6 hospitalised in PI debacle:
Message 22260555
Statement re Clinical Volunteers and TGN 1412
March 15, 2006
Volunteers taking part in a clinical trial involving TeGenero’s study drug monoclonal antibody TGN1412 have experienced adverse events. The study, sponsored by TeGenero, involves TeGenero’s TGN1412, an immunomodulatory humanized agonistic anti-CD28 monoclonal antibody that is being developed for the treatment of immunological diseases with a high unmet medical need, such as multiple sclerosis, rheumatoid arthritis and certain cancers.
“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, TeGenero AG. The clinical trial performed by the contract research organization, PAREXEL International, adhered to standard clinical research guidelines.”
The clinical trial was approved by the Medicines and Healthcare products Regulatory Agency, the UK regulatory authority responsible for clinical trial approval, and the local Ethics Committee.
“The drug was developed in accordance with all regulatory and clinical guidelines and standards. In pre-clinical studies, TGN1412 has been shown to be safe and the reactions which occurred in these volunteers were completely unexpected,” said Dr. Thomas Hanke, Chief Scientific Officer of TeGenero AG.
About TeGenero AG
TeGenero AG is a privately held biopharmaceutical company dedicated to the development of innovative, highly effective and broadly applicable therapeutic drugs for the treatment of severe immunological disorders. The company was founded in 2000 and is located in Würzburg, Germany. |
