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SOMATIX GM-CSF/GENE THERAPY RENAL CANCER TRIAL CLEARS RAC

Executive Summary

SOMATIX GM-CSF/GENE THERAPY RENAL CANCER TRIAL CLEARS RAC during the National Institutes of Health's Recombinant DNA Advisory Committee meeting March 1. The protocol, submitted by lead investigator Jonathan Simons, MD, Johns Hopkins University, is a randomized Phase I dose-escalation study which seeks to treat metastatic renal cell cancer patients with autologous tumor cell injections of cells transduced with the coding sequence for granulocyte-macrophage colony stimulating factor. The protocol employs a novel viral vector (MFG) provided by Somatix Therapy Corp. Somatix plans to submit an IND for the trial, the company's first, within the next few months. "Although our initial target is renal cancer, we believe that this treatment may be effective in fighting many other cancers," Somatix said March 2. "It is believed that the genetically modified cells may be able to stimulate the immune system" to recognize tumor cell antigens "resulting in the elimination of tumor cells with these same antigens throughout the body." RAC reviewed a total of 10 protocols during the March 1-2 meeting. Two cystic fibrosis trials, one using vectors supplied by Genetic Therapy, Inc., were unanimously approved. Two trials proposing to alter bone marrow with the multiple drug resistance (MDR) gene in an attempt to reduce myelosuppression associated with Bristol-Myers Squibb's Taxol were deferred by the committee. Also deferred by the committee was a study proposing to transduce malignant melanoma patients' tumor cells with coding for gamma interferon using vectors supplied by Viagene. The next RAC meeting is scheduled for June 7-8. Three other gene transfer protocols using GTI vectors were approved by the committee. One, sponsored by Kenneth Culver, MD, University of Iowa, is similar to an ongoing glioblastoma trial sponsored by GTI. Two gene marking trials to be conducted by St. Jude Children's Hospital researcher and GTI collaborator Malcolm Brenner, MD, were also cleared by RAC. On March 2, the committee adopted a 10-point procedures guide for expedited review of gene therapy protocols. The proposal will be forwarded to NIH Director Bernadine Healy for publication in the Federal Register. The committee's final draft of the document retains the substance of the policy originally endorsed by RAC in January: the same standard used by RAC in its reviews should be applied to expedited reviews ("The Pink Sheet" Jan. 18, T&G-2). RAC developed the policy after a compassionate use approval was granted for gene therapy treatment of a San Diego glioblastoma patient by NIH and FDA ("The Pink Sheet" Jan. 4, T&G-4). The sponsors of the San Diego protocol, San Diego Regional Cancer Center researchers Robert Sobol, MD, and Ivor Royston, MD, were asked by RAC to submit the information used by FDA and NIH to grant the compassionate use approval for the March meeting. Although the committee did not vote on the issue, several RAC members declared that they would not have voted to support approval of the single-patient trial based on the information submitted.
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