––Factor VIIa-CTP May Provide Hemophilia Patients Prolonged Protection from Bleeding Episodes––
Nes-Ziona, Israel – February 14, 2012 – PROLOR Biotech, Inc. (NYSE Amex: PBTH), today reported positive results from a comparative study of its biobetter longer-acting version of the hemophilia drug Factor VIIa (Factor VIIa-CTP) in hemophilic mice. The study was designed to measure the potential increase in survival rates, thrombin levels and in vivo recovery of Factor VIIa-CTP when compared with commercially available recombinant Factor VIIa. In vivo recovery is a pharmacokinetic parameter used by researchers that compares actual clotting activity post-dosing to anticipated clotting activity. PROLOR previously announced positive results in an earlier comparative study that measured the increase in half-life and clotting activity of Factor VIIa-CTP compared to commercially available Factor VIIa.
The new study showed that compared to commercially available Factor VIIa, hemophilic mice receiving PROLOR’s Factor VIIa-CTP demonstrated:
A superior survival rate over a longer time period following a bleeding· challenge.
Superior and longer-lasting generation of thrombin, a key· pro-clotting enzyme.
Significantly higher in vivo recovery.·
“The results of our second Factor VIIa-CTP preclinical study are consistent with the results we obtained from the previous study, and we believe they are very promising,” noted Shai Novik, President of PROLOR. “With these positive results, we now have what we believe could be a highly competitive coagulation factor that could potentially become a leader in the hemophilia market.”
“There is great need among hemophilia patients and their physicians for new therapies that will provide prolonged protection from bleeding,” said Dr. Abraham Havron, CEO of PROLOR. “The encouraging results seen in our preclinical hemophilia studies suggest that Factor VIIa-CTP may be able to offer an improved therapeutic option for hemophiliacs by reducing the frequency of injections, controlling bleeding more effectively and significantly improving their quality of life.”
Dr. Havron added, “The fact that our CTP technology has now demonstrated its efficacy in enhancing the longevity of Factor VIIa and Factor IX, which are both enzymes, is another confirmation of the ability of this technology to prolong the biological activity of a variety of therapeutic proteins belonging to different functional families.”
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 continues 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. Commercially available recombinant clotting factors have enabled many hemophiliacs to live near-normal lives, but frequent injections and/or blood transfusions may be required. In addition, some hemophilic patients are resistant to Factor VIII therapy but can be successfully treated using Factor VIIa replacement therapy. According to the World Health Organization, more than 400,000 people worldwide have hemophilia.
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
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