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PROLOR Biotech (PBTH) to Present Preclinical Data on Its Long-Acting Clotting Factors VIIa and IX at European Hemophilia Conference


2/23/2012 9:11:40 AM

NES-ZIONA, Israel, Feb. 23, 2012 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), today announced that PROLOR scientist Dr. Gili Hart will present data on its long-acting clotting factors in preclinical development for the treatment of hemophilia at the European Association for Haemophilia and Allied Disorders (EAHAD) 5th Annual Congress. Dr. Hart's presentation, "FVIIa-CTP and FIX-CTP, novel long-acting coagulation factors with prolonged hemostatic effect and improved recovery in FVIII-/- and FIX-/- mice," is part of a moderated poster session (poster #21) that will take place tomorrow at the EAHAD Congress in Rome, Italy.

In her poster presentation, Dr. Hart will discuss data from preclinical studies of PROLOR's long-acting versions of Factor VIIa and Factor lX. Top-line results of the Factor VIIa studies were recently reported by PROLOR. They showed that compared to commercially available Factor VIIa, hemophilic mice receiving Factor VIIa-CTP demonstrated a superior survival rate over a longer time period following a bleeding challenge, a superior and longer-lasting generation of the pro-clotting enzyme thrombin, and significantly higher in vivo recovery, a pharmacokinetic measure of clotting activity.

Dr. Hart also will present data from preclinical studies of Factor lX-CTP. PROLOR reported top-line results of these studies last year. They showed that Factor IX-CTP demonstrated a significantly longer duration of clotting activity in the hemophilic mice model compared with commercially available Factor IX. Bleeding episodes were significantly shorter and less intense for the group treated with Factor IX-CTP. In addition, none of the animals treated with Factor IX-CTP had any spontaneous re-bleeding events, compared with a 50% incidence of re-bleeding events for the group treated with commercial Factor IX.

PROLOR CEO Dr. Abraham Havron commented, "The EAHAD Annual Congress brings together leading hemophilia researchers and clinicians from around the globe, and we look forward to the opportunity to share with them the promising results we have seen to date in preclinical studies of our long-acting clotting factors for the treatment of hemophilia."

ABOUT HEMOPHILIA

Hemophilia is a group of hereditary genetic disorders that impair the body's ability to control blood clotting, or coagulation. Patients with hemophilia do not produce adequate amounts of Factor VIII or Factor IX proteins, which are necessary for effective blood clotting. In severe hemophiliacs even a minor injury can result in blood loss that may continue for days or weeks, and complete healing may not occur, leading to the potential for debilitating permanent damage to joints and other organs and premature death. According to the World Health Organization, more than 400,000 people worldwide have hemophilia. Patients with hemophilia are currently treated with recombinant versions of the missing clotting factors. In addition, Factor VIIa is used as a replacement therapy for hemophilia patients who are resistant to Factor VIII therapy. The commercially available recombinant clotting factors have enabled many hemophiliacs to live near-normal lives, but frequent injections and/or blood transfusions may be required.

ABOUT THE EUROPEAN ASSOCIATION FOR HAEMOPHILIA AND ALLIED DISORDERS

The European Association for Haemophilia and Allied Disorders (EAHAD) is a multi-disciplinary association of healthcare professionals who provide care for individuals with haemophilia and other bleeding disorders. The purpose of the EAHAD is to promote clinical care, education and research for this group of patients across the continent. For more information, visit the Association website at http://www.eahad.org.

ABOUT PROLOR

PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins. PROLOR is currently developing a long-acting version of human growth hormone, which has successfully completed a Phase II clinical trial. It also is developing long-acting versions of Factor VIIa and Factor IX for hemophilia and a GLP-1/Glucagon dual receptor agonist peptide for diabetes and obesity, as well as agents for atherosclerosis and rheumatoid arthritis, which are all in preclinical development. For more information, visit www.prolor-biotech.com.

Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "intends," "estimates," "suggests," "has the potential to" and other words of similar meaning, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR's long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect PROLOR's business and prospects, including the risks that PROLOR may not succeed in generating any revenues or developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1 and other products; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from Israel's Office of the Chief Scientist is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR's filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

PROLOR CONTACT:

MEDIA CONTACT:

Shai Novik, President

Barbara Lindheim

PROLOR Biotech, Inc.

GendeLLindheim BioCom Partners

Tel: +1 866 644-7811

+1 212 584-2276

Email: shai@prolor-biotech.com

blindheim@biocompartners.com

SOURCE PROLOR Biotech, Inc.



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