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Re: Clinical Trials in Pennsylvania

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  • caban cirene
    Hi everyone Clinical trials of PEG (!) for non-responders in PA CONTACT Dr. Bross at the Geisinger center in Danville, (570) 271-6439. OR Additional
    Message 1 of 1 , Oct 3, 2000
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      Hi everyone

      Clinical trials of PEG (!) for non-responders in PA

      CONTACT

      Dr. Bross at the Geisinger center in Danville, (570)
      271-6439.

      OR

      Additional information on hepatitis C can be found on
      the Centers for Disease Control's Web site:
      http://www.cdc.gov Type "hepatitis C" in the
      search box.

      cirene

      --- claudine intexas <claudineintexas@...>
      wrote:
      > Business Wire
      > April 12, 2000
      >
      > Maxim Reports 69% Complete Response at 24 Weeks in
      > Phase II Trial of
      > Maxamine and Interferon-Alpha in the Treatment of
      > Hepatitis C.
      >
      > Business Editors/Health and Medical Writers
      >
      > SAN DIEGO--(BW HealthWire)--April 12, 2000
      >
      > Maxim Pharmaceuticals (AMEX:MMP)(SSE:MAXM) announced
      > today 24-week results
      > from its Phase II dose-ranging study of Maxamine(R)
      > (histamine
      > dihydrochloride) in combination with
      > interferon-alpha
      > (IFN-alpha) in the
      > treatment of naive, chronically infected hepatitis C
      > patients.
      >
      > After 24 weeks of therapy, the combination of the
      > optimal dosing regimen of
      > Maxamine and IFN-alpha achieved a complete viral
      > response in 69 percent of
      > all patients, compared to the 29 percent or less
      > response that is commonly
      > observed in patients with similar profiles treated
      > with IFN-alpha alone. The
      > results will be presented today at the 10th
      > International Symposium on Viral
      > Hepatitis and Liver Disease sponsored by the U.S.
      > Center for Disease Control
      > and Prevention in Atlanta by the principal
      > investigator in the study, Yoav
      > Lurie M.D., Liver Clinic Director, Kaplan Medical
      > Center, Israel.
      >
      > "These are very promising 24-week results," said Dr.
      > Lurie. "These results
      > are even more impressive due to the high viral loads
      > of the patients
      > participating in this study, coupled with the
      > significant percentage of
      > patients with the genotype-1 virus, both of which
      > are
      > factors that would
      > typically lead to a substantially lower response
      > with
      > either IFN-alpha alone
      > or other existing treatments. I look forward to
      > advancing the testing of
      > Maxamine in hepatitis C, particularly in combination
      > with some of the
      > emerging therapies such as pegylated interferon and
      > ribavirin."
      >
      > Study Design
      >
      > The trial is designed to evaluate the combination of
      > Maxamine and IFN-alpha
      > in the treatment of chronic hepatitis C patients who
      > had not been previously
      > treated with IFN-alpha. The primary goals of this
      > study are to determine the
      > most appropriate dosing regimen for Maxamine in the
      > treatment of naive
      > chronic hepatitis C patients, and to provide further
      > evidence that Maxamine
      > may benefit cytokines such as IFN-alpha in the
      > treatment of this viral
      > infection. The 129-patient trial is based in the
      > United Kingdom, Belgium,
      > Israel and Russia.
      >
      > Patients were randomly assigned to one of four
      > treatment groups, and each
      > patient received Maxamine, in one of four dosing
      > regimens, plus IFN-alpha at
      > the standard dose of 3miu three times per week. The
      > study will evaluate the
      > efficacy and safety of each of the four dosing
      > regimens. Under the two
      > lower-dose regimens, patients administer one dose of
      > Maxamine each treatment
      > day, and receive a total of either 3 mg or 5 mg of
      > the
      > drug per week of
      > therapy. Under the two higher-dose regimens,
      > patients
      > administer two doses
      > of Maxamine each treatment day, and receive a total
      > of
      > either 6 mg or 10 mg
      > of the drug per week of therapy.
      >
      > The primary measures of efficacy in the study are a
      > reduction in viral load
      > and a normalization of liver function. A complete
      > viral response is defined
      > by virus levels that are below the limit of
      > detection
      > using a validated
      > PCR-RNA technique. A complete biochemical response
      > is
      > defined as
      > normalization of liver enzyme levels, measured by
      > the
      > liver enzyme ALT, a
      > standard measure of liver function. Patients who
      > responded during the first
      > 12 weeks of treatment will continue treatment
      > through
      > 48 weeks, with
      > additional evaluations at 24, 48 and 72 weeks.
      >
      > 24-Week Study Results
      >
      > After 24 weeks of therapy, the combination of the
      > optimal dosing regimen of
      > Maxamine and interferon achieved a complete
      > biochemical and viral response
      > in 69 percent of all patients. Published reports
      > suggest that 29 percent or
      > less of patients with similar profiles achieve a
      > complete biochemical and
      > viral response when treated with IFN-alpha therapy
      > alone.
      >
      > A dose response was observed in the study, and 69
      > percent of the patients
      > treated with either of the two higher-dose,
      > twice-per-day regimens achieved
      > complete viral responses after 24 weeks of
      > treatment,
      > while 60 percent of
      > the patients treated with either of the two
      > lower-dose, once-per-day
      > regimens achieved a complete viral response. The
      > complete viral response for
      > all patients in the study combined was 64%.
      >
      > The results also suggest that Maxamine provided a
      > benefit even in the
      > patients expected to have a poor prognosis. Certain
      > factors can influence
      > the response of a hepatitis C patient to therapy,
      > including the patient's
      > viral load and the genotype of the virus with which
      > the patient is infected.
      > Of the variations, or genotypes, of hepatitis C,
      > genotype-1 is the most
      > common type comprising approximately 70% of the
      > patients in the United
      > States and Asia, and 50% in Europe. Patients
      > infected
      > with genotype-1
      > typically have the poorest response to treatment. In
      > the Maxim study, 50% of
      > the patients were infected with the genotype-1
      > variant
      > of the virus. Despite
      > the poor prognosis for successful treatment, 79% of
      > the patients with
      > genotype-1 virus treated with either of the
      > twice-per-day regimens of
      > Maxamine for 24 weeks achieved a complete viral
      > response.
      >
      > Patients with high viral levels, viral levels
      > greater
      > than two million
      > copies per milliliter of blood, also typically have
      > a
      > poor response to
      > treatment. In the ongoing Phase II study, the mean
      > viral load of the
      > patients entering the trial was 6.7 million copies
      > per
      > milliliter of blood,
      > more than three times higher than the 2.0 million
      > copies normally considered
      > to be difficult to treat. However, 64% of the
      > patients
      > with more than 2
      > million copies per milliliter of blood treated with
      > either of the
      > twice-per-day regimens of Maxamine achieved a
      > complete
      > viral response.
      >
      > Patients in the study were able to treat themselves
      > at
      > home with the
      > Maxamine and IFN-alpha combination therapy. The
      > interim 24-week results
      > suggest that patient compliance and the safety
      > profile
      > of the therapy were
      > consistent with the positive results shown in other
      >
      === message truncated ===


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