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New HCV Drug in Phase 1 - XTL Biopharmaceuticals Announces Positive Phase Ia
Clinical Trial Results for Hepatitis C
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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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