On March 13, 2006, all six volunteers who received a test biologic in a clinical pharmacology (Phase I) study conducted for biopharmaceutical company TeGenero AG, W?rzburg, Germany experienced an unexpected adverse reaction. This is the first time the drug had been introduced into humans. The biologic, TGN 1412 is an immunomodulatory humanized agonistic anti-CD28 monoclonal antibody being developed by sponsor TeGenero AG for the treatment of autoimmune/inflammatory diseases and hemato-oncological malignancies.

TeGenero contracted with PAREXEL International to study the new substance in PAREXEL's Clinical Pharmacology Unit located in Northwick Park Hospital in London, England. Phase I clinical trials are conducted according to strict ethical and regulatory requirements and involve a small group of healthy volunteers in whom a substance is introduced for the first time with the goal of evaluating tolerability.

"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 " , commented Dr. Benedikte Hatz, Chief Executive Officer of TeGenero AG. "The clinical trial performed by PAREXEL adhered to standard clinical research guidelines."

"When the adverse reaction occurred, the PAREXEL clinical pharmacology medical team responded swiftly to stop the study procedures immediately and notified authorities. We worked in cooperation with the hospital intensive care doctors and the sponsor to have the volunteers given the best possible care, and to explore all possible treatment options," said Professor Herman Scholtz, MD, Head of PAREXEL International Clinical Pharmacology.

"Such an adverse reaction occurs extremely rarely and this is an unfortunate and unusual situation. We have a high quality medical team in our Northwick Park unit. Since our unit is located within the hospital, we had immediate access to the intensive care unit of the hospital, and we did everything possible to get the volunteers treated as quickly as possible," said Dr. Scholtz.

The patients are now in the care of Northwick Park Hospital.

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