Print

FDA has granted Fast Track Status to Active Biotech's TTS cancer project

2004-12-01

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)
Sven Andréasson
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

pdf



Back