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Fast Track Status Granted to TTS CD3 for the Treatment of Non-Small Cell Lung Cancer
LUND, Sweden, Dec. 1 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted fast track status to Active Biotech's candidate drug TTS CD3 for the treatment of non-small cell lung cancer.
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.
Source: Active Biotech AB