
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: FRIDAY, August 20, 1993                   TAG: 9308200016
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-4   EDITION: METRO 
SOURCE: By The Hartford Courant
DATELINE: HARTFORD, CONN.                                LENGTH: Medium

ARMY, MAKER TO BEGIN MAJOR TRIAL OF AIDS VACCINE

An agreement between the Army and a Connecticut company clears the way for the first large-scale trial of an experimental AIDS vaccine in the United States, the Army said Thursday.

MicroGeneSys Inc. has agreed to donate its vaccine for clinical tests in up to 10,000 volunteers who are infected with HIV, the virus that causes AIDS.

The clinical trial has provoked one of the most bitter public disputes in memory among scientists, many of whom argued that the vaccine is of questionable value and should not be tested without comparisons to competing products.

MicroGeneSys, a small, privately held biopharmaceutical company based in Meriden, Conn., signed the agreement Aug. 13 with the Army's medical branch, which has "initiated a large-scale clinical evaluation" of the vaccine, Capt. Bill Buckner, an Army spokesman, confirmed Thursday.

The trial is to be conducted by the Army at civilian sites throughout the nation and could begin by the end of the year, company President Franklin Volvovitz said.

The trial could take up to four years to attain results. Other details are still being worked out, Volvovitz said. But the basic strategy is to give a vaccine to people already infected with the AIDS virus to see whether it can impede or block further destruction of the immune system that results from HIV.

The tests are a victory for Volvovitz, an entrepreneur who is outside the mainstream of biotechnology. Six years ago, his company's product was the first approved by the Food and Drug Administration for testing in humans, and the agreement with the Army could keep him ahead of much larger competitors such as Genentech Inc. and Chiron Corp.

Although the donation may seem a small detail, it is the last of many issues that have delayed - and for a time seemed to doom - the trial since Congress appropriated $20 million for it in October.

That appropriation, achieved by MicroGeneSys through its Washington lobbyists, was widely seen as an end run around the government's scientific bureaucracy, which had cooled to the company's product. The move outraged many AIDS scientists, who believe that scientists, not politicians, ought to determine how to conduct scientific trials.

Also, they said the MicroGeneSys vaccine - known as gp160, after the HIV protein it targets - had not proven itself in lesser trials to be ready for large-scale testing on its own.

A panel of scientists convened by the National Institutes of Health recommended in November that the money be used in a comparative trial of multiple vaccines, made by competitors of MicroGeneSys.

It also called on vaccine makers to donate their vaccines, as is normally done when experimental drugs are tested. Every manufacturer except MicroGeneSys said it would do so.

This spring, the Army rebuffed the National Institutes, its rival in medical research, and said it would test only gp160.

That decision was reversed by Defense Secretary Les Aspin. The Army agreed to surrender the $20 million to the Institutes.

The White House then apparently changed course, leaving the money and the decision with Army researchers.

by CNB