FDA Converts TELCYTA Full Clinical Hold To Partial Hold
U.S. Food and Drug Administration has converted the recently announced full clinical hold of TELCYTA trials to a partial hold.
This action will enable patients currently enrolled in the ASSIST-3 and ASSIST-5 trials the opportunity to continue to receive study treatments, including TELCYTA in combination with chemotherapy, subject to re-consenting procedures. Telik continues to work closely with the FDA in its review of TELCYTA.
Telik, Inc. of Palo Alto, CA is a biopharmaceutical company focused on discovering, developing and commercializing novel small molecule drugs to treat serious diseases. The company's most advanced drug development candidate is TELCYTA, a tumor-activated small molecule product candidate in clinical development for the treatment of advanced ovarian cancer and non-small cell lung cancer.
A second drug development candidate, TELINTRA (TLK199), is in clinical development for myelodysplastic syndrome. Telik's product candidates were discovered using its proprietary drug discovery technology, TRAP, which enables the rapid and efficient discovery of small molecule drug candidates.