Novacea, Inc. reported that it has received notice from the United States Food and Drug Administration (FDA) that the agency has released the clinical hold on the Asentar(TM) Investigational New Drug (IND) application.
The US FDA's response was based on the completion of their review of information submitted by Novacea to address issues relating to the clinical hold raised by the regulatory agency in November 2007. Novacea had terminated the ASCENT-2 Phase 3 clinical trial in November 2007 due to an unexplained imbalance of deaths between the treatment and control arms of the trial.
As part of their guidance, the FDA requires that any future clinical studies conducted with Asentar must include in the consent form an unambiguous statement that the ASCENT-2 trial showed reduced survival for patients with androgen-independent prostate cancer (AIPC) given Asentar in combination with weekly Taxotere(R) (docetaxel) chemotherapy, as compared to AIPC patients receiving Taxotere administered every three weeks without Asentar. Also, any future consent form must not make reference to any survival benefits observed in earlier clinical trials involving Asentar for the treatment of AIPC patients. As previously announced, Novacea has no clinical trials planned for Asentar.
"We are pleased that the FDA released the clinical hold on Asentar following their review," said Edward F. Schnipper, M.D., Novacea's executive vice president and chief medical officer.
John P. Walker, Novacea's chief executive officer and chairman of the board, commented, "We welcome the FDA's response regarding their release of the clinical hold on Asentar. Following the exciting news last week regarding our proposed merger with Transcept Pharmaceuticals, and the related new direction for Novacea, we have no plans for further development of Asentar."