Subject: Immune Response Trials of Vaccine For HIV Delayed
Date: Published: 3/6/92 (91 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Medicine:
    Immune Response
    Trials of Vaccine
    For HIV Delayed
    ---
    By Sonia L. Nazario
    Staff Reporter of The Wall Street Journal

    Immune Response Corp. clinical trials of its vaccine
 against human immunodeficiency virus infection for uninfected
 individuals have been delayed because of "product liability"
 concerns over injecting such patients with a killed human
 immunodeficiency virus.
    Immune Response's president had indicated last June that
 clinical trials of uninfected patients using the company's
 HIV vaccine would begin by the end of 1991.
    And Immune Response has long maintained that a vaccine,
 based on an approach first suggested by polio pioneer and
 Immune Response founder Jonas Salk of using whole but
 inactivated AIDS viruses to inoculate people against the
 dreaded disease is completely safe.  The company has
 highlighted its safe completion of testing of the vaccine on
 humans already infected with the AIDS virus.
    But many in the medical community have long disagreed.
 Some believe that a glitch in quality control in the
 production of the vaccine or other factors make it too risky
 for a mass-prevention strategy.  As a parallel, they often
 note that the polio vaccine has at times given people the
 polio disease.
    Where other researchers use genetically engineered or
 synthetic virus proteins, Dr. Salk has chosen to use live
 virus killed with gamma radiation.
    A spokesman for the company said that "we intend to do the
 study," on uninfected individuals but that some "logistical
 issues" involving product liability have to be worked out
 first and have dragged on longer than expected.  It's unclear
 when the company will press forward with the study, which
 would launch clinical trials of the company's HIV vaccine on
 10 to 15 uninfected patients in California.  That cadre of
 patients would include Dr. Salk.
    "This is an issue," said Brandon Fradd, a biotechnology
 analyst with Montgomery Securities.  "Even if the virus is
 dead, what if someone got HIV and was somehow infected from
 this thing?  The chances of this happening are extraordinarily
 remote, but not zero."  He notes that a batch of the virus
 might not be properly inactivated.  Mr. Fradd adds, however,
 that the company's main focus has always been to use such a
 vaccine as a therapy for individuals already infected with
 HIV.  
    Scott Putney, a leading AIDS scientist now with Alkermes
 Inc., says that "it's theoretically possible that a problem
 could happen, but it would be a very rare event."  He adds
 that the technology to make such vaccines has been developed
 to the point that "you could assure with great certainty that
 the virus has been inactivated."  Dr. Putney says his real
 reservation with such a killed-virus vaccine is that it
 simply may not work on uninfected patients.
    The Immune Response spokesman stressed that "our focus,
 and 99% of our efforts so far have been dedicated toward a
 treatment for already infected patients."  The San Diego
 company has no product sales as yet, but all of its $4.3
 million in total research revenue for 1991 were for clinical
 trials and work on infected patients.
    In late over-the-counter trading, Immune Response shares
 were quoted at $28.50, up 25 cents a share.
    In addition to disclosing the delay in the clinical
 trials, Immune Response yesterday announced that it has
 completed a study showing that a certain method or "surrogate
 marker" can successfully identify the amount of the virus
 present in human blood, and that higher virus quantities
 correlate with different stages of AIDS.  The results of the
 study, published in the current issue of AIDS Research and
 Human Retroviruses, give the company a more reliable
 benchmark to measure progress or lack of such in patients
 undergoing clinical trials of Immune Response's HIV vaccine.
    Last November, a Food and Drug Administration advisory
 panel said that one such surrogate marker couldn't be used as
 the sole indicator for regulatory approval and that clinical
 indicators, which typically involve longer trial periods,
 would remain an important factor.  But the Immune Response
 spokesman said the company hoped that its marker, combined
 with others being studied, would prompt the FDA to reconsider
 the issue.

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