Navigation Links
iTherX Initiates Phase 1b Study of First-in-Class Hepatitis C Virus Entry Inhibitor ITX-5061
Date:3/15/2011

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 CHepatitis 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 iTherXiTherX 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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Inovio Pharmaceuticals Partner ChronTech Initiates Phase II Clinical Trial of Hepatitis C Virus DNA Vaccine Using Inovios Electroporation Delivery Technology
2. Conatus Pharmaceuticals Initiates Confirmatory Phase 2 Clinical Trial of CTS-1027 for the Treatment of Hepatitis C Virus (HCV)
3. New Mexico Software Initiates Medical Second Opinion Service via Telemedicine for Remote Consultation Review
4. Tarsa Therapeutics Completes Phase III Trial of its Oral Calcitonin for Treatment of Postmenopausal Osteoporosis and Initiates Phase II Trial in Osteoporosis Prevention
5. Amicus Therapeutics Initiates Phase 2 Clinical Trial Evaluating Amigal™ Co-administered with Enzyme Replacement Therapy
6. American Regent Initiates Nationwide Voluntary Recall of Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium, 5 mL Single Dose Vial, Lot # 0048 Due to Translucent Visible Particles
7. American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP
8. BioMarin Initiates Pivotal Phase 3 Trial for GALNS for the Treatment of MPS IVA
9. Zacks Investment Research Initiates Coverage on Viral Genetics
10. ChemoCentryx Initiates Phase I Clinical Trial of CCX832, the First Small Molecule Inhibitor of ChemR23
11. BioMarin Initiates Phase 1/2 Trial for BMN 701 for the Treatment of Pompe Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... FinancialBuzz.com News Commentary  ... According to new data published Arcview ... legal cannabis market is projected to continue to grow at ... the current presidential administration. The report created by Arcview,s data ... growth in this industry are the passage and subsequent implementation ...
(Date:3/24/2017)... Research and Markets has announced the addition of the ... report to their offering. ... The Deep Learning: Drug Discovery and Diagnostics Market, 2017-2035 report ... of deep learning solutions within the healthcare domain. Primarily driven by ... novel solution to generate relevant insights from medical data. ...
(Date:3/24/2017)... YORK , March 24, 2017 ... and Equipment stocks, which are: Neovasc Inc. (NASDAQ: NVCN), Hologic ... Heart Inc. (NASDAQ: SSH ). These companies are ... its prior gains on Thursday, March 23 rd , 2017, ... afternoon, while shares of health care companies in the S&P ...
Breaking Medicine Technology:
(Date:3/24/2017)... SC (PRWEB) , ... March 24, 2017 , ... Digital ... is excited to announce the opening of a Greenville, South Carolina location. ... for digital progress in Greenville. , “We’ve been working with South Carolina clients for ...
(Date:3/24/2017)... , ... March 24, 2017 , ... The iaedp Foundation, ... other medical professionals caring for those suffering from the full spectrum of disordered eating, ... as eating disorders professionals from nearly all 50 states and several countries converged on ...
(Date:3/24/2017)... PA (PRWEB) , ... March 24, 2017 , ... ... Oncology Nursing Society (ONS) wanted to create a communications platform that positions them ... this goal, Elliance and ONS reinvented their online publication as an always-on, always-fresh ...
(Date:3/24/2017)... , ... March 24, 2017 , ... Viewers who like ... of critical historical facts, cultural practices, goods, services, and societal issues tend to appreciate ... look into the popular practice of utilizing running events for causes around the world. ...
(Date:3/24/2017)... ... March 24, 2017 , ... “Finding ... God #TruthwithGrace”: a devotional journal chronicling the writer’s path toward true communion with ... Walk with God #TruthwithGrace” is the creation of published author Lea Michelle Johnson, ...
Breaking Medicine News(10 mins):