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HIV Gene Therapy

FDA Clearance Received for Second Phase II Trial

Published in Gene Therapy Weekly, May 20th, 1996

Cell Genesys, Inc., Foster City, California, announced that it received clearance from the U.S. Food and Drug Administration (FDA) to open for enrollment a second Phase II clinical trial for the company's AIDS gene therapy based on an Investigational New Drug application (IND) filed in March 1996.

The trial tests the company's commercial approach to this therapy, in which a patient's own T cells are collected, genetically modified to recognize and destroy HIV infected cells and returned to that same patient as AIDS gene therapy.

Drs. Steven Deeks and Paul Volberding, clinical investigators at the University of California, San Francisco and San...

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