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Statement re Clinical Volunteers and TGN 1412 |
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16 Mar 2006 |
Thomas Hanke, TeGenero's CSO speaks about TGN1412
WÜRZBURG, Germany | Mar 15, 2006 |Thomas Hanke, Chief Scientific Officer of TeGenero;
“Our first concern right now is for the patients and families and that they get all treatment possible. We are confident in the excellent treatment at this hospital and have made ourselves available to answer any questions from the doctors about the drug.
The drug being tested, TGN1412, is an innovative new treatment for the devastating illnesses of leukaemia, rheumatoid arthritis and multiple sclerosis.
The investigation must proceed as quickly as possible into these shocking developments in the testing of a new medicine which showed no signs of any safety problems in previous testing.
Our thoughts are with the patients and the families.”
Notes:
Parexel was conducting the first human testing of TGN1412 for TeGenero AG. The trial was approved by the MHRA and the local ethics committee.
There is no further human testing of TGN1412 being pursued.
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.
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.
Contact:
TeGenero AG
K. Kaufmann
Science Park Würzburg
Friedrich-Bergius-Ring 15
D-97076 Würzburg
Phone: +49 (0) 931-35 96 2-0
Fax: +49 (0) 931-35 96 2-11
Email:
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SOURCE: TeGenero AG |
