Phase IIa results for Miravirsen (Santaris Pharma) show prolonged antiviral activity in Hepatitis C patients - 20-Apr-2012
Data from a Phase IIa trial shows that Miravirsen (SPC3649), from Santaris Pharma, given as a four-week monotherapy treatment for Hepatitis C provided robust dose-dependent anti-viral activity with a mean reduction of 2 to 3 logs from baseline in HCV RNA (log10 IU/mL) that was sustained well beyond the end of therapy. The data showed the drug was safe, well tolerated and provided prolonged antiviral activity, with no signs of viral resistance. Additonally, four out of nine patients treated at the highest dose became HCV RNA undetectable during the study, providing clinical evidence that miravirsen's unique mechanism-of-action offers the potential for treatment cures when used as monotherapy. The data was presented by Dr. Henk Reesink, Academic Medical Center, University of Amsterdam at the the International Liver Congress April 2012. Title: "Final Results: Randomized, Double-Blind, Placebo-Controlled Safety, Anti-Viral Proof-of-Concept Study of Miravirsen, an Oligonucleotide Targeting miR-122, in Treatment-Naive Patients with Genotype 1 Chronic HCV Infection."
Related News
Phase II data shows ABT 450/r, ABT 267, ABT 333 (Abbvie) successful in patients with Hepatitis C
Phase III trial of BI 201335 (Boehringer) succesful for Hepatitis C patients
Miravirsen (Santaris Pharma) Phase II trial for Hepatitis C is reported in NEJM
Janssen R&D files TMC 435 to the FDA for Hepatitis C
Pegasys (Roche) European indication expanded by EMA in Hepatitis C to include to children
Positive results from Phase III trial of BI 201335 (Boehringer) for Hepatitis C patients
FISSION and Neutrino studies success for GS 7977 (Gilead Sciences) for Hepatitis C
CHMP recommends Pegasys(Roche) for paediatric use in Hepatitis C
Related Hepatology Information
Hepatology Clinical Guidelines
Entecavir for the treatment of chronic hepatitis B
NICETelbivudine for the treatment of chronic hepatitis B
NICEHepatology Clinical Trials
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Clinicaltrials.gov 20 March 2013New Methods to Measure the Immune Response to Hepatitis B Vaccine
Clinicaltrials.gov 18 March 2013Hepatology Medical Journal Abstracts
Prediction of early allograft dysfunction using serum phosphorus level in living donor liver transplantation
Transplant International 25 January 2013Transcapsular arterial neovascularization of liver transplants increases the risk of intraoperative bleeding during retransplantation
Transplant International 25 January 2013Hepatology Medical Apps
Liver Guide
£1.49
Liver Disease
Free
