Navigation Links
Phase II Study Shows that Nitazoxanide Significantly Improves Response to Standard of Care in Patients with Chronic Hepatitis C

Data to be Presented at AASLD Meeting

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(R)) 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.


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. ( 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.

SOURCE Romark Laboratories
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. FDA approves Phase 0 trial which tests experimental drugs on humans
2. SARS-Free Taiwan to Mark End Phase of Global Fight
3. S. Africa AIDS in death phase
4. Spray on contraceptive clears Phase I trial
5. Phase 3 trials of two multi-kinase inhibitors against cancer
6. Antigenics Pharmaceuticals plans for Phase III trial of its Melanoma vaccine
7. Phase II trails of new HIV vaccine to be held in South Africa
8. Phase 1 Drug Trials on Humans to Be Made Public
9. Jalgaon: Third Phase Of Culling Operations Begin
10. Lupin Gets DCGI Nod For Phase II Clinical Trials On Desoside-P
11. Cadila to Commence Phase I Clinical Trials On ZYH2
Post Your Comments:
(Date:12/1/2015)... ... 2015 , ... World Patent Marketing , a vertically integrated manufacturer ... for easier packing and organizing of items into one big, portable jar. , The ... CEO and Creative Director of World Patent Marketing and Desa Industries Inc . ...
(Date:12/1/2015)... ... December 02, 2015 , ... ClinicoEconomics ... association with initiation of treatment for osteoporosis ”. , As corresponding author Dr ... in patients diagnosed with osteoporosis. Based on a large US managed care database, ...
(Date:12/1/2015)... ... December 01, 2015 , ... Integrated Rental Services ... Jordan Industries International, LLC (“JII”). , With support from JII, Integrated Rental is ... to hospitals, surgery centers, clinics, research labs and medical facilities across the United ...
(Date:12/1/2015)... CA (PRWEB) , ... December 01, 2015 , ... According ... of obesity groups has filed a discrimination claim against the U.S. Department of Health ... in their Affordable Care Act (ACA) plans are breaking the clause in the law ...
(Date:12/1/2015)... ... 2015 , ... Baptist Medical Center Jacksonville has implanted the ... hospital in the region providing what is known as the world’s smallest pacemaker. ... revealed recently at a medical conference and published in The New England Journal ...
Breaking Medicine News(10 mins):
(Date:12/1/2015)... , BANGALORE, India and ... N.V. (NASDAQ, TASE: MYL) today announced that it expects ... and for developing country markets funded by international donors, ... mg + Efavirenz 400 mg) for $99 per patient, ... Initiative (CHAI) to develop TLE400. The significantly reduced price ...
(Date:12/1/2015)... CARLSBAD, Calif. , Dec. 1, 2015 ... medicine products and services, announced today that it has ... care services organization. Members served by Novation will have ... therapy devices, sports bracing products and soft goods dedicated ... --> The aging U.S. population, rising ...
(Date:12/1/2015)... 2015 Building on its 25-year legacy ... (NYSE: JNJ ) today announced four new ... significantly reduce the burden of HIV incidence, especially ... of new HIV infections among adolescents in sub-Saharan ... these new initiatives include collaborations with the U.S. ...
Breaking Medicine Technology: