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Pharmaceutical industry

Cell Genesys Completes Patient Enrollment for Phase I Portion of Anti-HIV T Cell Gene Therapy Trial for AIDS

Strategic Insights

— 2 min read

Cell Genesys, Inc. has completed patient enrollment for the Phase I portion of its initial trial of anti-HIV T cell gene therapy for AIDS. The company's novel therapy involves genetically modifying killer T cells from the human immune system to treat viral infection and cancer. The trial, which began last October at the National Institute of Allergy and Infectious Diseases, involves 29 patients and aims to assess the antiviral effects of the therapy. The company plans to file an Investigational New Drug (IND) application with the FDA by the end of 1995 to begin testing the efficacy of individualized anti-HIV T cell gene therapy in a Phase II clinical trial.

Key Takeaways:

  • Cell Genesys has completed patient enrollment for the Phase I portion of its anti-HIV T cell gene therapy trial for AIDS, enrolling 29 patients.
  • The trial began last October at the National Institute of Allergy and Infectious Diseases and involves pairs of identical twins where one twin is infected with HIV and the other is not.
  • In the Phase II portion of the trial, approximately 40 pairs of HIV-infected twins will receive genetically modified or unmodified T cells in a randomized, controlled trial.
  • Cell Genesys' anti-HIV T cell gene therapy involves genetically modifying killer T cells to recognize and destroy HIV-infected cells, addressing the persistence of the virus in infected cells.
  • The company plans to file an IND application with the FDA by the end of 1995 to begin testing the efficacy of individualized anti-HIV T cell gene therapy in a Phase II clinical trial.
  • Cell Genesys is genetically engineering the human immune system to create innovative therapies for serious diseases, including cancer and viral infections.
  • The company's lead program, anti-HIV T cell gene therapy for AIDS, is currently in human clinical testing.
  • Human monoclonal antibodies are being developed through the company's Xenotech joint venture.

Statistics:

  • 29 patients have been enrolled in the Phase I portion of the anti-HIV T cell gene therapy trial for AIDS.
  • 40 pairs of HIV-infected twins will receive genetically modified or unmodified T cells in the Phase II portion of the trial.
  • The trial is expected to last for a year, with repeated doses of cells administered during that time.
  • Cell Genesys aims to file an IND application with the FDA by the end of 1995.
  • The company is currently in human clinical testing with its lead program, anti-HIV T cell gene therapy for AIDS.

Sources:

  • PR Newswire (Sept. 7, 1995)
  • Cell Genesys, Inc. (Nasdaq: CEGE)

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