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Executive Summary

NIH RECOMBINANT DNA ADVISORY CMTE. WILL REVIEW SEVEN GENE THERAPY PROTOCOLS at its Sept. 9-10 meeting on the National Institutes of Health campus in Bethesda, Md. None of the seven protocols slated for review by RAC at the upcoming meeting are company-sponsored, although companies are likely to be involved through the supply of materials or cell separation systems. The committee last met June 7-8 ("The Pink Sheet" June 14, p. 6). The first protocol for review is "genetically engineered autologous tumor vaccines producing interleukin-2 for the treatment of metastatic melanoma." The researchers are James Economou and John Glaspy from the University of California-Los Angeles. A mini-trend of Interleukin-2 is apparent in the RAC agenda for the September meeting. Two other protocols relate to IL-2. RAC will examine a protocol deferred from review at the June 1993 meeting pending additional information. The protocol, "immunization of malignant melanoma patients with interleukin-2 secreting melanoma cells expressing defined allogeneic histocompatability antigens," has as its investigators Tapas Gas Gupta and Edward Cohen, University of Illinois College of Medicine, and Jon Richards, University of Chicago. Their revised protocol is entitled: "pilot study of toxicity of immunization of patients with unresetable melanoma with IL-2 secreting allogeneic human melanoma cells." The other IL-2 protocol, also resubmitted, first came before RAC last March. The protocol is for a "Phase I study of transfected cancer cells expressing the interleukin-2 gene product in limited stage small-cell lung cancer." The investigators are Peter Cassileth, Eckhard Podack, Kasi Sridhar and Niramol Savaraj from the University of Miami School of Medicine. The committee will consider a protocol from NIH researcher Joyce O'shaughnessy previously submitted for review at RAC's December 1992 meeting: "retroviral mediated transfer of the human multi-drug resistance gene (MDR-1) into hematopoietic stem cells during autologous transplantation after intensive chemotherapy for breast cancer." The committee deferred approval of the protocol at its December 1992 meeting pending additional information. The committee will also consider the protocol for "a Phase I clinical trial to evaluate the safety and effects in HIV-1 infected humans of autologous lumphocytes transduced with a ribozyme that cleaves HIV-1 RNA." The researchers are Flossie Wong-Staal, Eric Peschla and David Looney from the University of California-San Diego. Additionally, RAC will review for approval "a Phase I study to evaluate the safety of cellular adoptive immunotherapy using genetically modified CD8+ HIV-specific T cells in HIV-seropositive individuals." The researchers submitted a "major modification" to their previous protocol, which would have involved HIV-positive patients undergoing allogeneic bone marrow transplant. RAC's agenda includes discussions on changing the biosafety level of a Semliki Forest Virus vector expression system; amendments to the review process for experiments involving the cloning of toxin molecules; a working group report on gene therapy transfer experiments that will be proposed exempt from RAC review; changes to the "Points to Consider" document concerning submission of protocols to RAC; and updating of the classification of microorganisms on the basis of hazard. Notice of the upcoming RAC meeting appears in the Aug. 18 Federal Register.

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