Navigation Links
Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
Date:8/19/2007

International Clinical Data to be Presented at the 58th Annual Meeting of

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

TAMPA, Fla., Aug. 15 /PRNewswire/ -- Romark Laboratories announced that it has initiated a phase II clinical trial of Alinia(R) (nitazoxanide) for treating chronic hepatitis C in the United States.

The clinical trial is designed to evaluate the effectiveness and safety of Alinia tablets administered in combination with Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin) in 60 patients with chronic hepatitis C genotype 1 who have failed to respond to standard therapy (peginterferon and ribavirin). Pegasys and Copegus are being provided under a collaborative agreement between Romark and F. Hoffmann-La Roche Ltd.

"We are excited to be participating in this clinical trial," said David Nelson, M.D., Associate Professor of Medicine, Medical Director of Liver Transplantation, and Chief of the Hepatobiliary Disease Section at the University of Florida. "There is a critical need for new therapies for patients with hepatitis C, particularly those who have already failed existing therapies."

The company also announced that interim data from an international clinical trial in patients with chronic hepatitis C will be communicated at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in early November 2007.

"Initiation of the US study and communication of our international data represent important milestones for our development program," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark who invented nitazoxanide and is leading its clinical development. "We are enthusiastic about the results to be presented at the upcoming AASLD meeting and the opportunity to develop an important new treatment for patients suffering from chronic hepatitis C."

The company's STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C) development program is being directed in collaboration with the Division of Gastroenterology and Hepatology at Stanford University School of Medicine by Emmet B. Keeffe, M.D., Jeffrey S. Glenn, M.D., Ph.D. and Dr. Rossignol who is also a Stanford affiliate.

Nitazoxanide is the first of a new class of small molecule drugs called the thiazolides that target cell signaling pathways used in viral replication. Data related to the in vitro activity of nitazoxanide against virus replication in hepatitis C virus (HCV) replicons was presented earlier this year at the 20th International Conference on Antiviral Research.

Stephen A. Harrison, M.D., Chief of Hepatology at Brooke Army Medical Center in Fort Sam Houston, Texas, said, "The potential for use of nitazoxanide in the treatment of chronic hepatitis C is exciting. To better optimize treatment outcomes for patients, we need new antiviral drugs that can be used safely and effectively in combination with existing drugs or with other new drugs in development."

STEALTH C Clinical Development Program

The US and international clinical trials described above comprise part of the company's STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C) clinical development program, a series of clinical trials designed to evaluate the safety and efficacy of Alinia tablets in combination with peginterferon or peginterferon and ribavirin in patients with chronic hepatitis C.

The STEALTH C-1 trial, conducted in Egypt in interferon-experienced and naive patients with chronic hepatitis C genotype 4, is a phase II randomized controlled trial evaluating the effectiveness and safety of three treatment regimens: (i) Alinia administered 500 mg twice daily for 12 weeks followed by Alinia-Pegasys combination therapy for 36 weeks, (ii) Alinia 12 weeks followed by Alinia-Pegasys-Copegus combination therapy for 36 weeks and (iii) Pegasys- Copegus combination therapy for 48 weeks (standard of care). The study randomized 120 patients. Patients enrolled in this trial have reached the end of treatment and are undergoing follow-up for sustained virologic response. Data from the STEALTH C-1 clinical trial is expected to provide important efficacy and safety data that will guide the continuing development of nitazoxanide for treating chronic hepatitis C. Interim data from this trial will be presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in early November 2007.

The STEALTH C-2 trial is a randomized double-blind placebo-controlled trial conducted in the United States in 60 patients with chronic hepatitis C genotype 1 who have previously failed to respond to peginterferon and ribavirin combination therapy. This trial is designed to evaluate the effectiveness and safety of Alinia administered 500 mg twice daily for 4 weeks followed by Alinia-Pegasys-Copegus combination therapy for 48 weeks compared to placebo for 4 weeks followed by placebo-Pegasys-Copegus combination therapy for 48 weeks (standard of care).

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. (http://www.romark.com) is a 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.


'/>"/>
SOURCE Romark Laboratories, L.C.

Copyright©2007 PR Newswire.

Related medicine technology :

1. Malvern initiates European user group meetings for chemical imaging
2. Genetic Analysis Systems Enter the Clinical Mainstream
3. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
4. Large Geographic Differences in EpiPen Prescriptions in the U.S., From the Journal of Allergy and Clinical Immunology
5. Sygnis Pharma AG announces date for presentation of clinical results
6. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Clinical Data Suggest Decreased Bleeding Risk in People With Severe Hemophilia A While Maintaining Factor VIII Levels Above One Percent
8. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
9. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
10. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
11. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... 23. Februar 2017 LG Innotek hat heute ... Die Sterilisationsleistung beträgt das 1,5-fache des 45-mW-Moduls der Konkurrenz. ... Bereich zwischen 200 und 280 nm und eignet sich damit ... es ihre DNA zerstört. Das Produkt von LG Innotek ... ...
(Date:2/23/2017)... and Markets has announced the addition of the "Menopause Drugs Price ... ... Analysis and Strategies - 2016, provides drug pricing data and benchmarks in ... What are the key drugs marketed for Menopause ... market? What are the unit prices and annual treatment ...
(Date:2/23/2017)... Calif. , Feb. 23, 2017 ... company focused on the development and commercialization of ... pain, announced that it will release fourth quarter ... Thursday, March 2nd, 2017. AcelRx management will host ... Time (1:30 p.m. Pacific Time) on March 2 ...
Breaking Medicine Technology:
(Date:2/23/2017)... ... February 23, 2017 , ... The American Cleft Palate-Craniofacial Association (ACPA) ... Meeting. KLS is a longtime supporter of the event. , "We are pleased ... Sponsor," said Dr. Bob Havlik, 2017 ACPA President. "KLS Martin has a long track ...
(Date:2/23/2017)... ... February 23, 2017 , ... On April ... diverse symposium on “Doping in Sport: How the Culture Might Change,” ... Hampton LLP. The symposium will be held at Pepperdine University in Malibu, California. ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... and community for those in the fight against cancer, has produced a seminal ... success. HRA will release top-line findings in a webinar, Defining Compassionate Care ...
(Date:2/23/2017)... York (PRWEB) , ... February 23, 2017 , ... Curemark, ... the safety and efficacy of CM-AT in children aged 3-8 with Autism, is now ... clinical sites already enrolling children across the United States. , “There are currently ...
(Date:2/22/2017)... ... February 22, 2017 , ... Our high-octane society demands ... the sharpest brain. , Power On, a mental performance enhancer from Modus Nutrition, ... brain. Each capsule contains Cognizin® Citicoline, a branded form of the brain health ...
Breaking Medicine News(10 mins):