Monday, June 14, 1993
WASHINGTON - Entry into the clinic of Viagene Inc.'s HIV immunotherapeutic gene therapy will bolster an emerging commercial gene therapy pipeline that could begin producing products within four to five years.
The NIH Recombinant Advisory Committee (RAC) approved Viagene's gene therapy protocol last week. Although the RAC has approved more than 50 protocols, Viagene's immunotherapeutic is only the third corporate-sponsored project to reach the IND stage. The company filed its application with the FDA last month.
Biotech companies now are rushing to get into the clinic with gene therapy, said Robert Fine, assistant vice president of Nomura Research Institute of America Inc. With RAC and FDA support of gene therapy, development of products is "certainly on an accelerated curve."
Products in pipeline
Last year, Genetic Therapy Inc. (GTII) began Phase I trials of its in vivo treatment for brain tumors, which involves transfer of the gene for enzyme thymidine kinase to residual tumor cells to make them susceptible to the antiviral drug ganciclovir. Also last year, Targeted Genetics Corp. began Phase I trials of its retroviral vector, which modifies HIV-specific T cells after they have been removed from an HIV-infected patient who is undergoing bone marrow transplantation for AIDS-related lymphoma. The T cells are increased in number and reinfused.