TargeGen, Inc., a biopharmaceutical company focusing on the development of small molecule drugs for the treatment of edema and angiogenesis related diseases recently received notification from the FDA granting Fast Track Designation for TargeGen’s TG100-115 for the treatment of acute ST-elevation myocardial infarction (STEMI). TG100-115 is currently being tested in a multi-center, double blinded, placebo controlled, Phase I/II clinical trial involving approximately 70 patients. The company expects completion of this trial by the end of 2006.
“Fast Track Designation” recognizes the need to expedite the development and review of novel drugs that potentially treat life threatening conditions. Fast Track Drug Sponsors may receive various forms of assistance from the FDA which potentially facilitate more efficient new drug development and shorten approval times.
TargeGen is currently working on the development of four internally discovered drug candidates. These include TG100-115, a compound which received the UCSD Connect Most Innovative Product of the Year Award in 2004. Heart attacks are the leading disease related cause of death in the developed world. TargeGen is also working on the development of novel drugs to treat debilitating eye diseases and myeloproliferative diseases.