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Executive Summary

BRISTOL-MYERS AIDS VACCINE (V-ENV5) IS AT "ADVANCED" PRECLINICAL stage in chimpanzees, the company reports in an Oct. 21 proposal to the Public Health Service for collaboration on vaccine development. The proposal was submitted by Bristol-Myers and its DNA subsidiaries Genetic Systems and Oncogen in response to a PHS notice published in the Aug. 22 Federal Register seeking private sector partners for the "development, testing, production and distribution of a vaccine for the prevention of AIDS." PHS said it has received "several" proposals to date. Bristol-Myers says that it has been "able to construct a recombinant virus (v-env5) that expressed and correctly processed the envelope antigens of HTLV-III/LAV. . . using vaccinia virus as a vector." The firm completed preclinical studies with the DNA virus in two strains of mice and in macaques, and "is presently at an advanced stage of preclinical testing in chimpanzees," the proposal states. As part of the collaborative development program with PHS, Bristol is seeking some product liability protection. The company contends that "Bristol cannot undertake this substantial at-risk investment under the current tort system. In addition to the liability exposure, potential litigation costs, both in terms of time and money, create strong disincentives for any manufacturer to develop an AIDS vaccine." Reporting the results of mice studies, the proposal states that two strains of the animals, one inbred and one outbred, were inoculated with the recombinant virus. Bristol-Myers said that enzyme linked immunosorbant assay "data on the 6-week serum samples showed that recombinant v-env5 seroconverted 95% of the [inbred] mice and 100% of the [outbred] mice." An additional test in inbred mice found that all mice "immunized with the recombinant viruses produced antibodies that reacted with HTLV-III/LAV envelope glycoprotein gp41." Serum from some of the mice, the proposal adds, "also recognized gp150 and gp110, indicating the ability of this recombinant virus to elicit an immune response to all major glycoproteins of HTLV-III/LAV." Similar studies in macaques "demonstrated that, although only two animals showed seroconversion after primary inoculation, all animals seroconverted after the second immunization," the proposal states. "All animals that received two inoculations showed strong antibody reaction to gp41. In addition, four [out of the eight macaques receiving two injections] also produced antibodies which reacted strongly with gp110," Bristol-Myers said. To facilitate the collaborative program, Bristol suggested that an AIDS Vaccine Testing Committee be established. "Such a committee could be comprised to scientists from NIH, FDA, and Bristol, who would jointly develop or review the clinical protocols and would monitor clinical testing," the proposal states. "This committee would also function collaboratively to review and evaluate the data obtained in preclinical animal model experiments to date by investigators at Bristol and the PHS." According to the PHS notice, "collaborative agreements will be negotiated on a case-by-case basis." Under the agreements, the notice states, PHS "may provide: (1) patent licensing (both exclusive and nonexclusive), (2) research results, (3) scientific knowledge, (4) laboratory facilities, (5) animal models and animal testing, (6) assistance in the formulation of clinical trials, and (7) other assistance, as appropriate." Funding assistance will not be provided by PHS. Principal Bristol collaborators for AIDS vaccine projects would include senior scientists and directors at Oncogen (acquired by Bristol in its 1985 purchase of Genetic Systems), the CEO and the VP-Research at Genetic Systems, and researchers in the infectious disease area at Bristol-Myers Company. Bristol cites its record of working with the Public Health Service on cancer chemotherapeutics as a factor in support of its application for the AIDS vaccine collaboration.

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