XTL Biopharmaceuticals Announces Positive Interim Phase IIa Results In Chronic Hepatitis B Study
REHOVOT, Israel, Dec. 10 /PRNewswire/ -- XTL Biopharmaceuticals Ltd. (LSE: XTL) announces interim results from a phase 2a clinical study of XTL-001 in chronic hepatitis B (HBV) patients in combination with lamivudine, the standard treatment. The preliminary data indicates that XTL-001 in combination with lamivudine resulted in a significant lowering of viral DNA and antigen levels after only one week of treatment. This effect appears to be sustained for at least one month (the limit of the data analysed).
Patients in the study were treated with a combination of various doses of XTL-001 or placebo on a background of the standard treatment regimen of lamivudine. The multi-centre, double-blind, dose ranging study is expected to enroll a total of 60 patients in five dosing regimens of XTL-001. Patients receive the combination drug therapy for up to 12 months.
Interim results from 15 patients receiving the combination at 4 weeks indicated that HBV viral DNA was reduced to undetectable levels in 9 out of 15 patients (60%). A greater than 50% reduction in HBV viral surface antigen levels was seen in 7 out of 15 of the patients (47%).
Professor Eithan Galun, Director, Goldyne Savad Institute of Gene Therapy, Hadassah University Hospital and a principal investigator in this study, said: ``While the data set is preliminary, the decreased levels of viral antigen as well as the accelerated reduction in viral DNA is consistent with an enhanced effect on eliminating the HBV virus when using XTL-001 compared with standard therapy alone.''
Dr. Martin Becker, Ph.D., President and CEO of XTL, said: ``These encouraging interim results provide initial validation of our combination therapy strategy for HBV, a chronic disease affecting over 300 million people worldwide. We look forward to seeing continued progress with this and other products in our portfolio during 2002.''
XTL-001 consists of two high affinity human monoclonal antibodies that act at multiple sites on the HBV surface antigen. These antibodies were discovered and developed using XTL's Trimera system, a proprietary technology for generating high affinity human monoclonal antibodies and for creating in vivo systems for bio-validating therapeutics using functional human tissue.
Hepatitis B is one of the most common potentially fatal infectious diseases in the world. The hepatitis B virus is up to 100 times more infectious than HIV, the virus that causes AIDS. Modes of transmission include blood transfusions, contaminated needles, sexual contact, breast milk and open sores. Most people infected with acute hepatitis B have no symptoms and are able to fight off the infection themselves. According to the American Liver Foundation, 5% to 10% of those infected with hepatitis B will become chronic carriers of the virus.
The World Health Organization estimates that approximately 350 million individuals worldwide, or 5% of the world's population, are long-term carriers of hepatitis B in their blood. In the United States, there are over 1 million carriers of hepatitis B and an estimated 200,000 people contract acute hepatitis B each year. Most are unaware that they are infected or have minimal disease with no clinically evident symptoms. However, carriers of the hepatitis B virus have a 200-fold increased chance of developing primary liver cancer, the most common cancer in the world, and a significant number develop cirrhosis of the liver.
A safe and effective vaccine against hepatitis B is available. However, the vaccine is a preventative in that it only benefits those who have not yet been infected by the hepatitis B virus. It is not indicated for the treatment of chronic infection. Most approved treatments only benefit a limited proportion of patients and can have serious adverse side effects.
XTL will host a conference call for analysts today at 11.00 am GMT. Please contact Claire Rowell on +44 (0) 20 7269 7285 for details.
XTL BIOPHARMACEUTICALS LTD.
XTL develops novel therapeutics to treat life-threatening infectious diseases using fully human monoclonal antibodies and small molecule drugs. XTL's competitive advantage lies in its ability to leverage both its proprietary human tissue-based in vivo disease models and fully human monoclonal antibody technology to validate and develop promising drug candidates. The Company's growing pipeline of therapies, designed to combat chronic viral infections, drug-resistant bacteria and serious systemic fungal infections, comprises internally developed products as well as those being co-developed with a number of biopharmaceutical partners. For more information about XTL, visit the Company's web site at www.xtlbio.com . |
