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Executive Summary

MICROGENESYS/WYETH-AYERST TO PROVIDE DoD WITH gp160 AIDS VACCINE free of charge to conduct a single-candidate, Phase III trial at the Walter Reed Army Institute of Research (WRAIR), Meriden, Conn.-based MicroGeneSys announced Aug. 19. The agreement brings to a close 10 months of discussions among the company, the Department of Defense and the National Institutes of Health over the optimal use of a $20 mil. congressional appropriation to DoD for a large-scale trial of MicroGeneSys' VaxSyn. The agreement was facilitated by development partner Wyeth- Ayerst's decision to reimburse the R&D firm for the costs of donating the AIDS vaccine to DoD. According to MicroGeneSys, the cost of the vaccine will rage from $5 mil.-$10 mil. over the course of the WRAIR trial. Throughout the deliberations with DoD and NIH, MicroGeneSys held that it would not be able to provide the vaccine without compensation. Last October, MicroGeneSys, with the successful lobbying of former Louisiana Senator Russell Long, received a $20 mil. earmark in DoD's fiscal year 1993 appropriations bill to conduct a large-scale Phase III trial with the gp160 vaccine. In the ensuing months, a panel of experts convened by NIH recommended that DoD conduct a comparative trial with several vaccines ("The Pink Sheet" Nov. 30, 1992, p. 8). In April, DoD agreed to transfer the $20 mil. appropriations to HHS so that the National Institute of Allergy and Infectious Diseases could conduct a multi-vaccine trial ("The Pink Sheet" April 19, T&G-11). However, the money was never officially transferred between the agencies, primarily because MicroGeneSys said it would not meet NIH's request that all participating manufacturers donate their products. As a result, the appropriation stayed at DoD, and the agency and MicroGeneSys began negotiations. In announcing the deal, MicroGeneSys stated: "We are pleased to have reached agreement with the Army to proceed with this important Phase III trial, and our company is ready to begin providing adequate doses of VaxSyn as soon as they are needed. We hope that patients can be enrolled for the trials by the end of this year and that they can start receiving the vaccine in early 1994." The trial, which will be the first Phase III study of an AIDS vaccine in the U.S., will include 5,000-10,000 HIV-infected individuals. According to the company, participants will "receive several injections of VaxSyn each year" and followed for up to four years. The study will attempt to assess the vaccine's ability to prevent clinical illness and increase longevity. VaxSyn has been studied in over 2,000 individuals enrolled in 20 trials, including a Phase III trial in Sweden that began in February. WRAIR has been involved with the clinical evaluation of VaxSyn over the last four years. Reportedly, Walter Reed researcher Deborah Birx has been selected to be the trial's principal investigator. In the past year, Robert Redfield, one of WRAIR's lead investigators with the product, came under scrutiny for allegedly misleading remarks made at the 1992 International AIDS Conference about the vaccine's beneficial effect on viral burden. After an investigation by the Army, it was found that Redfield had not inappropriately reported "his clinical or laboratory research." Reportedly, DoD may conduct a multi-vaccine trial although each manufacturer would have to donate their product as well as provide additional financing. DoD has asserted that the $20 mil. appropriation is sufficient only for single-candidate trial. Manufacturers of vaccines that might be included in a larger trial are Genentech, Chiron-Biocine, Immuno AG and Immune Response/Rhone-Poulenc Rorer. Last March, Wyeth and MicroGeneSys decided to pull out of an AIDS Clinical Trials Group 214 (ACTG) comparative study involving Genentech and Chiron-Biocine due to concerns about the trial's dosing schedule and primary endpoints. NIH officials have indicated that they have not been approached to assist with the trial. However, considering the size of the proposed study it would seem likely that DoD would use NIAID's trial networks such as the ACTG or the Community Programs for Clinical Research on AIDS.

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