PROLOR Biotech Announces Positive Preclinical Results From Long-Acting Factor IX Comparative Study

NES-ZIONA, Israel, Feb. 2, 2011 /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 IX (Factor IX-CTP) in Factor IX-depleted hemophilic mice. The study was designed to measure the potential increase in clotting activity and duration of therapeutic effect of PROLOR’s long-acting CTP-modified Factor IX when compared with commercially available recombinant Factor IX. Factor IX is indicated for the treatment of acute bleeding episodes and as therapy for prevention of bleeding in hemophilia B patients.

In the study, Factor IX-CTP, when compared with commercially available Factor IX, demonstrated a significantly longer duration of clotting activity in the hemophilic mice model. Bleeding episodes were also 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 and an 83% incidence of re-bleeding events for the untreated group.

The new study results support previous preclinical studies that demonstrated significant improvements in the half-life of Factor IX-CTP compared to commercially available Factor IX.

“We believe that this study further validates CTP as a leading platform for developing long-acting therapeutic proteins, demonstrating that the fundamental ability of CTP to extend duration of therapeutic effect while increasing biological activity is consistent across various types of proteins,” noted Shai Novik, President of PROLOR. “The utility of CTP has previously been validated for non-enzyme proteins, such as Merck’s hormone therapy Elonva® and PROLOR’s human growth hormone, interferon beta and erythropoietin. With this successful Factor IX study, we have now additionally confirmed the applicability of CTP technology for the development of biobetter enzymes.”

“We believe there is great need among hemophilia patients and their physicians for therapies that will provide prolonged protection from bleeding,” said Dr. Abraham Havron, CEO of PROLOR. “The encouraging efficacy seen in our preclinical hemophilia study, together with the impressive half-life extension seen in our previous studies, show that Factor IX-CTP may be able to reduce the number of injections needed by hemophilia B patients to once-weekly or less.”

Dr. Havron added, “We believe that these results further confirm the clinical potential of Factor IX-CTP to become an important long-acting therapy for the treatment of acute bleeding episodes and for prevention of bleeding in hemophilia B patients. We are moving forward with our plan to initiate our first clinical study of Factor IX-CTP in hemophilia in early 2012.”

About Hemophilia and Hemophilia B

Hemophilia is a group of hereditarygenetic disorders that impair the body’s ability to control blood clotting or coagulation. People with hemophilia do not produce adequate amounts of Factor VIII or Factor IX protein, which are necessary for effective blood clotting. In severe hemophiliacs even a minor injury can result in blood loss lasting 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 have hemophilia, corresponding to an incidence of 15 to 20 in every 100,000 males born worldwide. Hemophilia B is associated with inadequate Factor IX and occurs at an incidence of about 1 in 20,00034,000 male births. Hemophilia B is largely an inherited disorder but in approximately 30% of cases, there is no family history and the condition is the result of a spontaneous gene mutation. The availability of recombinant Factor VIII and Factor IX has enabled many hemophiliacs to live near-normal lives, but frequent injections are required.

ABOUT PROLOR BIOTECH

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, and PROLOR is currently developing long-acting versions of human growth hormone, which is in Phase II clinical development, and Factor VII, Factor IX, interferon beta and erythropoietin, which are in preclinical development, as well as an anti-obesity peptide and agents for atherosclerosis and rheumatoid arthritis. 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.