, citing unidentified hospital sources.
The United Kingdom's Medicines and Healthcare products Regulatory Agency, which has begun an investigation into the incident, has suspended all trials of the drug.
''Eight men took part in this stage of the clinical trial; six were given the product and two were given a placebo," the agency said in a statement on its website.
Shares of Parexel declined 52 cents, or 2 percent, to $26.19.
