By ROBERT BARR Associated Press Writer
© 2006 The Associated Press

LONDON — Two men were hospitalized in critical condition Wednesday and four others were in serious condition after suffering adverse reactions in trials of a new drug, and British regulators ordered the tests suspended.

Parexel International, which supervised the trial, identified the drug as TGN1412, a monoclonal antibody developed by TeGenero AG of Wuerzburg, Germany, for treatment of autoimmune and inflammatory diseases and leukemia.

Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, said two of the men were in critical condition and four were in serious condition but showing signs of improvement.

“The drug, which is untested and therefore unused by doctors, has caused an inflammatory response which affects some organs of the body,” Suntharalingam said.

The names of the six were not released.

“These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies, which enabled us to progress investigations into human volunteers,” TeGenero’s chief executive Dr. Benedikte Hatz said.

The clinical trial was performed by the research organization, Parexel International, based in Waltham, Mass., which “adhered to standard clinical research guidelines,” said Dr. Thomas Hanke, the company’s chief scientific officer.

Parexel International has a clinical pharmacology research unit at the hospital.

“Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation,” said Dr. Herman Scholtz, head of Parexel International Clinical Pharmacology.

The Medicines and Healthcare Products Regulatory Agency, which ordered the tests suspended, said the six were the only people given the drug in a small trial. Two other subjects received placebos.

“Our immediate priority has been to ensure that no further patients are harmed,” said Kent Woods, the agency’s chief executive officer. “We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken.”

Source: Chron.com | Six Hospitalized in British Drug Trial
About TGN1412

TGN1412 is a Humanized Agonistic Anti-CD28 Monoclonal Antibody that is being developed by TeGenero AG for the treatment of autoimmune and oncological diseases including rheumatoid arthritis and B-cell Chronic Lymphocytic Leukaemia, B-CLL.

The drug, also known as anti-CD28 SuperMAB, received EU-orphan drug designation for the treatment of B-CLL - March 10, 2005. As reported on Medscape, “The approval was based on the results of preclinical studies demonstrating the product’s potential to reduce infection and improve control of cancer. . . . In B-CLL, the total leukemic cell burden tends to expand at variable speed (although the clinical course may be stable for years) without any apparent action of the immune system against the tumor…. Although its mechanism of action remains unclear, TGN1412 is thought to enhance T-lymphocyte activation, thereby inducing CLL B-cells to become effective APCs for tumor-antigen specific T cells. The product has also demonstrated the potential to increase susceptibility of CLL tumor cells to induction of apoptosis.”