Six people in intensive care after clinical trial

"Drug trial axed after patients poisoned

SIX healthy volunteers have been rushed into intensive care after suddenly falling ill while participating in the trial of a new drug.
The six men, who were paid volunteers, are understood to have taken an oral preparation of the drug, being developed to treat inflammatory conditions and leukaemia, at a private research facility in Harrow, northwest London.
All of the men, who were admitted on Monday night, were suffering from multiple-organ failure at Northwick Park Hospital and two were said to be in a very serious condition. "

TeGenero’s CD28-SuperMAB® have been generated to therapeutically balance the immune system in diseases associated with life-threatening abnormalities in T lymphocyte number and function. The company’s most advanced product candidate TGN1412, a fully humanized CD28-SuperMAB®, is far advanced in pre-clinical development. It has shown exquisite and unique ex vivo and in vivo T lymphocyte activating capacity and great therapeutic potential for a number of autoimmune/inflammatory as well as oncological diseases.

Development of TGN1412 for the treatment of B-CLL
Despite clinical benefits from chemo-or monoclonal antibody therapy, B-cell chronic lymphocytic leukaemia (B-CLL) is still an incurable disease and the development of novel additional immunotherapies for the treatment of B-CLL is highly requested by hemato-oncologists. TGN1412 represents a novel class of immunomodulatory antibody and has demonstrated the potential to be effective in the treatment of B-CLL in pre-clinical trials.

The trial was set up by U.S. drug research company Parexel International Corp. on behalf of German pharmaceutical company TeGenero AG.

"Such an adverse drug reaction occurs extremely rarely," said Professor Herman Scholtz, head of Parexel International Clinical Pharmacology, in a statement.