Food and Drug Administration, U.S. Department of Health and
The Food and Drug Administration today approved the use of
alpha interferon to treat Kaposi's Sarcoma -- a systemic cancer
which primarily affects AIDS patients. The approval is based
in part on a study by scientists at the National Institute of
Allergy and Infectious Diseases. (Results of this study will be
published in the Nov. 26 issue of the medical journal Lancet.)
Alpha interferon is a natural protein present in the body in
small amounts. In recent years, gene-splicing techniques have
permitted enough of the substance to be produced for research
and therapy. Alpha interferon treatments have previously been
shown effective against a rare leukemia and genital warts.
FDA Commissioner Frank E. Young, M.D., Ph.D, said today's
announcement marks an important advance in the fight against
AIDS-related disease, as well as a practical application of
biotechnology. He said, "This new use for alpha interferon
shows biotechnology's emerging role in helping modern medicine
fight some of the most serious diseases which plague mankind.
The revolutionary gains being made through biotechnology can
improve the nation's health and provide new hope to patients
with AIDS and other serious diseases."
The interferons, or hormone-like proteins, were discovered in
the late 1950s as naturally occurring anti-infective agents
present at low levels within the body.
Quantities for research and treatment were made possible by
recombinant DNA or gene-splicing techniques. In gene-splicing,
a gene containing the code for alpha interferon is inserted in
harmless bacteria, which then produce large amounts of the
Through the classification of different types of interferons,
the identification of their specific receptor sites in the
human body, and the development of gene-splicing techniques in
the last decade, it is now possible to produce the amounts of
the specific substance needed to make alpha interferon a
practical therapeutic agent.
Schering Corp. of Kenilworth, N.J., and Hoffmann-La Roche of
Nutley, N.J., will market slightly different molecular versions
of the licensed alpha interferon treatment for this indication
under the Intron-A and Roferon brand names, respectively. Both
of these genetically engineered alpha interferon products were
first approved in June 1986 as treatments for hairy cell
leukemia -- a rare adult form of leukemia. In June 1988,
Intron-A was also approved for treating genital warts.
Kaposi's Sarcoma is ordinarily a rare cancer that affects older
men of Mediterranean descent. However, the incidence
dramatically increased in the early 1980s, with nearly all the
newly reported cases involving young, homosexual men. This
rise in the incidence of Kaposi's Sarcoma was one of the first
important clues that led to uncovering the spread of AIDS.
Kaposi's Sarcoma is most often manifested by the appearance of
large purplish lesions on the skin, but internal lesions can
also develop. The form of Kaposi's Sarcoma associated with
AIDS tends to spread far more extensively throughout the body.
Although the disease is rarely the actual cause of death for
AIDS patients, it can spread throughout the body and greatly
weaken the patient's physical condition.
Standard treatments for Kaposi's Sarcoma have included
chemotherapy and radiation treatments. In AIDS patients,
however, chemotherapy can further raise the patient's risk of
acquiring severe opportunistic infections. Radiation therapy
can treat localized tumors, but not the systemic tumor growth
that often occurs in AIDS patients.
In several human studies, 40 to 45 percent of certain patients
with Kaposi's Sarcoma who received high doses of alpha
interferon responded with a significant reduction in the size
of their tumors. These patients tended to be at less advanced
stages of AIDS -- they tended to have T4-helper cell counts of
above 200 -- and tended to not have experienced any of the
severe opportunistic infections that are often associated with
AIDS. T4-helper cells are the blood cells that play an
essential role in the body's immune system. Healthy people
normally have T4-helper cell levels of 800 to 1,000, while
people at advanced stages of AIDS can have T4-helper cell
counts of less than 200.
The studies demonstrating the safety and efficacy of alpha
interferon in treating Kaposi's Sarcoma involved the efforts of
industry, investigators at several universities and
investigators at the National Institute of Allergy and
Infectious Diseases. These studies were critical in
determining the patient population likely to benefit from alpha
Anthony S. Fauci, director of the National Institute of Allergy
and Infectious Diseases, said, "One of these studies, conducted
by Dr. H. Clifford Lane, demonstrated that alpha interferon was
an effective anti-Kaposi's Sarcoma agent in patients with less
advanced stages of immunologic decline. Dr. Lane's study also
found evidence that alpha interferon may, to some extent,
diminish AIDS virus activity."
Dr. Fauci said that the National Institute for Allergy and
Infectious Diseases is conducting additional studies of alpha
interferon. Volunteers at early stages of HIV infection are
being sought for a study comparing treatment with alpha
interferon plus zidovudine (commonly known as AZT) to treatment
with zidovudine or alpha interferon alone. Interested
individuals should call Victoria Davey, R.N., at (301)
Patients at more advanced stages of AIDS tend to be less
responsive to alpha interferon treatment.
Reported adverse reactions to alpha interferon include flu-like
symptoms and other reactions of varying severity.
Broadcasters: Kaposi's is pronounced with the emphasis on the
first syllable -- KAP-o-sees.