Navigation Links
Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1

Trial Marks Third Study in Company's STEALTH C Clinical Program to Evaluate

Nitazoxanide in the Treatment of Chronic Hepatitis C

TAMPA, Fla., April 18 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, today announced that it has begun enrolling patients in a U.S. clinical trial to evaluate nitazoxanide for the treatment of chronic hepatitis C. Preliminary data from the study is expected in the second half of 2008.

The study, STEALTH C-3 (Studies to Evaluate Alinia for Treatment of Hepatitis C), is a Phase II randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of nitazoxanide in combination with peginterferon alpha-2a (Pegasys(R), Roche) and ribavirin (Copegus(R), Roche) in treatment naive patients with chronic hepatitis C infected with genotype 1.

The primary objective of STEALTH C-3 is to evaluate sustained virologic response (SVR) with a treatment regimen of 4 weeks of nitazoxanide lead-in therapy followed by 48 weeks of standard of care plus nitazoxanide versus 4 weeks of placebo lead-in followed by 48 weeks of standard of care and placebo. The trial will enroll 60 patients at 15 centers in the U.S.

"Earlier clinical studies in patients with chronic hepatitis C infected with genotype 4 have shown that nitazoxanide improves virologic response rates when used in combination with standard of care," said Dr. Emmet B. Keeffe, Chief Medical Officer of Romark. "This study and our ongoing STEALTH C-2 trial, are designed to evaluate the effect of treatment with nitazoxanide plus standard of care in patients with genotype 1. Future clinical trials will explore new combinations and treatment durations, including current and emerging HCV therapies."

STEALTH C Clinical Development Program

STEALTH C-3 is the latest in a series of clinical trials aimed at gaining a broad understanding of how nitazoxanide may benefit patients with chronic hepatitis C genotype 1 when used in combination with peginterferon and ribavirin. Other studies in the STEALTH C program include the following:

-- STEALTH C-2, a randomized, double-blind, placebo-controlled trial

currently enrolling up to 60 patients in the U.S. with chronic

hepatitis C genotype 1 who have previously failed to respond to the

standard of care with peginterferon and ribavirin. This trial is

designed to evaluate the effectiveness and safety of nitazoxanide

administered 500 mg twice daily for 4 weeks followed by nitazoxanide

plus standard of care for 48 weeks compared to placebo for 4 weeks

followed by standard of care plus placebo for 48 weeks.

-- STEALTH C-1, an international study in 120 treatment-naive and

interferon-experienced patients with chronic hepatitis C genotype 4.

Interim results from the randomized controlled Phase II clinical trial

were presented at the 58th Annual Meeting of the American Association

for the Study of Liver Diseases (AASLD) in Boston, MA and demonstrated

that 79 percent of interferon-naive patients with chronic hepatitis C

genotype 4 receiving nitazoxanide plus the standard of care had a

sustained viral response (SVR) at 12 weeks following treatment,

compared to 43 percent 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. Final study results (SVR-24) will be

presented at the European Association for the Study of the Liver

(EASL) in April 2008.

To learn more about Romark clinical trials currently under way, or to find out if a study is recruiting patients in your area, please visit, or (for the latter, enter the search terms "nitazoxanide hepatitis United States.")

About Hepatitis C

Hepatitis C is a blood-borne infectious disease that is caused by the hepatitis C virus (HCV). It is the most common cause of chronic hepatitis in the U.S. and may eventually lead to cirrhosis, liver cancer and liver failure. The disease is transmitted by contact with HCV-infected blood. A large majority of those infected do not show symptoms, but fatigue, abdominal pain and nausea can be common. The current standard treatment of care, peginterferon and ribavirin, is effective in about half of all patients treated. According to the Centers for Disease Control, HCV affects an estimated 4.1 million Americans.

About Romark Laboratories

Romark Laboratories (, a privately held biopharmaceutical company, has discovered and developed a new class of small molecule antivirals known as thiazolides. The Company is developing nitazoxanide, the first of the thiazolide class, for the treatment of chronic hepatitis C, and is developing other new thiazolides for treating viral diseases including chronic hepatitis B. Alinia(R) (nitazoxanide) is approved by the U.S. Food and Drug Administration and marketed by Romark for the treatment of infections caused by Cryptosporidium or Giardia.

SOURCE Romark Laboratories
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Romark Laboratories Raises $18 Million in Institutional Financing
2. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
3. Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies
4. Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
5. Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia
6. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
7. BrainCells Inc. Initiates Phase 2 Clinical Trial with BCI-540 for Depression with Anxiety
8. Insmed Initiates Clinical Study for Follow-on Biologic Version of Neupogen(R)
9. Schering-Plough Initiates Phase II Study With Vicriviroc in Treatment-Naive HIV-Infected Patients
10. Texas Heart(R) Institute at St. Lukes Episcopal Hospital Initiates First Clinical Trial in the World to Treat a Heart Attack Patient with a Special Stem Cell Type
11. Kosan Initiates Phase 2 Trial of Epothilone KOS-1584 in Non-Small Cell Lung Cancer
Post Your Comments:
(Date:6/24/2016)... -- The Academy of Managed Care Pharmacy (AMCP) today ... allow biopharmaceutical companies to more easily share health care ... coverage decisions, a move that addresses the growing need ... The recommendations address restrictions in the sharing of product ... a prohibition that hinders decision makers from accessing HCEI ...
(Date:6/24/2016)... Research and Markets has announced the addition of the ... to their offering. ... World Market for Companion Diagnostics covers the world market for ... report includes the following: , World IVD ... (N. America, EU, ROW), 2015-2020 , World IVD Companion ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... the appointment of Dr. Edward Futcher ... Non-Executive Director, effective June 23, 2016.Dr. Futcher was ... Nominations and Governance Committees.  As a non-executive member ... independent expertise and strategic counsel to VolitionRx in ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... health professionals, announced today its affiliation with Tennessee Counseling Association. This ... the network of the Tennessee Counseling Association, adding exclusive benefits and promotional offers. ...
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is ... emergency ambulance transport experience for the millions of people who require these medical ... the taxi industry through the use of technology. Now, SmartEMS has put forth ...
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer ... they remain in the eye of the beholder, according to experts who offered insights ... American Journal of Managed Care. For the full issue, click here . , ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer ... through a fitness app. The fitness app plans to fix the two major problems leading ... a one size fits all type program , They don’t eliminate all the ...
Breaking Medicine News(10 mins):