Telik, Inc. (Nasdaq: TELK) announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug (IND) application for TELCYTA® (canfosfamide HCl).
The clinical hold was initiated by FDA following the presentation of TELCYTA Phase 3 clinical trial results at the annual meeting of the American Society of Clinical Oncology.
No new patients will be enrolled on TELCYTA clinical trials, and no patients currently being treated on the trials will receive additional treatment until the FDA releases the clinical hold. Telik plans to submit to the FDA additional detailed safety and other information regarding TELCYTA and meet with the FDA regarding the clinical hold as soon as possible.
The only TELCYTA clinical trial that had been open for new patient enrollment was the ASSIST-5 trial of TELCYTA plus pegylated liposomal doxorubicin (PLD) versus PLD alone in second line therapy of platinum refractory or resistant ovarian cancer. In addition, a small number of patients had continued to receive TELCYTA treatment in previously-enrolled clinical trials. -Telik, Inc.
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