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Maximine Update from AASLD

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  • claudine intexas
    NATAP www.natap.org ... This new HCV treatment in development was updated at AASLD. It will be studied in combination with Pegasys. It s limited by the fact
    Message 1 of 1 , Dec 9, 2000
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      NATAP
      www.natap.org
      ----------------

      This new HCV treatment in development was updated at
      AASLD. It will be
      studied in combination with Pegasys. It's limited by
      the fact that it
      is
      administered by subcutaneous injection.

      Maximine

      Maximine is an immune based therapy with application
      for certain
      cancers. It
      is supposed to inhibit oxidative stress which can
      cause irreversible
      damage
      to lymphocytes which are essential for viral killing.
      Maxim Pharma
      reported
      48 week results of a 72 week study on 129
      treatment-na�ve HCV-infected
      individuals receiving interferon+Maxima. Maxima was
      given at various
      dosing
      regimens and is
      administered by subcutaneous injections. This was an
      open-label
      multicenter,
      international study. At baseline mean age was young
      (30), Viral load
      was high
      at 6.7 million, and 53% with >2 million copies/ml. 47%
      had genotype 1,
      and
      about 49% had genotype 2. Patients were randomized to
      1 of 4 dosing
      regimens
      of Maxima.

      A limitation of this study is that all patients
      received Maximine and
      IFN so
      its difficult to tell how much benefit Maximine is
      giving. Another
      limit is
      viral response is defined as <1000 copies/ml. In
      brief, after 48 weeks-

      --58% of all patients (57-69% across all 4 dose
      arms) had
      virologic
      response AND virologic response is defined as >1000
      copies/ml
      --58% with genotype 1b (range 36-88%) had viral
      response
      --70% with genotypes 2/3 (58-80%) had viral
      response
      --48% with high viral load (33-57%) had viral
      response
      --Drug administration resulted in mild
      transient side effects.
      It
      induced short lasting flush in most patients and a
      short lasting
      --headache, hypotension, and lachycardia in
      some patients. They
      said
      overall it was well tolerated. 5% discontinued study
      by week 48.

      Another unusual aspect of results is that genotype 1
      patients did
      better than
      genotype 2/3. They reported drug has an acceptable
      safety profile.
      They
      reported preliminary 12 week data from small ongoing
      study of
      IFN+Maxima+RBV
      who did not respond to previous therapy (nonresponders
      & relapsers).
      15/18
      are genotype 1. After 8 weeks patients can increase
      IFN dose ftom 3 MIU
      three
      times per week to 3-6 MIU daily. Maxima dose was 1 mg
      bid, tiw
      subcutaneous
      injection with option to escalate to 1 mg bid, once
      weekly. After 12
      weeks,
      4/13 were serum HCV RNA negative. Obviously too soon
      to tell anything.
      And
      8/13 had 2 or more log decrease in viral load. 5/18
      discontinued
      therapy.
      There were no unexpected and/or irreversible adverse
      events.

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