Navigation Links
Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at EASL 2008

Findings Include 80% SVR12 Rate with Nitazoxanide-Based Combination Therapy

and New Insights into Mechanism of Action of Nitazoxanide

MILAN, Italy, April 23 /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 four presentations made at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL), held in Milan, Italy this week.

"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., Director of the Romark Institute for Medical Research and discoverer of nitazoxanide. "These data also provide interesting insights into the mechanism of action of nitazoxanide and confirm previous findings related to its safety."

The four presentations include:

-- An oral presentation, titled, "Randomized Controlled Trial of

Nitazoxanide-Peginterferon-Ribavirin, Nitazoxanide-Peginterferon and

Peginterferon-Ribavirin in the Treatment of Patients with Chronic

Hepatitis C Genotype 4," reported final 24-week post-treatment

sustained virologic response (SVR) rates for the company's STEALTH C-1


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 (SOC) 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 SOC with peginterferon plus ribavirin (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

peginterferon alfa-2a (Pegasys(R), Hoffman LaRoche) 180 micrograms once

per week; nitazoxanide was administered as one 500 mg tablet twice

daily; and ribavirin (Copegus(R), Hoffman LaRoche) was administered as

1,000 or 1,200 mg daily according to body weight. Analysis of data was

by intention to treat.

In treatment-naive patients, combination therapy with nitazoxanide plus

SOC resulted in a SVR24 rate of 79%, compared with 50% for those

treated with SOC without nitazoxanide (P=0.023). When nitazoxanide was

combined with peginterferon alone, the observed SVR24 rate in this

group was 61%. In 24 treatment-experienced patients, the addition of

nitazoxanide to SOC for 36 weeks resulted in a 25% rate of SVR,

compared with 8% when nitazoxanide was combined with peginterferon

alone. The patients treated with nitazoxanide experienced no more side

effects than patients who received the SOC.

Interim results of this trial were presented at the 58th Annual Meeting

of the American Association for the Study of Liver Diseases (AASLD) in

Boston, MA.(1)

-- A poster presentation, titled "Evaluation of a 4-week Lead-in Phase

With Nitazoxanide Prior to Nitazoxanide+Peginterferon in Treating

Chronic Hepatitis C," demonstrated that reducing a nitazoxanide lead-in

phase from 12 to 4 weeks, followed by the addition of SOC therapy, does

not compromise virologic response rates in a patient population with

different genotypes, predominately genotype 4.

Replicon studies and an early clinical experience (unpublished)

indicated that treatment with nitazoxanide alone prior to adding

interferon potentiates the activity of combination therapy with

nitazoxanide plus peginterferon. The STEALTH C-1(2) trial used 12

weeks of lead-in therapy with nitazoxanide alone. This clinical study

was designed to evaluate the effect of reducing the lead-in phase from

12 weeks to 4 weeks.

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. Romark's STEALTH C-1 trial (see description

above) was used as an historical control, where randomized patients

were treated for 12 weeks with nitazoxanide before adding SOC treatment.

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 12 weeks after the end of treatment (SVR12) compared

to 50% in the SOC historical control group (P = 0.004), 61% in patients

receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of

nitazoxanide plus peginterferon, 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 undetectable virus at 12 weeks following end of


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 show that the nitazoxanide lead-in phase prior to standard of care treatment can be reduced from 12 to 4 weeks with no apparent impact on virologic response rates," said Jean-Francois Rossignol, M.D., Director of the Romark Institute for Medical Research and lead author of the study.

-- Data from a poster presentation, "Randomized, Double-Blind Placebo-

Controlled Trial of Nitazoxanide in the Treatment of Patients with

Chronic Hepatitis C Genotype 4" showed that nitazoxanide monotherapy

for 24 weeks did not produce adverse events significantly different

from that of a placebo and suggest that monotherapy with nitazoxanide

may be effective in achieving SVR in a limited subset of patients with

low viral load.

In this randomized, controlled study, 50 treatment-nave patients with

chronic hepatitis C genotype 4 were randomized to receive one

nitazoxanide 500 mg tablet or a matching placebo tablet twice daily for

24 weeks. Baseline viral loads and other disease characteristics were

similar between groups. Seven of 23 patients (34%) receiving

nitazoxanide monotherapy achieved undetectable serum HCV RNA after 24

weeks of therapy, compared with 0 of 24 patients receiving placebo

(P=0.004). Four of these 7 treatment responders (4/23, or 17%) had a

SVR 24 weeks after completion of therapy. Patients not achieving

undetectable HCV RNA did not show significant reductions in viral load

or alanine aminotransferase (ALT) levels. Patients responding to

nitazoxanide treatment had lower viral loads at baseline. Adverse

events were typically mild to moderate and occurred with similar

frequency and severity between the nitazoxanide and placebo groups.

