FDA has granted Fast Track Status to Active Biotech's TTS cancer project
FDA's fast track program is designed to facilitate the development of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address important unmet medical needs.
Currently, a Phase I clinical study with TTS CD3 is under way and the Phase II/III clinical program is planned to start during 2005. This time plan is dependent of the length of the ongoing dose-escalation study, i.e. when a maximal dose is obtained.
In parallel with the ongoing Phase I studies, Active Biotech intends to start a clinical study to examine the safety of TTS CD3 in combination with established chemotherapies of non- small cell lung cancer.
Lund, December 1, 2004
Active Biotech AB (publ)
President & CEO
Active Biotech AB is a biotechnology company focusing on research in and development of pharmaceuticals. Active Biotech has a strong R&D portfolio and pipeline products with focus primarily on autoimmune/inflammatory diseases and cancer. Most advanced projects include orally administered small molecules with unique immunomodulatory properties that can be used to treat autoimmune and inflammatory diseases, as well as a novel concept for use in cancer immunotherapy.
Active Biotech AB
Box 724, SE-220 07 Lund, Sweden
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 20 50