NES-ZIONA, Israel, Feb. 14, 2012 /PRNewswire/ -- 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."
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.
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.
SOURCE PROLOR Biotech, Inc.