Repligen Corp said it intendsto file an investigational new drug application to the Food and
Drug Administration seeking permission to test its AIDS vaccine
in humans by the early summer.
    Repligen said the human tests could begin by the end of the
year.
    "We are sufficiently encouraged and impressed by the work
to date to go ahead with a clinical trial," said Michael Egan,
manager of business development for Repligen, a biotechnology
company.
    Repligen's Egan said the vaccine contains a subfragment of
the protein coat of the AIDS virus. In animal tests, which
included primates, Egan said the vaccine provoked neutralizing
antibodies to the AIDS virus and broader cellular immunity.
    Egan said the approach Repligen is using to deliver its
vaccine, using standard vaccine methods, may be safer than
vaccines using a live smallpox virus to carry proteins found on
the surface coat of the AIDS virus.
    Yesterday, Bristol-Myers Co &lt;BMY> said it would seek
regulatory permission to test its AIDS vaccine, which uses a
smallpox virus, in humans by the end of the month.
    Repligen's AIDS vaccine is a collaborative effort of the
company, Centocor Inc &lt;CNTO>, Duke University Medical School
and the National Cancer Insitutes. The research teams are
directed by John Ghrayeb of Centocor, Scott Putney of Repligen,
Dani Bolognesi at Duke and Robert Gallo and Flossie Wong-Staal
at the National Cancer Institute.
    Although there are several AIDS vaccine candidates, experts
believe that development of a safe and effective vaccine is a
long ways away. Moreover, seeking approval to test a vaccine is
only the first step in a long process of verifying if the
vaccine actually will prevent infection.

 Reuter
