XTL Biopharmaceuticals' Human Monoclonal Antibody Therapeutic For Chronic Hepatitis B Enters Phase I Clinical Trials / First Product Developed Using Company's P

REHOVOT, Israel (PROTEXT) - XTL Biopharmaceuticals, Ltd.announced today the initiation of a Phase I study of XTL001, aninvestigational monoclonal antibody (MAb) product, to evaluatethe safety profile and antiviral activity of the compound inchronically infected hepatitis B (HBV) patients. XTL001, acombination of two human MAbs, is the Company's lead compound andthe first to be discovered and developed utilizing itsproprietary Trimera(XTL) system, a breakthrough method forproducing high- affinity, fully human monoclonal antibodies inmice. The clinical study is being conducted in the United Statesand Israel by researchers at the University of California SanFrancisco, Stanford University and the Hadassah UniversityHospital, Jerusalem. "There is a critically important need for new therapeutics totreat HBV infection. Currently, less than half of chronicallyinfected patients have responded to the available treatments, andnew mutants which are resistant to these drugs continue toemerge," stated Dr. Eithan Galun, from the Liver Unit at HadassahUniversity Hospital, Director of the Goldyne Savad Institute ofGene Therapy and a co-Principal Investigator of the study. "Basedon preclinical studies in the proprietary Trimera(XTL) modelsystem of human HBV, XTL001 looks to be a promising newtherapeutic candidate for this serious disease. Studies haveshown that it acts at multiple sites on the HBV surface antigenwith a high degree of specificity, enabling it to effectivelyneutralize the virus. Additionally, XTL001 expresses asynergistic effect when used in combination therapy with otherantiviral drugs, resulting in the reduction of viral loads for anextended duration." "This is the first of our drug candidates to enter clinicaltrials that was discovered, tested and validated utilizing ourproprietary Trimera(XTL) technology," stated Martin Becker,Ph.D., President and Chief Executive Officer of XTL. "Theinitiation of this study validates our unique approach ofgenerating novel MAb therapeutics as well as validating them inthis versatile system. We are also excited to be working withthese prestigious research institutions in two parts of the worldto advance our study of XTL001 in the clinic. The results ofpreclinical studies have been very encouraging and we lookforward to receiving initial data on the safety profile andantiviral activity from this human clinical study." XTL001 is a combination of two high-affinity, fully human MAbsthat bind to distinct sites on the surface antigen of HBV toneutralize the virus and limit viral escape. This trial is a doseranging study consisting of 15 chronically infected HBV patients.The patients are divided into five dose groups consisting ofthree patients each. The patients' viral load and generaltolerance will be monitored at several intervals to determine theantiviral activity and safety of the drug. The Company expectsthat this will be followed by a Phase Ib dose escalation study. The Trimera(XTL) system is a breakthrough method which enablesa normal mouse to carry functional human tissues and/or a humanimmune system. Trimera(XTL) can capitalize on a pre-existingclinically relevant immune response to enable the development ofimproved antibodies with enhanced specificity and potency for useas therapeutic drugs. Using the Trimera(XTL) system results inthe rapid production of human monoclonal antibody-producing cellswithin a few weeks. In addition, using the Trimera(XTL) diseasemodels can increase the probability of clinical success byoptimizing the selection of targets/compounds early in thepreclinical stages of development. This is particularly valuablefor diseases like HBV and HCV where drug development has beenseriously hampered by the absence of adequate small animalmodels. Other Principal Investigators of the study include ProfessorEmmet B. Keefe, M.D., Medical Director, Liver Transplant Programand Chief of Clinical Gastroenterology at Stanford University,Professor Daniel Shouval, M.D., Head of the Liver Unit and ChiefPhysician at the Hadassah University Hospital, and NorahTerrault, M.D., M.Ph., Assistant Adjunct Professor, Division ofGastroenterology at the University of San Francisco. XTL is a biopharmaceutical company developing fully humanmonoclonal antibody-based therapeutics with a primary focus oninfectious diseases. The Company applies its proprietary drugdiscovery and development "engine," the Trimera(XTL) system, toproduce high affinity, fully human antibodies to a broad range ofdisease targets including hepatitis B (HBV) and hepatitis C(HCV). In addition, XTL has unique, high-value animal models ofhuman diseases including models for testing HBV and HCVtherapeutic drugs. For more information about XTL, visit theCompany's website at http://www.xtlbio.com. A backgrounder on utilizing the Trimera(XTL) System formonoclonal antibody production is available upon request. otsOriginal Text Service: XTL Biopharmaceuticals, Ltd. Internet:http://www.newsaktuell.de Contact: Martin Becker, Ph.D.,President and CEO of XTL Biopharmaceuticals, Ltd., 972-8-940-5134, becker@xtlbio.com, or Glenn Kazo, Vice President, BusinessDevelopment and General Manager, XTL Biopharmaceuticals, Inc.,603-878-9857, gkazo@xtlbio.com, or Douglas MacDougall or KariLampka of Feinstein Kean Partners Inc., 617-577-8110 Web site:http://www.fkpi.com Web site: http://www.xtlbio.com

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