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Executive Summary

BRISTOL-MYERS SQUIBB's BVaraU FOR HERPES-ZOSTER IN PHASE III trials in conjunction with the National Institutes of Health, BMS Director of Clinical Research for Infectious Diseases Jeffrey Sherman, MD, reported at NIH's technology transfer forum on Nov. 14. BVaraU (bromo-vinyl arabinosyl uracil) studies in AIDS patients and other immunocompromised patients, such as the elderly, began early this autumn at two sites. Approximately 180 patients are being enrolled at each site, NIH Antiviral Research Branch Chief Catherine Laughlin, MD, told the forum. While the trial is being sponsored by Bristol-Myers Squibb, which holds an exclusive license for BVaraU, the protocol for the study was jointly designed by BMS scientists and researchers from Laughlin's lab. NIH also will provide clinical support and regulatory expertise during BVaraU's development, Sherman said. The BVaraU trial was one of several NIH/industry joint research efforts that were highlighted at the meeting to show the advantages of such collaboration in drug development. Sherman said Bristol-Myers Squibb decided to consult with NIH after the company realized how difficult it would be to assemble and care for a Zoster-stricken cohort. Herpes-zoster patients are located in a wide geographic area, many of them are elderly and require round-the-clock care, and their condition must be diagnosed and treated promptly for a therapy to show any efficacy, Sherman said. NIH, with its established clinical trials networks and experienced clinicians, was one of the few research facilities equipped to coordinate and carry out such a trial, Sherman stated. In addition, he said Bristol-Myers was attracted to the Antiviral Research Branch's "extensive experience" with antiviral drug development and by NIH's close working relationship with FDA. Laughlin also described NIH's pre-clinical partnership with a small start-up company, Shaman Pharmaceuticals, which is based in San Carlos, Calif. The company is dedicated exclusively to identifying and commercializing native remedies used by tribal medicine men, called shaman. The firm recently approached NIH with a compound it believed could be used as a treatment for influenza. Although the compound, SP303, was eventually proved to be ineffective against influenza, Laughlin said her branch's extramural SCREEN program found that SP303 "has substantial activity against respiratory syncytial virus." Pre-clinical trials in cotton rats and primate models conducted at NIH also have confirmed the drug's activity against RSV, and, according to Laughlin, Shaman was recently granted an IND to begin testing the drug in humans. The only other drug on the market for respiratory syncytial virus is ICN Pharmaceuticals' Virazole (ribavarin), which Laughlin described as having "many problems." In clinical studies, ribavarin has been associated with several adverse events, including pulmonary deterioration and cardiac arrest. The drug also has been shown to have teratogenic effects in all species in which it has been tested. Another example of industry/NIH collaboration is the cooperative research and development agreement (CRADA) NIH has with Chiron for the development of a recombinant vaccine for the prevention and treatment of genital herpes. Stephen Strauss, MD, Chief of NIH's Medical Virology Section, reported that his lab, in conjunction with Chiron, recently completed Phase II trials on 24 patients. He said the recombinant vaccine "does boost antibody response in patients infected with herpes simplex I and II." The vaccine is now being tested for symptomatic improvement in a population with chronic, recurring genital herpes.

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