PROLOR Biotech Announces Positive Preclinical Results From Comparative Study of Its Long-Acting Clotting Factor VIIa

NES-ZIONA, Israel, Sept. 15, 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 VIIa (Factor VIIa-CTP) in hemophilic mice.  The study was designed to measure the potential increase in half-life and clotting activity of PROLOR's long-acting CTP-modified Factor VIIa when compared with commercially available recombinant Factor VIIa.  Factor VIIa is indicated for the treatment of acute bleeding episodes and as therapy for prevention of bleeding in hemophilia A and hemophilia B patients who have developed inhibitors against treatment with either Factor VIII or Factor IX.

In the preclinical study, Factor VIIa-CTP, when compared with commercially available Factor VIIa, demonstrated a significantly longer half-life and duration of clotting activity in the hemophilic mice model.  

"We believe the results of our first Factor VIIa-CTP preclinical study are very promising and they are consistent with the results we obtained from a preclinical study of our other blood coagulant agent in development, clotting Factor IX-CTP, which we reported earlier this year also demonstrated significant potential in animal models of hemophilia," noted Shai Novik, President of PROLOR.  "With the positive results from this Factor VIIa-CTP study, we now have what we believe are two highly competitive coagulation therapies in development that address a target market estimated at approximately $2 billion."

"We believe 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 study show that Factor VIIa-CTP may be able to offer an improved therapeutic option to the many hemophilia patients who are not well protected by current therapies."

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.  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 levels of Factor IX and occurs at an incidence of about 1 in 20,000–34,000 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.  Commercially available recombinant Factor VIII, Factor VIIa and Factor IX have enabled many hemophiliacs to live near-normal lives, but frequent injections and/or blood transfusions may be 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 VIIa, 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.

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