Subject: Du Pont, Hem End Study of Ampligen As AIDS Remedy 
Date: Published: 10/14/88 69 lines
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology and Medicine:  
    Du Pont, Hem End
    Study of Ampligen
    As AIDS Remedy
    ----  
    By Michael Waldholz
    Staff Reporter of The Wall Street Journal

    A large study of the experimental AIDS drug Ampligen was
 terminated this week after its sponsors decided there was
 insufficient evidence that the drug is effective.
    Du Pont Co. and Hem Research Inc., a small Philadelphia
 company, ended their jointly sponsored study of Ampligen
 following an "interim" analysis last week of data from the
 study.  In a letter to doctors conducting the 330-patient
 study at 11 medical centers, officials of Du Pont and Hem
 said that a review of data "failed to show any difference
 between Ampligen and placebo that would justify continuation
 of the study."
    The study's termination casts a widening shadow over a
 drug which had received considerable attention last year as a
 potential treatment for acquired immune deficiency syndrome.
 The interest followed the release of some initial reports
 that Ampligen boosted the immune system of patients with
 AIDS-related complex, or ARC, an early stage of the disease.
 There was some evidence that use of the drug blocked or
 slowed progress from ARC to AIDS. 
    Following the early reports, Du Pont, a Wilmington, Del.,
 chemical and pharmaceuticals company, formed a joint
 agreement with Hem, which developed Ampligen, to produce the
 drug and conduct further studies.  But in late August, the
 Wall Street Journal reported that Du Pont suddenly ended its
 involvement in the joint venture when a review by its
 officials of several studies indicated that the drug wasn't
 showing a significant effect.
    But officials at Hem, a closely held company whose only
 product is Ampligen, argued that there was no evidence that
 the drug was ineffective.  Hem said it would continue the
 330-patient study.  Du Pont agreed to continue supplying the
 drug for the study.
    Now, in the letter this week to doctors conducting the
 study, officials from Hem and Du Pont said that about the
 same number of ARC patients taking a placebo and those taking
 Ampligen had progressed to AIDS. In telephone interviews,
 officials at Hem and Du Pont said that in test tube and
 animal studies Ampligen continued to show biological activity
 against the virus that causes AIDS. Ian Brick, chairman of
 Hem, said the company recently had doubled the dose of
 Ampligen to 400 milligrams in some patients in a separate
 study, and he expected to have results of an analysis of
 whether the drug worked better at the larger dose.
    "I think Ampligen has an effect," Mr. Brick said.  "Perhaps
 we have yet to find the proper dose."  Mr. Brick said that
 patients in the terminated study would be given the option of
 continuing to receive Ampligen.
    James Wells, a Du Pont official involved in the Ampligen
 project, said Du Pont had decided that the chances of getting
 Ampligen approved by the government didn't justify the kind
 of investment required, and that the company felt its
 resources could be better used to pursue other AIDS projects.

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