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Prosaptide Phase 2 Study Terminated for Lack of Analgesic Efficacy
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 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, 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.
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."
Over the next few months Savient will analyze all the available data from this study and from recently completed pre-clinical pharmacology studies. When the whole of the Prosaptide data set has been thoroughly reviewed by Savient staff and a panel of independent experts, Savient will determine whether or not the Company will pursue alternative analgesia indications, or further explore the potential of Prosaptide to treat peripheral neuropathy in HIV/AIDS and other diseases.
Source: Savient Pharmaceuticals, Inc.