The Recombinant DNA Advisory Committee (RAC) of theNational Institutes of Health on Monday approved a protocol forgene therapy of HIV from Viagene Inc., a company that receivesno grants from NIH and therefore falls outside of the RAC'sjurisdiction.

Steven Mento, the San Diego company's vice president ofresearch and development, told BioWorld, "We hope to be ableto expand the clinical testing to multiple sites, and some mayhave NIH funding, so we want to bring the protocol before thecommittee at this stage." In fact, under questioning, Mentoagreed not to go forward should the RAC vote against approval.

The protocol concerned safety and biologic effects of a murineretroviral vector encoding HIV-1 genes in asymptomaticcarriers, an approach that might prove useful for primingpatients' immune systems.

Some committee members worried about the possibility thatthe murine retrovirus could interact with HIV to create widerinfectivity, and wanted to go into executive session toexamine the vector, which is proprietary. "If they're asking fora good housekeeping seal, don't they have to turn in theirtupperware?" asked RAC member Alex Capron, a bioethicist anda professor of law at the University of Southern California.

But RAC member Susan Hirano, associate scientist in theDepartment of Plant Pathology at the University of Wisconsin,praised the protocol and the company's response to questionsto the point where Committee Chair LeRoy Walters, director ofthe Center for Bioethics at the Kennedy Institute of Ethics atGeorgetown University, said, "I'm not getting any feeling wecan't (approve) it."

As committee members argued over potential dangers fromretroviral promiscuity, gene therapy pioneer French Anderson,who is not a member of the committee, interjected that anylikely scenarios "would be therapeutic, not dangerous," as "theamphitrophic envelope is exceedingly sensitive to humancomplement. We replaced 22 percent of the blood volume ofmonkey with pure virus," he said.

Leonard Post, vice president of experimental therapy, Parke-Davis Pharmaceutical Division, proposed that the vectorformulation be reviewed by A. Dusty Miller, of the Program inMolecular Medicine at the Fred Hutchinson Cancer ResearchCenter. Miller, confident of its safety, responded, "I don't evenwant to see it." The vote that followed was 16-0, with twoabstentions.

Several AIDS activists present praised Viagene's appearancebefore the RAC. The company's openness makes it possible foractivists to provide valuable information to Viagene, G'DaliBraverman of ACT UP/Golden Gate, who works on treatmentissues, told BioWorld.

"We were discussing with Mento this morning specificallywhich assays should be used to measure blood or bone marrow,virologic measurements, and which populations to study,"Braverman said. These discussions are important, Mento toldBioWorld.

The AIDS activists currently are lobbying to gain a position onthe RAC.

Overall, it was a long day at RAC. Eight protocols wereapproved: three for cancer, three for genetic diseases and twofor HIV. According to Anderson, the approval rate was notsurprising because the mediocre protocols get weeded outbefore they reach the RAC.

Anderson also observed that the numbers of protocols for eachdisease reflect that cancer is still where the action is. Fiveprotocols for cancer are being considered today.

-- David C. Holzman Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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