Remune: Phase II data; Phase III

IMNR said that a new review by an independent Data Safety Monitoring Board (DSMB) of the company's Spanish Phase II trial showed that Remune had met its primary endpoint of time to virologic failure stratified on baseline viral load (p=0.034). IMNR said an earlier review by the DSMB, which concluded the study did not meet the primary endpoint, was insufficient since it did not include the complete follow-up time of all patients and the intent-to-treat analysis (see BioCentury, June 4).

Separately, IMNR said it will not continue a Phase III study of Remune started by former partner Agouron Pharmaceuticals Inc. Agouron, a subsidiary of Pfizer Inc. (PFE, New York, N.Y.), terminated its development and marketing agreement for IMNR's Remune in July (see BioCentury, July 9). IMNR said few of the patients in either arm of the trial had failed therapy. As a result, the company said the trial was unlikely to achieve its primary endpoint of showing that the addition of Remune to PFE's Viracept and Combivir from GlaxoSmithKline plc (LSE:GSK; GSK, London, U.K.) delays time to virologic failure. The trial, which was expected to enroll 555 patients, had enrolled 376 patients to date. ...