Subject: Researchers to Report Results of Study On Ampligen
Date: Published: 12/4/87 105 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

    Researchers to Report Results of Study
    On Drug Intended to Delay Onset of AIDS
    ---
    By Marilyn Chase
    Staff Reporter of The Wall Street Journal

    Researchers at Hahnemann University in Philadelphia soon
 will present preliminary studies on Ampligen, a new drug they
 believe may delay the onset of acquired immune deficiency
 syndrome, AIDS, in people infected by the virus.
    David R. Strayer, a professor in Hahnemann's department of
 neoplastic diseases, is scheduled to present the findings
 tomorrow at a meeting of the American Society of Hematology
 in Washington, D. C. 
    The Ampligen study is expected to draw an unusual level of
 scientific scrutiny because of the intense interest in the
 drug by AIDS patients and their advocates.
    Ampligen, a drug fashioned from double-stranded RNA,
 ribonucleic acid, is being developed as a joint venture of
 closely held HEM Research Inc. of Rockville, Md., and Du Pont
 Co. of Wilmington, Del.
    In composite trading on the New York Stock Exchange
 yesterday, Du Pont closed at $76.75, down $1.25.
    Dr. Strayer said that after treatment with Ampligen, a
 group of 25 patients with AIDS-related complex, ARC, or with
 lymphadenopathy -- a condition characterized by swollen
 glands -- often found in pre-AIDS patients -- experienced a
 stabilization of their immune systems.
    He said this stabilizing effect was seen in the increase
 in the number of T4 cells, which are key protectors of the
 immune system.  Patients overall experienced a 4.5% rise in
 the number of cells after four months of treatment, 8% after
 eight months, and 17% after a year.  However, he noted only
 six patients had been on Ampligen for a full year, so the
 sample size was very small.
    In addition, the patients in the Ampligen study had
 relatively healthy immune systems at the start of the trial,
 with a mean T4 count of 332.  (By contrast, the drug AZT,
 which is used to treat AIDS and severe ARC patients, is
 approved only in patients whose T4 count has dropped below
 200.)  
    In a normal, healthy individual, T4 cells can range from a
 high of 1400 to a low of 700.  In most AIDS patients, the
 level of T4 cells has declined to between 50 and 100.  Most
 ARC patients have a T4 count between 50 and 200, according to
 Jerome Groopman, a researcher at New England Deaconess
 Hospital in Boston.  The Ampligen study included some patients
 whose T4 cells were as high as 400, with the mean at about
 332.
    There weren't any "clinically significant" side-effects,
 said Dr. Strayer, but he noted that some patients experienced
 mild muscle aches and fatigue.  He added that more patients,
 however, experienced a lessening of fatigue, along with
 abatement of night sweats and diarrhea.
    Dr. Strayer acknowledged in an interview that the
 healthier the subjects, the more significant Ampligen's
 effects, but he emphasized the aim was to prevent illness in
 infected people, not cure AIDS. 
    He said patients also experienced a 26% decrease in the
 levels of the AIDS virus in their blood.  Overall, he added,
 the patients' weight remained stable, and about 80%
 experienced a restoration of the ability of their immune
 system to react to a certain skin test, which is commonly
 administered by researchers to measure the strength of the
 immune system.
    The drug didn't seem to affect symptoms of patients
 already ill with AIDS, however.  Of five patients with AIDS
 who were treated with Ampligen, one died after a second bout
 of pneumonia.  Four AIDS patients in the study who had
 previously had Kaposi's Sarcoma, an AIDS-related cancer, all
 experienced a worsening of their cancer and were removed from
 the study, Dr. Strayer said.
    "We're not making a claim for this drug (Ampligen) for
 AIDS or for anything right now.  What we're looking at is a
 stabilization of T4 cells which would probably have gone down
 if untreated," Dr. Strayer said.  "We're hoping that you could
 delay progression to AIDS by stimulating the immune system
 and by inhibiting the virus."
    But several outside researchers, including Mr. Groopman,
 contended the Ampligen study subjects were too few, and too
 healthy, and the claimed improvements too slight to draw any
 conclusions whatever.
    "With the small sample size, and the relatively high
 T4-cell counts, it's hard to tell if there's any real immune
 improvement," said Mr. Groopman.  He said he had followed a
 number of similarly healthy ARC patients "who remain stable
 with no treatment at all."
    "This doesn't mean the drug isn't good," he added, "but
 they're obligated to do a much larger trial" to give their
 claims a fair test.
    Indeed, Dr. Strayer said the study currently is being
 expanded to eight from three centers in a test of Ampligen
 against a placebo, or medically inactive substance, to
 determine whether the treated patients in fact fare better.
 That test is expected to take about a year to complete.

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