Navigation Links
Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders
Date:5/21/2008

TAMPA, Fla., May 21 /PRNewswire/ -- Romark Laboratories, L.C., a privately-owned biopharmaceutical company, today announced the completion of enrollment into its Phase II clinical trial to evaluate the safety and efficacy of nitazoxanide in combination with standard of care therapy in U.S. patients with chronic hepatitis C genotype 1 who have previously failed to respond to the standard of care therapy (peginterferon and ribavirin). The company expects to announce interim data results at a medical meeting this fall. Romark recently announced the initiation of a Phase II trial of nitazoxanide in treatment-naive patients with chronic hepatitis C infected with genotype 1 (STEALTH C-3).

"Completing enrollment in this Phase II trial is a significant achievement for Romark and an important step in the clinical development of nitazoxanide," stated Marc Ayers, Chief Executive Officer of Romark. "We believe nitazoxanide represents a promising approach to the treatment of hepatitis C for the millions of people who are infected with this serious liver disease."

The study, called STEALTH C-2 (Studies to Evaluate Alinia for Treatment of Hepatitis C), is the second in a series of clinical trials designed to evaluate the safety and efficacy of nitazoxanide tablets in combination with Pegasys(R) (peginterferon alfa-2a) or peginterferon and Copegus(R) (ribavirin) in patients with chronic hepatitis C. STEALTH C-2 is a randomized, double-blind, placebo-controlled trial conducted in the United States in 60 patients with chronic hepatitis C genotype 1, who are non-responders to prior peginterferon and ribavirin therapy. The study is designed to evaluate the effectiveness and safety of nitazoxanide administered 500 mg twice daily for four weeks followed by nitazoxanide plus Pegasys plus Copegus combination therapy for 48 weeks, compared to placebo for four weeks followed by placebo plus Pegasys plus Copegus combination therapy for 48 weeks. Pegasys and Copegus are being provided under a collaborative agreement between Romark and F. Hoffmann-La Roche Ltd.

Romark recently announced enrollment for its STEALTH C-3 clinical trial, a Phase II randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of nitazoxanide in combination with peginterferon alfa-2a and ribavirin in treatment nave patients with chronic hepatitis C infected with genotype 1. Enrollment for the STEALTH C-3 study began in April 2008 and the trial will enroll 60 patients at 15 centers in the U.S.

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.

About Nitazoxanide

Nitazoxanide belongs to a new class of small molecule kinase activators called the thiazolides. Like interferons, thiazolides modulate cell signaling pathways involved in the host cell's innate defense against viruses. Thiazolides can be administered orally and are not associated with side effects commonly associated with use of interferon. Nitazoxanide was discovered by Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark, and was initially developed by Romark and approved for marketing in the United States as a treatment for cryptosporidiosis. Recent laboratory studies have shown that nitazoxanide does not induce resistance mediated by mutations in the viral genome.

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 may occur. 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 (http://www.romark.com), 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.

Media Contact:

BMC Communications Group, LLC

Marissa Nelson

212-477-9007 x21


'/>"/>
SOURCE Romark Laboratories, L.C.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at EASL 2008
2. Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1
3. Romark Laboratories Raises $18 Million in Institutional Financing
4. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
5. Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results
6. Northfield Laboratories Inc. Presentation at FDA/NIH Workshop on Hemoglobin-Based Oxygen Carriers
7. Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies
8. Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
9. Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia
10. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
11. Ikaria Completes Dosing of Phase 1a Clinical Study for IK-1001 (Sodium Sulfide) for Injection
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... June 24, 2016 Research and Markets ... for Companion Diagnostic Tests" report to their offering. ... Companion Diagnostics The World Market for Companion ... medicine diagnostics. Market analysis in the report includes the following: ... (In Vitro Diagnostic Kits) by Region (N. America, EU, ROW), ...
(Date:6/24/2016)... KNOXVILLE, Tenn. , June 24, 2016 /PRNewswire/ ... market providing less invasive and more durable cerebrospinal ... million in funding.  The Series-A funding is led ... the Lighthouse Fund, and other private investors.  Arkis, ... less-invasive neurosurgical instrumentation and the market release of ...
(Date:6/23/2016)... Research and Markets has announced the addition ... Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, Binder, ... Forecast to 2021" report to their offering. ... excipients market is projected to reach USD 8.1 Billion ... forecast period 2016 to 2021. The ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... ... 2016 , ... Those who have experienced traumatic events may suffer from a ... such as drug or alcohol abuse, as a coping mechanism. To avoid this pain ... following a traumatic event. , Trauma sufferers tend to feel a range of emotions, ...
(Date:6/24/2016)... Dallas, Texas (PRWEB) , ... June 24, 2016 ... ... 12th International Conference and Scientific Sessions in Dallas that it will receive two ... Announcement of the grants came as PHA marked its 25th anniversary by recognizing ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
Breaking Medicine News(10 mins):