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