Answers
07/23/1987

<TITLE>Aids Update </TITLE>
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T87-34
July 23,1987


             UPDATE ON EXPERIMENTAL AIDS THERAPIES AND VACCINES 


    The fight against AIDS has been designated by President Reagan to be the
nation's number one health priority.  FDA is one agency among several in the
Public Health Service and the rest of the Department for Health and Human 
Services that are leading the fight against this disease.  In order to keep 
FDA headquarters and field staff abreast of the latest developments in the
agency's AIDS efforts, the following information is being provided to help
answer questions about potential AIDS therapies and vaccines now being
studied.  This Talk Paper updates T87-22 (April 9,1987).

NEW DRUG APPLICATIONS (NDA) 
    FDA has given all potential AIDS drugs a 1-AA classification in the 
Center for Drugs and Biologics's drug priority classification system.  This 
assures them the very top priority in the agency's review process.  The 
agency's expedited review of zidovudine (marketed as Retrovir and more
commonly known as AZT), which became the first approved treatment for AIDS, 
served as the prototype for the new 1-AA classification.
    The agency reviewed and approved zidovudine's new drug application (NDA)
in less than four months after its submission.
    There are currently no new drug applications for AIDS drugs pending 
before the agency.

INVESTIGATIONAL NEW DRUG (IND)
    FDA has approved more than 100 on-going human studies to test potential 
AIDS drugs.  In many cases, the FDA has granted permission to begin these 
trials within five days of receiving an application.
    At present these studies involve nearly 40 different anti-viral or
immuno-modulating drugs (anti-virals act directly against the virus while 
immuno-modulators are intended to boost the body's own defense system and 
combat the disease).  In several cases, separate human trials are being 
conducted with the same proposed AIDS therapy to test its effect on 
different AIDS conditions.  In a few cases, two or more experimental
therapies are going used in combination.
    Under the Freedom of Information Act FDA employees are prohibited from
publicly discussing or acknowledging the status of drugs currently under
agency review.  Due to the intense public interest in AIDS, however, many of
the sponsors of experimental AIDS therapies now undergoing FDA-sanctioned 
clinical testing have made some information about their therapies publicly
available.  The following is a list of potential AIDS therapies acknowledged
by the sponsor to be now under study.  Requests for additional information
on any of these products should be directed to the IND's sponsor. 

POTENTIAL IMMUNO MODULATING AGENTS
EXPERIMENTAL TREATMENT          SPONSOR 

Thymopentin                     Ortho Parmaceuticals, Raritan, N.J. 
Thymostimuline                  Serono Laboratories Inc., Randolph, Mass. 
Methionine-enkepalin            National Jewish Hospital, Denver, Colo. 
AS-101                          Scientific Testing Inc., New Brunswick, N.J.
Isoprinosine                    Newport Pharmaceuticals, Newport Beach,Calif. 
Alpha Interferon*               Hoffmann-La Roche Inc., Nutley, N.J.
Gamma Interferon*               Genentech Inc., San Francisco, Calif. 
Imreg-I*                        IMREG Inc., New Orleans, La.
Interleukin-II*                 Hoffmann-La Roche Inc., Nutley, N.J.
Ampligen*                       HEM Research, Rockville, MD.
Immune Globulin IG-IV           Sandoz Pharmaceuticals Corp., 
                                East Hanover, N.J.
                                Alpha Therapeutics, Los Angeles, Calif. 
Anti-alpha interferon serum*    Advanced Biotherapy Concepts Inc.,
                                Los Angeles, Calif. 

*These therapies are considered biologic products.

                                     ---

POTENTIAL ANTI VIRAL AGENTS 

EXPERIMENTAL TREATMENT          SPONSORS

Ansamycin                       Adria Laboratories, Dublin, Ohio
Ribavirin                       Viratek/ICN Pharmaceuticals, Costa Mesa CA
DDC (Dideoxycytidine)           Hoffmann-La Roche Inc., Nutley, N.J.
HPA-23                          Rhone-Poulenc, Monmouth Junction, M.J.
Al 721                          Matrix Laboratories, New York, N.Y. 
Foscarnet                       National Inst. for Allergies & Infectious 
                                Disease, Bethesda, Md.
UA001                           Ueno Fine Chemicals Industry Ltd., N.Y. N.Y.

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