Navigation Links
Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at AASLD 2008
Date:11/3/2008

Findings Include 80% SVR Rate with Nitazoxanide-Based Combination Therapy and New Insights into Mechanism of Action of Nitazoxanide

SAN FRANCISCO, Nov. 3 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, today announced that data from studies of nitazoxanide in chronic hepatitis C virus (HCV) infection are being communicated in three presentations made at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting(R), and the 50th Anniversary Meeting of the International Association for the Study of the Liver (IASL) in San Francisco, October 31 - November 4, 2008.

"These new studies confirm earlier data suggesting synergistic activity between nitazoxanide and peginterferon in genotype 4 patients and provide a first look at sustained virologic response in a limited number of genotype 1 patients," said Jean-Francois Rossignol, M.D., Chief Science Officer of Romark Laboratories and discoverer of nitazoxanide. "These data also provide interesting insights into the mechanism of action of nitazoxanide, including a potential role for its combination with STAT-C drugs, and confirm previous findings related to its safety."

The three presentations include:

-- "Evaluation of a 4 Week Lead-In Phase with Nitazoxanide (NTZ) Prior

to Peginterferon (PEGIFN) Plus NTZ for Treatment of Chronic Hepatitis C:

Final Report," J.F. Rossignol et al., Sunday, November 2, 4:15 PM

PST (Oral Session IASL #87), and Tuesday, November 4, 8:00 AM - 12:30

PM PST (AASLD Presidential Poster #1848)

In this Phase II study, 44 patients (40 with HCV genotype 4; 3 with HCV genotype 1; and 1 with HCV genotype 2) received 4 weeks of nitazoxanide 500 mg twice daily followed by Pegasys(R) (peginterferon alfa-2a) and nitazoxanide for 36 weeks. Data from Romark's STEALTH C-1 trial was used as an historical control. Analysis of data was by intention-to-treat.

Thirty-five of 44 patients (80%) treated with a 4-week lead-in phase of nitazoxanide followed by the addition of peginterferon for 36 weeks experienced a SVR 24 weeks after the end of treatment compared to 50% in the standard of care (SOC, peginterferon alfa-2a plus ribavirin for 48 weeks) historical control group (P = 0.006), 61% in patients receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon alfa-2a, and 79% in patients receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide plus SOC.

Of the 44 patients in the study, 78% (n=40) of patients with HCV genotype 4, 100% (n=3) of patients with HCV genotype 1, and 100% (n=1) of HCV genotype 2, had an SVR with undetectable virus at 24 weeks following end of treatment.

Adverse events reported for these 44 patients were similar to those reported in the STEALTH C-1 trial. Patients treated with nitazoxanide experienced no more side effects than patients who received the SOC therapy. Only one of the 44 patients discontinued therapy due to noncompliance. There were no serious adverse events or discontinuations due to adverse events.

"These data confirm findings of our STEALTH C-1 trial related to safety and efficacy of nitazoxanide in patients infected with HCV genotype 4, show that the nitazoxanide lead-in phase prior to standard of care treatment can be reduced from 12 to 4 weeks, and indicate that ribavirin may not be needed to maintain SVR," said Emmet B. Keeffe, M.D., Chief Medical Officer of Romark Laboratories.

-- "Potential Role for Nitazoxanide in Combination with STAT-C Agents

for the Inhibition of HCV Replication Without the Development of

Resistance," Korba, et al. Sunday Nov. 2, 5:30 PM PST (Oral Session

#115)

This oral presentation by Brent Korba, Ph.D. of Georgetown University Medical Center, described preclinical studies demonstrating synergistic interactions between nitazoxanide and direct-acting antiviral drugs targeting NS5B (2'C methylcytidine and HCV-796) and NS3 (telaprevir and BILN-2061) in HCV replicons. Nitazoxanide was also active against telaprevir- and 2'C methylcytidine-resistant mutant replicons. The authors concluded that nitazoxanide is a good candidate for combination therapies with STAT-C agents in the absence of interferon or ribavirin.

-- "Nitazoxanide (NTZ) is an Inducer of eIF2a and PKR

phosphorylation," Elazar et al., Tuesday, November 4, 8:00 AM -

12:30 PM PST (Poster #1881)

This poster presentation by Menashe Elazar, Ph.D. of the Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University School of Medicine, showed that nitazoxanide increases the intracellular levels of phosphorylated eukaryotic translation initiation factor 2alpha (eIF2alpha), a key mediator of host cell antiviral defenses. Co-treatment with interferon increased nitazoxanide-induced eIF2alpha phosphorylation. . Nitazoxanide was also shown to increase the phosphorylation of protein kinase R (PKR), a key step in the activation of PKR's kinase activity towards eIF2alpha.

"Data presented in each of these communications has provided important information in guiding the ongoing clinical development of nitazoxanide," said Dr. Rossignol.

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 (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 Cryptosporidium and Giardia infection.


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

Related biology technology :

1. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
2. Romark Laboratories Names Emmet B. Keeffe, M.D. Vice President and Chief Medical Officer
3. Romark Laboratories Announces Presentation of New Nitazoxanide Data at 59th Annual AASLD Meeting and 50th Anniversary IASL Meeting in San Francisco
4. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
5. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
6. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
7. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
8. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
9. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
10. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
11. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... , ... February 10, 2016 , ... ... the International Society of Pharmaceutical Engineering (ISPE) Rocky Mountain Chapter 21st Annual Vendor ... expecting to fill more than 100 tables for its annual event, which will ...
(Date:2/10/2016)... ... February 10, 2016 , ... PatientCrossroads announces ... the secure online PatientCrossroads platform, has exceeded both its one-year and overall recruitment ... PROMPT study, which seeks to advance understanding of the hereditary risks for certain ...
(Date:2/10/2016)... ... February 10, 2016 , ... Cenna Bioscience Inc., an ... treatment of Alzheimer’s disease, announced today it has been selected to present at the ... Breakers in Palm Beach, Florida. The purpose of the Forum is to help ...
(Date:2/9/2016)... 9, 2016  Regenicin, Inc. (OTC Bulletin Board: ... the development and commercialization of regenerative cell therapies ... organs, recently reported the Company,s operating results for ... 2016. Lonza America , Inc. (the ... year in the process of consummating an agreement ...
Breaking Biology Technology:
(Date:2/2/2016)... Feb. 2, 2016 Checkpoint Inhibitors for ... Market Are you interested in the future ... for checkpoint inhibitors. Visiongain,s report gives those predictions ... and national level. Avoid falling behind in ... opportunities and revenues those emerging cancer therapies can ...
(Date:2/1/2016)... -- Today, the first day of American Heart Month, the ... first of its kind workplace health solution that leverages ... first application of Watson to ... Welltok will create a new offering that combines AHA,s ... on Welltok,s health optimization platform. The effort is intended ...
(Date:1/25/2016)... , Jan. 25, 2016  Glencoe Software, the ... pharma and publication industries, will provide the data management ... Centre (NPSC). ... Phenotypic analysis measures ... whole organisms, allowing comparisons between states such as health ...
Breaking Biology News(10 mins):