Savient Pharmaceuticals, Inc., an emerging specialty pharmaceuticals company, has decided to terminate its dose ranging Phase 2 trial of Prosaptide. This trial was designed to test the safety and analgesic efficacy of Prosaptide in HIV/AIDS patients with peripheral neuropathic pain.
According to the release, the trial will be terminated following the recommendation of the Data and Safety Monitoring Board (DSMB) which held a meeting in Boston on February 22, 2005 to discuss the results of the scheduled interim analysis of un-blinded study data conducted by the Centre 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.
Dr. Zeb Horowitz, chief medical officer of Savient Pharmaceuticals said, "The termination of the Prosaptide Phase 2 study for lack of analgesic efficacy is clearly a disappointment. This interim analysis, which we designed into the protocol, allows us to conclude the trial early and look ahead to the next critical decisions. We now need some time to understand the basis for this outcome and to determine the next potential steps. There is also much we still do not know about the potential for Prosaptide in the treatment of peripheral neuropathy as this study was not designed for that purpose."
On March 10, 2005, the DSMB provided Savient, in writing, a recommendation to 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.