Phase II Study Shows that Nitazoxanide Significantly Improves Response to Standa

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Phase II Study Shows that Nitazoxanide Significantly Improves

Response to Standard of Care in Patients with Chronic Hepatitis C

Fri, 02 Nov 2007 11:05:00 GMT

TAMPA, Fla., Nov. 2 /PRNewswire/ -- Romark Laboratories, a privately-

owned biotechnology company, today announced results of a randomized

phase II clinical trial showing that 79% of interferon-naive patients

with chronic hepatitis C genotype 4 receiving nitazoxanide plus the

standard of care had a sustained virologic response (SVR), or

undetectable level of virus, 12 weeks following treatment, compared

to 43% of patients receiving the standard of care without

nitazoxanide. The patients treated with nitazoxanide also experienced

no relapse and no more side effects than patients who received the

standard of care. Interim results from this Phase II clinical trial

will be presented on Tuesday November 6 in an oral presentation at

the 58th Annual Meeting of the American Association for the Study of

Liver Diseases (AASLD) in Boston.

" Patients treated with nitazoxanide responded earlier and maintained

their responses without relapse after receiving only 36 weeks of

treatment with peginterferon and ribavirin, " said Dr. Emmet B.

Keeffe, Chief of Hepatology at Stanford University School of

Medicine. " These data suggest the emergence of a new therapeutic

approach for treating hepatitis C. While more study is needed to

confirm these results in a broader population of patients,

nitazoxanide appears to increase the potency of interferon without

increasing toxicity or inducing resistance. "

Study Details

This Phase II randomized, controlled trial was conducted at two

centers in Egypt and is part of the company's STEALTH C (Studies to

Evaluate Alinia for Treatment of Hepatitis C) clinical development

program, which is designed to evaluate the safety and efficacy of

nitazoxanide tablets in combination with peginterferon or

peginterferon and ribavirin (standard of care) in patients with

chronic hepatitis C.

In the trial, 96 treatment-naive patients with chronic hepatitis C

genotype 4 were randomized into three groups to receive either 48

weeks of standard of care treatment (n=40), 12 weeks of nitazoxanide

followed by 36 weeks of nitazoxanide plus peginterferon (a dual

regimen, n=28), or 12 weeks of nitazoxanide followed by 36 weeks of

nitazoxanide plus standard of care treatment (a triple regimen,

n=28). An additional 24 interferon-experienced patients were

randomized to receive 12 weeks of nitazoxanide followed by either the

dual regimen (n=12) or the triple regimen (n=12) for 36 weeks.

Patients received 180 microgram injections of pegylated interferon

(Pegasys®) once per week; nitazoxanide was administered as one 500

mg tablet twice daily; and ribavirin was administered as 1,000 or

1,200 mg daily according to weight.

Results

At 12 weeks following the end of treatment, naive patients who

received a triple regimen that included standard of care and

nitazoxanide showed a significantly higher SVR (HCV RNA <10 IU/mL,

Abbott m2000) than the group receiving the standard of care regimen

(79% vs. 43%, respectively) (p=0.006). The data also suggest a

potential for eliminating or reducing the role of ribavirin in

treating hepatitis C. Patients treated with a dual regimen of

nitazoxanide and peginterferon showed an SVR at week 12 following the

end of treatment that was not inferior to standard of care (68% vs.

43%, respectively) (+25%; 95% CI: -1%, +47%). Of 24 treatment-

experienced patients, the triple regimen (n=12) resulted in an SVR of

25% at week 12 post- treatment, and the dual regimen group (n=12) had

an SVR of 8%.

" Results from this trial validate a new approach to treating HCV that

focuses on the interaction between the virus and the cell, " said Jean-

Francois Rossignol, M.D., Director of the Romark Institute for

Medical Research. " With confirmation provided by this data we are

aggressively pursuing development of nitazoxanide and related drugs

to treat chronic hepatitis C and other viral diseases. "

Nitazoxanide is the first of a new class of small molecule drugs

called thiazolides that inhibit replication of a broad range of

viruses. The drug was discovered by Dr. Rossignol and was initially

developed by Romark and approved for marketing in the United States

as the first treatment of cryptosporidiosis. Serendipitously, the

development of nitazoxanide for treating cryptosporidiosis led to the

discovery of its antiviral properties and ultimately to the discovery

of a promising new class of antiviral drugs.

Romark is currently conducting a U.S. Phase II trial with

nitazoxanide plus standard of care in patients with hepatitis C

genotype 1 who were previously treated with interferon. The Company

also plans to initiate a Phase II trial in treatment naive patients

early in 2008.

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. Chronic HCV infection may cause liver cirrhosis or

hepatocellular carcinoma. An estimated 3.2 million people in the U.S.

are chronically infected by hepatitis C virus. Globally, an estimated

170 million people are chronically infected, with three to four

million persons newly infected each year, according to the World

Health Organization.

About Romark Laboratories

Romark Laboratories, L.C. (http://www.romark.com/) is a privately-

owned biotechnology company committed to the discovery and

development of innovative new small molecules for treating infectious

diseases, cancers, and autoimmune diseases.

About Alinia

Alinia (nitazoxanide) is indicated in the United States for treatment

of diarrhea caused by Cryptosporidium parvum or Giardia lamblia in

patients 1 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. Alinia is an investigational new drug

in the United States for treating chronic hepatitis C.

Romark Laboratories