Loading ...
Sorry, an error occurred while loading the content.

Maxim Reports 69% Complete Response at 24 Weeks in Phase II Trial of Maxamine and Interferon-Alpha in the Treatment of Hepatitis C.

Expand Messages
  • claudine intexas
    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
    Message 1 of 1 , Oct 2, 2000
    • 0 Attachment
      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
      ongoing and completed
      Maxamine trials.

      "We have not seen published reports of 24-week
      end-of-treatment data better
      than those obtained in our study with Maxamine," said
      Kurt R. Gehlsen,
      Ph.D., Maxim's Vice President, Development and Chief
      Technical Officer. "The
      results are also impressive due to the high percentage
      of patients in this
      study that would normally be considered to have a poor
      prognosis due to a
      high viral load and/or an infection with the
      genotype-1 variant of the
      virus. The majority of hepatitis C patients in the
      United States and Asia
      are infected with the genotype-1 virus, and existing
      therapies are largely
      ineffective in this patient population."


      "These results are consistent with the positive
      results we have seen when
      using Maxamine in other clinical studies for
      indications such as malignant
      melanoma, acute myelogenous leukemia and renal cell
      carcinoma," stated Larry
      G. Stambaugh, Maxim's Chairman and CEO. "We believe
      the discovery underlying
      Maxamine represents a mechanism for overcoming immune
      suppression that may
      have universal application to a number of cancers and
      infectious diseases."

      Hepatitis C

      Hepatitis C is more easily transmitted than HIV and is
      now the leading
      blood-borne infection in the United States. The U.S.
      Center for Disease
      Control and Prevention estimates that over 4.5 million
      Americans are
      infected with the hepatitis C virus. The World Health
      Organization and other
      sources estimate that more than 200 million people are
      infected worldwide.

      Hepatitis is a disease characterized by inflammation
      of the liver and, in
      many cases, permanent cirrhosis (scarring) of the
      liver tissues and
      mortality. The progress of disease from infection to
      significant liver
      damage can take 20 years or more. Some experts
      estimate that without
      substantial improvements in treatment, deaths from
      hepatitis C will surpass
      those from HIV. Hepatitis C is the leading cause of
      liver cancer and the
      primary reason for liver transplantation in many
      countries. The majority of
      patients do not effectively respond to existing
      therapies or to therapies
      known by us to be under development.

      The standard treatment for hepatitis C is IFN-alpha,
      an immunotherapeutic
      agent often given in combination with the anti-viral
      drug ribavirin. The
      majority of patients do not attain a sustained
      response with current
      therapies.

      Maxamine Overview

      Treatment with Maxamine is based upon the discovery of
      a universal mechanism
      that suppresses the capacity of the immune system to
      detect and destroy
      tumor cells or virally infected cells in many patients
      with cancer and
      chronic infectious diseases. Maxamine is designed to
      reverse this immune
      suppression, thereby enhancing the effectiveness of
      immunotherapy, a class
      of therapies that employ the body's immune system to
      fight cancer and
      certain infectious diseases. Maxamine protects
      critical immune cells and is
      administered in combination with cytokines such as
      interleukin-2 and
      IFN-alpha, a class of proteins that stimulate these
      same immune cells. More
      than 1,000 patients have been treated in the Company's
      completed and ongoing
      clinical trials in advanced malignant melanoma, acute
      myelogenous leukemia,
      hepatitis C and renal cell carcinoma. Clinical trial
      results to date suggest
      that Maxamine Therapy, the administration of Maxamine
      in combination with
      cytokines, is a safe, at-home treatment that may
      improve patient survival.
      Maxamine, however, is an investigational drug and
      safety and efficacy have
      not been established at this time.

      Maxim Pharmaceuticals is developing advanced drugs,
      therapies and vaccines
      for cancer and infectious diseases. The Company's lead
      drug candidate,
      Maxamine, is currently being tested in three Phase III
      cancer clinical
      trials in 12 countries for malignant melanoma and
      acute myelogenous
      leukemia. Maxim expects to file its NDA and report
      results for its U.S.
      Phase III study of Maxamine in the treatment of
      malignant melanoma in the
      summer 2000. Phase II trials of Maxamine are also
      underway for the treatment
      of hepatitis C and advanced renal cell carcinoma. The
      Company is also
      developing MaxDerm(TM), for the treatment of medical
      conditions for which
      topical therapy is appropriate such as oral mucositis,
      herpes, decubitus
      ulcers, shingles, burns and related conditions. The
      Company expects to
      commercialize its technologies through a combination
      of in-house development
      and collaborative agreements with pharmaceutical
      companies.

      This news release contains certain forward-looking
      statements that involve
      risks and uncertainties. Such forward-looking
      statements include statements
      regarding the efficacy and intended utilization of
      Maxamine and the
      Company's clinical trials. Such statements are only
      predictions and the
      Company's actual results may differ materially from
      those anticipated in
      these forward-looking statements. Factors that may
      cause such differences
      include the risk that products that appeared promising
      in early research and
      clinical trials do not demonstrate efficacy in
      larger-scale clinical trials
      and the risk that the Company will not obtain approval
      to market its
      products. These factors and others are more fully
      discussed under "Risk
      Factors" and elsewhere in the Company's periodic and
      other reports as filed
      with the Securities and Exchange Commission.

      Note to Editors: Maxamine(R), Maxamine Therapy(TM),
      MaxDerm(TM), and the
      Maxim logo are trademarks of the Company.

      This release is also available on the Internet at: http://www.maxim.com

      __________________________________________________
      Do You Yahoo!?
      Yahoo! Photos - 35mm Quality Prints, Now Get 15 Free!
      http://photos.yahoo.com/
    Your message has been successfully submitted and would be delivered to recipients shortly.