"The study demonstrated the safety of long-term nitazoxanide exposure in patients with chronic hepatitis C. Importantly, this data suggests that thiazolides have an interferon-like mechanism and as a class may have a role as single agent therapy in some patients," said Dr. Emmet Keeffe, chief medical officer for Romark and co-author of the study.

-- An oral presentation by Brent Korba, Ph.D. of, Georgetown University

Medical Center, described preclinical studies showing that treatment of

cells harboring HCV replicons with nitazoxanide or its primary

metabolite, tizoxanide, does not induce viral mutations conferring

resistance to nitazoxanide, tizoxanide, interferon, ribavirin or 2'C-

methyl cytidine (a polymerase inhibitor). The presentation, titled,

"Studies of the Potential for Resistance to Nitazoxanide or Tizoxanide

in HCV-Containing Replicon Cell Lines," also demonstrated that

treatment of HCV replicon cells with tizoxanide potentiates the

antiviral effect of subsequent treatment with interferon (8-fold

decrease in concentration of interferon required to inhibit virus

replication by 90%).

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

Romark is currently enrolling patients for two U.S. clinical trials studying nitazoxanide for the treatment of hepatitis C genotype 1. For more information please visit please visit or and enter the search term "nitazoxanide hepatitis United States."

About Nitazoxanide

Nitazoxanide belongs to a new class of small molecule cell signaling modulators (CSMs) 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 of cryptosporidiosis.

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 Cryptosporidium and Giardia infection.


(1) Interim Data from a Randomized Controlled Trial of Nitazoxanide-

Peginterferon-Ribavirin, Nitazoxanide-Peginterferon and Peginterferon-

Ribavirin in the treatment of Patients with Chronic Hepatitis C

Genotype 4, J. Rossignol et. al.; Proceeds from the 58th Annual

Meeting of the American Association for the Study of Liver Disease

2007, Abstract #178 (presented November 6, 2007).

(2) Ibid.

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

Related medicine technology :

1. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
2. Romark Laboratories Raises $18 Million in Institutional Financing
3. Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1
4. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
5. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
6. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
7. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
8. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
9. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
10. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
11. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
Post Your Comments:
(Date:11/30/2015)... Nov. 30, 2015  PTS Diagnostics, the U.S.-based manufacturer ... analyzers, A1CNow ® systems, and PTS Detect™ ... of patents that will propel the company into the ... Europe . The technology is a ... those on smartphones and tablets, and uses test strip ...
(Date:11/30/2015)... , Nov. 30, 2015 Cumberland Pharmaceuticals (CPIX), ... present live at on December 3, 2015. ... TIME: 3:15p.m. ET LINK: ... LINK: --> ... event where investors are invited to ask the company questions ...
(Date:11/30/2015)... LAKE CITY , Nov. 30, 2015 Booth ... (NYSE: VAR ) will exhibit a broader array of ... of the Radiological Society of North America ... Varian exhibit at the meeting will feature X-ray components "At ... CT tube, a line of products from Varian,s Claymount brand, ...
Breaking Medicine Technology:
(Date:11/30/2015)... , ... November 30, 2015 , ... ... at a University of Delaware Accounting and Management of Information Systems course. Based ... for mid-market businesses. Sommer will speak at before student in the Enterprise Resource ...
(Date:11/30/2015)... , ... November 30, 2015 , ... ... continuing education course in Dallas, TX, on January 29 and 30, 2016. The ... improve the functions of their practices, to learn how to better succeed in ...
(Date:11/30/2015)... PA (PRWEB) , ... November 30, 2015 , ... A ... 15th annual Regional Biotech Conference, organized by the Baruch S. Blumberg Institute. , The ... 100 of the area’s life science and biotechnology leaders for the conference, which focused ...
(Date:11/30/2015)... ... November 30, 2015 , ... HemoTreat™ has announced ... its hemorrhoid ointment to its website. , “Our goal is simple:” says Michael ... hemorrhoids. Adding the comparison chart and ingredient list allows our customers to quickly ...
(Date:11/30/2015)... ... November 30, 2015 , ... ChiliPad , Chili ... maximize recovery through quality sleep. Tim DiFrancesco, training coach for the LA Lakers, ... sleep. ChiliPad precisely regulates the surface temperature of each side of the bed ...
Breaking Medicine News(10 mins):