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Vertex Pharmaceuticals Incorporated Message Board

  • aliensinla aliensinla Jun 7, 1998 3:21 AM Flag

    June 5 98 *Press Release*

    June 5, 1998 9:37 AM EDT

    CAMBRIDGE,
    Mass., June 5 /PRNewswire/ -- The investigational
    HIV
    protease inhibitor amprenavir achieves
    significant concentrations
    in the cerebrospinal fluid
    (CSF), suggesting that the drug crosses
    the
    blood-brain barrier and may provide potent antiviral
    activity
    in the brain, a key viral reservoir. Interim
    32-week data released
    today showed that 8 of 9
    patients achieved viral load levels in
    the CSF below
    the limits of detection for the assay used
    (<400
    copies/mL) in two different early clinical trials
    involving
    amprenavir (formerly known as VX-478 or 141W94)
    in combination
    with Retrovir(R) (AZT) and
    Epivir(R) (3TC). Researchers presented
    the data at the
    8th Annual Neuroscience of HIV conference held

    this week in Chicago, Illinois.

    "The
    development of potent antiviral regimens capable of

    suppressing HIV replication in all viral reservoirs,
    including the
    CSF and other central nervous system
    tissues, is an important
    consideration for the
    management of HIV disease," commented Joshua
    Boger
    Ph.D., Vertex Chairman, President and CEO. "We are

    encouraged by the observed antiviral effect in the CSF with
    this
    three-drug combination at 32 weeks in patients.
    These research
    findings complement a comprehensive
    data package being compiled
    now for regulatory
    submissions for amprenavir worldwide."

    "Amprenavir
    was designed as a chemically compact molecule and
    it
    is this distinguishing characteristic that may
    allow the compound
    to achieve more efficient
    penetration of otherwise protected
    compartments such as
    the central nervous system," added Dr. Vicki

    Sato, Senior Vice President of Research and Development
    and Chief
    Scientific Officer of Vertex.
    "Preliminary data emerging from
    several clinical trials
    suggests that amprenavir-containing drug
    regimens can
    achieve potent and durable suppression of HIV in

    plasma, and are now also confirming amprenavir's
    penetration and
    activity in other viral reservoirs such
    as the CSF. There is more
    work to be done to
    fully characterize this activity, but we are

    pleased by these early results."

    Researchers
    analyzed CSF and plasma samples from 9 volunteers

    participating in either one of two clinical trials. In the
    Phase
    II clinical trial which is ongoing, patients
    received escalating
    doses of amprenavir from 900 mg
    twice daily to 1200 mg twice daily
    in combination
    with Retrovir(R) and Epivir(R). In this study,
    100%
    of patients (4 out of 4) achieved viral load
    suppression in the
    CSF to below the limit of detection
    (<400 copies/mL) at 32 weeks.

 
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