Subject: FDA Clears Human Tests of Vaccine Against AIDS
Date: Published: 8/18/87 74 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   FDA Clears Human Tests of Vaccine
   Against AIDS Made by MicroGeneSys
    ---
   By Marilyn Chase and Edward Sussman
   Staff Reporters of The Wall Street Journal

   The U. S. Food and Drug Administration has approved human
clinical tests of an experimental AIDS vaccine being
developed by West Haven, Conn.-based MicroGeneSys.
   The tests would be the first U. S. -approved human clinical
trial of a vaccine against AIDS, or acquired immune
deficiency syndrome.  News of the forthcoming test, first
published in the Washington Drug Letter, a weekly trade
publication, subsequently was confirmed by a federal health
official.  Executives of the closely held company, which has
about 30 employees, were said to be on a retreat and
unavailable for comment.
   The MicroGeneSys vaccine reportedly uses a gene-spliced
version of the outer coat of the AIDS virus.  The protein
coat, known as gp 160, would be used to "trick" the body into
mounting an immune defense against the real virus, should
exposure occur later on.  MicroGeneSys makes the vaccine in a
culture of insect cells engineered to manufacture the
proteins in quantity, sources said.
   MicroGeneSys is one of many companies currently working on
developing an AIDS vaccine.  Two of these groups -- the
Oncogen division of Bristol-Myers Co., and Houston-based
Institute of Immunological Disorders in concert with George
Washington University -- have applied for FDA approval to
begin tests, an agency spokesman said.  Other companies
working on AIDS vaccines include Genentech Inc., Chiron Inc. 
in collaboration with Ciba-Geigy Corp., Repligen Corp. with
Merck & Co., and Cambridge Bioscience Corp. with Institut
Merieux of France.
   The forthcoming tests are expected to be announced today
in Washington by the company and the National Institute of
Allergy and Infectious Diseases, or Niaid, a unit of the
National Insitutes of Health.  Niaid has a network of six
university-based vaccine evaluation units that include
Vanderbilt University, Baylor College of Medicine, the
University of Rochester, Johns Hopkins University, the
University of Maryland and Marshall University in Huntington,
W. Va.
   These test sites have evaluated vaccines for everything
from pertussis (whooping cough) to flu over the years.  But
recently the health institute added a supplement to their
contract, specifically enabling them to study AIDS vaccines,
 a spokeswoman for Niaid said.  That move sparked a flurry of
rumors last week that tests were imminent.
   Once tests begin, however, there's no guarantee of success
in preventing the fatal immune disorder that has so far
struck some 40,000 Americans and killed more than half of
them.  Indeed, early tests on animals by several groups have
been disappointing.  Given to chimpanzees, some early vaccine
preparations sparked the production of antibodies, but failed
later to prevent infection when the animals were exposed to
the virus.
   Another difficulty is anticipated in selecting the group
to be tested, since many people at risk for AIDS already have
been exposed to the virus.
   Earlier this year, French scientist Daniel Zagury
disclosed that he had performed human tests, injecting
himself and other French and African volunteers with an
experimental AIDS vaccine.

[This article is made available here by Dow Jones Co. for the 
personal and non-commercial use of callers to this bbs, in the 
hope that it will be of some help to those who are suffering 
from the disease and others who are seeking to help them.]