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FW: NATAP: nitazoxanide-New Treatment for Chronic Hepatitis C

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  • alleypat
    This is interesting because it says it has no big sides and seems to work for geno 4 within 24 weeks. Alley I m blonde, therefore I m lost Alley (Patricia)
    Message 1 of 1 , Jan 10, 2006
      This is interesting because it "says' it has no big sides and seems to work
      for geno 4 within 24 weeks.


      I'm blonde, therefore I'm lost
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      Add me to your address book... Want a signature like this?

      -----Original Message-----
      From: nataphcv-bounces@... [mailto:nataphcv-bounces@...]On
      Behalf Of nataphcv@...
      Sent: Tuesday, January 10, 2006 1:50 PM
      To: nataphcv@...; nataphcvhiv@...; natapdoctors@...;
      Subject: NATAP: nitazoxanide-New Treatment for Chronic Hepatitis C

      Romark to Develop Alinia(R) (nitazoxanide) as New Treatment for Chronic
      Hepatitis C

      Press Release Source: Romark Laboratories

      Tuesday January 10, 10:15 am ET

      24-Week Data from International Phase II Study Demonstrates Virologic
      Response to Oral Monotherapy

      TAMPA, Fla., Jan. 10 /PRNewswire/ -- Romark Laboratories announced that it
      is initiating U.S. clinical development of Alinia. (nitazoxanide) tablets
      for treating chronic hepatitis C.

      The company has filed an Investigational New Drug (IND) Application with the
      United States Food & Drug Administration and plans to seek Fast-Track
      designation for treating chronic hepatitis C. The initial clinical study in
      the United States will evaluate Alinia administered orally 500 mg twice
      daily for 24 weeks as monotherapy compared to a placebo in patients who have
      previously failed pegylated interferon and ribavirin combination therapy.

      An estimated 3.4 million people in the U.S. are infected by hepatitis C
      virus. Globally, an estimated 170 million people are chronically infected,
      with three to four million new cases reported each year, according to the
      World Health Organization. Some patients can be successfully treated with
      interferon-based treatment regimens, but safety and tolerability issues and
      suboptimal response rates leave a large number of patients without an
      effective treatment option.

      Alinia (nitazoxanide) is the first of a new class of drugs called the
      thiazolides. Members of this class of drugs are small molecules that
      suppress replication of certain viruses by selectively inhibiting synthesis
      of virus structural proteins. Studies have shown that nitazoxanide and its
      circulating metabolite, tizoxanide, suppress replication of hepatitis B and
      C viruses in cell culture at low (nanomolar to low micromolar)

      A phase II, double-blind, placebo-controlled clinical trial of Alinia as
      oral monotherapy in patients with chronic hepatitis C was initiated in early
      2005 at the Romark Digestive Disease Research Center in Egypt. The patients
      were infected with HCV genotype 4. Approximately 10% of the patients had
      previously failed pegylated interferon and ribavirin combination therapy.

      An interim analysis of the first 20 patients enrolled in the study showed
      that 50% of patients receiving Alinia administered orally as one 500 mg
      tablet twice daily with food had undetectable HCV RNA in serum at the end of
      24 weeks of treatment compared to none of the patients in the placebo group
      (P=0.03). Importantly, the drug has been well tolerated by the patients with
      no significant side effects. The study is continuing with patients being
      followed up to evaluate the durability of response off-treatment.

      Ongoing international studies are also evaluating Alinia in combination with
      pegylated interferon.

      Results of preclinical and clinical studies are expected to be presented in
      medical journals and congresses later this year.

      "This is an exciting development program," said Jean-Francois Rossignol,
      M.D., Ph.D., chairman and chief science officer of Romark and the inventor
      of nitazoxanide and other thiazolides. "There is a tremendous need for a new
      treatment of chronic hepatitis C. Our results to date are encouraging, and
      we look forward to expanding our knowledge with the launch of clinical
      trials in the U.S."

      "It is important that the mechanism of action of this class of drugs against
      hepatitis C virus is novel and differs from that of interferon and other
      traditional antiviral drugs," added Rossignol. "Further study will be needed
      to fully understand the implications of this unique mechanism of action, but
      potential benefits may include synergistic effects with other antiviral
      drugs and reduced risk of developing drug-resistant viruses."

      Alinia is approved for marketing in the United States for treatment of
      diarrhea caused by Cryptosporidium parvum and Giardia lamblia and is under
      development for treating Clostridium difficile-associated disease and
      Crohn's disease, in addition to chronic hepatitis C.

      Nitazoxanide was first developed because of its unique broad-spectrum
      activity against intestinal parasites and anaerobic bacteria and its
      favorable safety profile compared to metronidazole. It is the first drug
      proven effective in treating intestinal disease caused by the coccidian
      protozoan, Cryptosporidium. A recently completed study demonstrated
      non-inferiority of nitazoxanide compared to metronidazole (standard of care)
      in treating hospitalized patients with Clostridium difficile-associated

      The antiviral activity of nitazoxanide was discovered as part of a
      development program for treating Cryptosporidium infection in patients with
      human immunodeficiency virus (HIV). The development program for AIDS-related
      cryptosporidiosis also provided safety data related to extended durations of
      treatment with nitazoxanide.

      Based upon in vitro studies demonstrating activity of nitazoxanide and its
      active circulating metabolite, tizoxanide, in inhibiting replication of
      hepatitis B and C viruses, Romark initiated a series of phase II clinical
      trials at its Digestive Disease Research Center in Egypt early in 2005 to
      evaluate the effectiveness of oral nitazoxanide as monotherapy in treating
      chronic hepatitis B and C. The research center in Egypt had previously
      conducted clinical trials required for obtaining FDA approval of Alinia for
      treating diarrhea caused by Cryptosporidium spp. and Giardia lamblia.

      "The development of Alinia as a treatment of chronic hepatitis C is an
      important step for our company," said Marc Ayers, president and chief
      executive officer of Romark. "This development program underscores our
      ongoing commitment to bring innovative new first-in-class and best-in-class
      pharmaceutical products to the marketplace."

      About Hepatitis C

      Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), a
      virus spread through direct contact with the blood of infected people. While
      many people with hepatitis C do not experience symptoms, others experience
      jaundice, abdominal pain, fatigue and fever. Chronic HCV infection may cause
      liver cirrhosis or hepatocellular carcinoma.

      About Romark Laboratories

      Romark Laboratories, L.C. ( http://www.romark.com ) is a pharmaceutical
      company dedicated to the discovery and development of innovative new
      first-in- class and best-in-class pharmaceutical products. Headquartered in
      Tampa, Florida, Romark conducts research and commercializes its products in
      the United States and in Latin America.

      About Alinia

      Alinia (nitazoxanide) is indicated in the United States for treatment of
      diarrhea caused by Cryptosporidium parvum or Giardia lamblia in patients one
      year of age and older. Alinia has not been shown to be superior to placebo
      for the treatment of diarrhea caused by Cryptosporidium parvum in
      HIV-infected or immunodeficient patients. The most common adverse events
      reported by patients receiving Alinia have been abdominal pain, diarrhea,
      headache and nausea. In controlled trials, the frequency of these events has
      been similar to patients receiving a placebo. Worldwide, more than 10
      million people have been treated with nitazoxanide.

      Alinia is under development in the United States for treatment of a range of
      digestive diseases including Clostridium difficile-associated diarrhea,
      Crohn's disease and chronic hepatitis C. It is considered an investigational
      new drug for each of these indications. Alinia has not been approved by the
      FDA as safe or effective in treating Clostridium difficile-associated
      disease, Crohn's disease or chronic hepatitis B or C.


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