Cell Genesys Inc. said Tuesday that it has initiated a Phase I/II trial,its first in humans, for its anti-HIV T cell therapy for AIDS, the leadprogram in the company's universal receptor cell therapy program.The trial will involve 40 pairs of identical twins, in which one twin isinfected with HIV and the other is not. The study will be run by theNational Institute of Allergy and Infectious Diseases in Bethesda,Md., with Robert Walker as principal investigator.The first treatment group will involve 24 pairs of twins in a safetystudy. Then 16 pairs of twins will be added to the study to testantiviral activity, Jack Murphy, Cell Genesys' senior director,corporate communications, told BioWorld. He said the Phase IIportion of the trial would get under way in mid-1995 assuming thesafety portion is positive.In the trial, T cells will be taken from the uninfected twin,genetically modified by the introduction of anti-HIV universalreceptors, purified and then administered into the infected twin. Theuniversal receptor gene is comprised of the CD4 protein linked to asignaling protein chain. The T cells are engineered so they recognizeand destroy human cells infected with HIV. The cells will be purifiedby the Ceprate System of CellPro Inc., of Bothell, Wash.Endpoints in the Phase II part of the trial will include measurementof viral load, CD4 counts and p24 antigens. Murphy said both phasesof the open-label, dose-escalating, randomized trial, from enrollmentto analysis, are expected to take two years.The Foster City, Calif., company also said Tuesday that it was issuedU.S. patent No. 5,359,046 covering the core technology for itsuniversal receptor cell therapy program.Cell Genesys stock (NASDAQ:CEGE) closed at $7.75 per shareTuesday, down 25 cents per share. _ Jim Shrine
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