The Immune Response Corp. said Monday that the FDA gave its firstapproval of its unnamed HIV immunotherapeutic productmanufactured at a new facility.
The approval relates only to product for patients previously enrolledin Phase I and II studies, who will continue using theimmunotherapeutic in an open-label extension study. The companystill needs to obtain process validations from the FDA beforebeginning a larger Phase III study in HIV patients.
Steve Basta, executive director of product development for theCarlsbad, Calif., company said a modified process is being used forthe Phase III trial, which will allow a more efficient scale-up. "Weare certainly on track to start the Phase III studies this year," he said.
The proposed Phase III trial is being designed to include as many as5,000 patients, who will be separated into one of three armsdepending on CD4 counts. (See BioWorld Today, Jan. 30, 1995, andMarch 6, 1995, p. 1.)
Immune Response got all rights to the vaccine when Rhone-PoulencRorer Inc., of Collegeville, Pa., relinquished its stake in a jointventure for the product. The companies had been working togethersince 1988.
Basta said the company is "clearly focused on getting back into theclinic, starting the Phase III trials and accelerating the developmentof the HIV therapy.
Immune Response's stock was up $1.44 Monday, or 46 percent, toclose at $4.56 per share. That's the same closing price it had on Jan.30, when an FDA advisory committee recommended that the PhaseIII trial be allowed. _ Jim Shrine
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