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New HCV Drug in Phase 1 - XTL Biopharmaceuticals Announces Positive Phase Ia Clinical Trial Results for Hepatitis C
  First Monoclonal Antibody in the Clinic to Show Activity Against The Hepatitis C Virus
REHOVOT, Israel, Jan. 14 /PRNewswire/ -- XTL Biopharmaceuticals Ltd. (LSE: XTL) today announces positive clinical data on the antiviral activity and safety of XTL-002, being developed for the treatment of hepatitis C virus (HCV) infections. Results of the Phase Ia study, which included 15 chronic HCV patients, indicate that HCV viral RNA levels were reduced in over half the patients following a single dose. No serious adverse events were reported.
The single-centre study, under the regulation of the United States Food and Drug Administration (FDA) and Ministry of Health, Israel, was designed to test safety, tolerability and efficacy of a single-dose of XTL-002 in chronic HCV patients. The 15 patients were divided into 5 groups, with each group receiving 0.25, 1.0, 2.5, 10 or 40mg of XTL-002 in a single intravenous infusion. HCV viral RNA levels were measured pre-infusion and at multiple time intervals following infusion of XTL-002. In 8 out of 15 patients, significant reduction of HCV viral RNA, ranging from 2 to 100 fold, was demonstrated following XTL-002 administration.
XTL-002 is a fully human high-affinity monoclonal antibody which was shown to reduce viral levels of the HCV virus in XTL's proprietary in vivo model, the HCV TrimeraXTL model. This model is being used in conjunction with a variety of corporate and academic partners to screen and evaluate novel compounds to treat HCV. A peer reviewed scientific article on XTL's HCV TrimeraXTL model was recently published in the Journal of Infectious Disease.
Professor Eithan Galun, Director, Goldyne Savad Institute of Gene Therapy, Hadassah University Hospital and a principal investigator in the study, commented:
"XTL-002 is a promising new therapeutic modality for treating chronic HCV patients. In addition, XTL-002 could be employed to prevent HCV re-infection in HCV-associated liver transplant patients, where no drug currently exists."
Martin Becker, Ph.D., President and Chief Executive Officer of XTL, said:
"XTL is the first company to initiate clinical trials with a monoclonal antibody against HCV. We are pleased that the clinical results with XTL-002, though early-stage, suggest that XTL-002 is active against the HCV virus. XTL-002 is the most advanced drug in our broad HCV program, which includes multiple drug candidates that are either fully owned by XTL or co-developed with corporate partners."
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