Savient Terminates Phase II Trial for Prosaptide

Savient Pharmaceuticals plans to terminate its dose-ranging Phase II trial of Prosaptide.

This trial was designed to test the safety and analgesic efficacy of Prosaptide in HIV/AIDS patients with peripheral neuropathic pain. A formal interim analysis was scheduled, pursuant to the trial protocol, to perform a statistical test on early data to predict the probability of success at the analgesia efficacy endpoint if the trial were carried through to completion.

The trial will be terminated following the recommendation of the data and safety monitoring board (DSMB), which recently met to discuss the results of the scheduled interim analysis of unblinded study data conducted by the Center of Biostatistics AIDS Research (CBAR) at the Harvard School of Public Health. At that time, the DSMB requested further information from CBAR to clarify the results.

On March 10, the DSMB recommended that Savient terminate the trial on the basis of the interim analysis, which indicated that even if the trial were to continue to its planned end there would be little chance of attaining statistical significance at the analgesia efficacy endpoint.