Cell Genesys Inc. said Tuesday that an investigational new drug (IND)application has been filed with the FDA for the first human clinicaltrial of the company's anti-HIV T cell therapy for AIDS.The trial will be run by the National Institute of Allergy and InfectiousDiseases (NIAID) under a Cooperative Research and DevelopmentAgreement. Cell Genesys filed a drug master file with the FDA,enabling the NIAID to file the IND.Stephen Sherwin, chairman, president and CEO of the Foster City,Calif., company, told BioWorld the phase I/II trial, if approved by theFDA, will involve 40 to 45 pairs of identical twins, in which one twinis infected with HIV and the other is not. It will be conducted at theNIAID in Bethesda, Md., and is expected to start this year.T cells will be taken from the uninfected twin, genetically modified byintroducing anti-HIV universal receptors, purified and thenadministered to the infected twin. The universal receptor gene iscomprised of the CD4 protein linked to a signaling protein chain.The T cells, called CD8+, are engineered so that they recognize anddestroy human cells infected with HIV, which Sherwin said has beendemonstrated in the laboratory.One advantage of the study plan is that cells can be transferred betweenidentical twins without tissue rejection."The filing of an IND for the initial clinical trial of anti-HIV T celltherapy, our lead program in the cell therapy area, represents asignificant milestone for Cell Genesys," Sherwin said. _ Jim Shrine
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