March 15, 2011

Gilead's Hepatitis C Therapy Called Successful

CDC 3-14-11

Abstract

In early-stage study results reported recently to investors, Gilead Sciences Inc. said its four-drug combination eliminated hepatitis C virus in patients. The trial examined the use of Gilead GS-9256 and GS-9190 with the standard drugs ribavirin and peginterferon. The researchers plan to present their findings at the annual meeting of the European Association for the Study of the Liver, which begins March 30 in Berlin.

Source
http://www.sfgate.com/

Date of Publication
03/09/2011

Author
Kristen Hallam, Bloomberg News

Article Type
General media

Article Category
News Briefs

Source
Public release date: 15-Mar-2011

Contact: Ye-Ru Wang
wjg@wjgnet.com
86-105-908-0039
World Journal of Gastroenterology

The incidence and mortality associated with hepatocellular carcinoma (HCC) have been increasing worldwide, and hepatitis C virus (HCV) infection plays an important role in the pathogenesis of HCC. Previous studies have suggested that host factors, such as sex, alcohol consumption, smoking, diabetes mellitus, and obesity, are important risk factors for HCC. Meanwhile, it has been reported that HCV infection causes insulin resistance and leads to oxidative stress, potentiating fibrosis and hepatic carcinogenesis. However, the factors that influence the development of HCC in HCV-infected patients remain largely unknown.

A research article published on February 21, 2011 in the World Journal of Gastroenterology addresses this question. The authors hypothesized that obesity influences the time to onset of HCC related to HCV infection, which is reflected in the patient's age at onset. To test this hypothesis, they investigated the relationship between body mass index (BMI) and lifestyle factors and age at onset of HCC in HCV-infected patients.

The research showed that the underweight patients (BMI < 18.5 kg/m2), tended to be older at HCC onset than patients within the normal weight range (BMI 18.5󈞅 kg/m2).

The results suggest that achieving an adequate body weight along with a reduction of alcohol intake in patients with chronic hepatitis C could help prevent hepatic carcinogenesis.

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Reference: Akiyama T, Mizuta T, Kawazoe S, Eguchi Y, Kawaguchi Y, Takahashi H, Ozaki I, Fujimoto K. Body mass index is associated with age-at-onset of HCV-infected hepatocellular carcinoma patients. World J Gastroenterol 2011; 17(7): 914-921

http://www.wjgnet.com/1007-9327/full/v17/i7/914.htm

Correspondence to: Toshihiko Mizuta, MD, PhD, Department of Internal Medicine, Saga Medical School, 5-1-1 Nabeshima, Saga 8498501, Japan. mizutat@med.saga-u.ac.jp

Telephone: +81-952-342362 Fax: +81-952-342017

About World Journal of Gastroenterology

World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H. pylori infection and provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2009 IF: 2.092. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th day of every month. WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the name of China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.

Source
-- Preclinical Studies Show that ITX-5061 Prevents Hepatitis C from Invading Liver Cells --

SAN DIEGO, March 15, 2011 /PRNewswire/ -- iTherX, a pharmaceutical company dedicated to discovering and developing a new class of therapies for hepatitis C, today announced that it has commenced patient recruitment in an open-label, proof-of-concept Phase 1b study of its lead compound ITX-5061 in liver transplant patients with hepatitis C virus infection (HCV). ITX-5061 represents a first-in-class compound that inhibits entry of the hepatitis C virus into liver cells.

"ITX-5061 possesses a unique mechanism of action that prevents the hepatitis C virus from entering liver cells and has demonstrated potent preclinical antiviral activity against all HCV genotypes.In addition, it has already demonstrated safety in more than 280 subjects," said Jeffrey McKelvy, PhD, MD, President and Chief Executive Officer of iTherX. "We hope ITX-5061 will significantly improve long-term transplant outcomes."

The primary objective of the Phase 1b clinical trial will be to assess the safety and tolerability of ITX-5061 in liver transplant patients. The study will also assess HCV viral load for three months after liver transplantation to determine if ITX-5061 has any immediate and/or sustained impact on viral kinetics in treated patients. Approximately 20 patients will be enrolled into one of two cohorts: one group will receive supportive care only, while the second cohort will also receive ITX-5061 at a150 mg daily dose for seven days. The trial is being conducted at the University of Birmingham, UK under the direction of David Mutimer, MBBS, MD, FRACP, FRCP, Reader in Hepatology at Birmingham University and Consultant Hepatologist to the Birmingham QE Hospital Liver and Hepatobiliary Unit.

Preclinical studies have shown ITX-5061 to be a potent and selective inhibitor of HCV entry into hepatocytes, capable of preventing virus binding/fusion and cell to cell spread, suggesting ITX-5061 may reduce re-infection rates following liver transplant.

"Recurrence of HCV infection among liver transplant patients is universal and immediate. Clinicians have long sought ways to prevent re-infection by HCV, improve transplant patient outcomes and extend survival," said Dr. Mutimer. "The potential of ITX-5061 to prevent or reduce viral infection of the new liver by halting viral-entry into healthy cells represents an extraordinarily novel approach, and we are excited to advance the clinical development of this promising antiviral compound."

The Phase 1b trial of ITX-5061 in liver transplant recipients is funded through an educational grant from iTherX with the National Institute of Health Research Biomedical Research Unit (NIH-BRU Birmingham).

This is a second clinical study for ITX-5061 in hepatitis C. The first study, a single agent placebo-controlled dose response study commenced in August 2010, is being conducted in treatment naïve chronic HCV patients by the AIDS Clinical Trial Group of the National Institute of Allergy and Infectious Diseases.

About Hepatitis C

Hepatitis C virus (HCV) infection, a disease that attacks the liver, affects 170 million people worldwide. The majority of individuals develop chronic infection and up to 20 percent of infected individuals will develop cirrhosis with the attendant risks of liver failure and liver cell cancer. The current standard of care is combination antiviral treatment with pegylated interferon-alpha and ribavirin, which results in a cure for approximately half of all patients. Unfortunately, many patients present with clinically silent infection or advanced disease, at which time antiviral treatment is generally ineffective. For these patients, liver transplantation may be the only option. End-stage liver disease due to chronic HCV infection has become the leading indication for liver transplantation in the United States. Recurrence of hepatitis C virus after liver transplantation is inevitable and disease progression is rapid when compared with disease in the non-transplanted liver.

About iTherX

iTherX is a pharmaceutical company focused on the discovery and development of a novel class of antiviral therapeutics that act by blocking entry of the hepatitis C virus into liver cells to halt the spread of infection. The company's lead program, ITX-5061, is currently in Phase 1b clinical studies intended to evaluate antiviral activity and safety in patients with HCV infection. In addition to ITX-5061, iTherX is leveraging its proprietary expertise in molecular virology and medicinal chemistry to establish a pipeline of viral entry inhibitors, with additional candidates currently undergoing preclinical testing.

CONTACTS:
BCC Partners
Karen Bergman or Susan Pietropaolo, +1.650.575.1509 or +1.845.638.6290

SOURCE iTherX

Source