FDA Advisory Committees Meet January 26 on Salk HIV-1 Immunogen

On January 26, two advisory committees of the FDA (the
Antiviral Drugs Advisory Committee, which considers most AIDS
drugs, and the Vaccines and Related Biological Products
Advisory Committee) will meet jointly to consider future
clinical trials of the HIV-1 Immunogen, a potential AIDS
treatment developed by Jonas Salk, M.D.

The Immune Response Corporation (IRC), of Carlsbad,
California, has already conducted a number of clinical trials
of the immunogen; 235 patients have received it in clinical
trials since 1987, with no drug-related serious adverse
events and no patients dropping out of trials due to adverse
events. Now IRC plans to run three larger trials, involving a
total of almost 5,000 volunteers. These trials, which will
last from two to four years, will test the treatment in three
groups of patients: those with T-helper count under 300,
those with 300-549, and those with 550 and above.

The HIV Immunogen is made with killed HIV, much like killed-
virus vaccines for other diseases. The current and proposed
trials are not testing it as a preventive vaccine, however,
but as a treatment for existing HIV infection. Previous
trials have shown evidence of improvement in various
immunological and other blood tests; however, they have not
been large enough to show conclusively that the treatment has
clinical benefit in delaying disease progression. The new
studies are intended to determine that, and also to validate
the use of blood-test "markers" of disease progression for
studying an immune-based treatment such as the immunogen.

Volunteers in the previous trials have shown much interest in
continuing their treatment. Those in California have long
been able to do so (due to California approval by the state's
Food and Drug Branch), but those in other states have not.
The FDA has already approved a continuation protocol, which
applies to volunteers in all states, but supplies of the
Immunogen have been limited due to manufacturing issues which
are currently being overcome.

The joint meeting will be held at the Holiday Inn, Bethesda,
Maryland, Versailles Ballrooms I through III, starting at 8
a.m. The first session, from 8:00 a.m. to 10:45 a.m. on
January 26, will be closed to the public, apparently to deal
with manufacturing issues; the rest of the meeting is
expected to be open to the public, with a public hearing from
10:45 to 11:30; persons wishing to speak should make
arrangements in advance, if possible before January 19.
[Note: the advisory committee meeting will continue on
January 27, to deal with other matters.]

For more information, contact Judy Rappaport, Salk Immunogen
Working Group of ACT UP/Philadelphia, 215/972-1454.