NES-ZIONA, Israel, April 8, 2013 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that it received a notice of allowance from the U.S. Patent and Trademark Office for a new patent application covering the company's proprietary long-acting CTP-enhanced coagulation factors for the treatment of hemophilia: Factor VIIa-CTP, Factor Vll-CTP and Factor IX-CTP. The allowed claims cover both product composition and treatment methods.
"This new patent allowance is important for PROLOR, as we move forward with plans to initiate a Phase II clinical study of our long-acting Factor VIIa-CTP in early 2014," said Shai Novik, President of PROLOR. "Our intellectual property strategy is designed to provide multiple layers of protection for our product portfolio, and we believe that this new patent will provide additional reinforcement to our existing patent estate for our hemophilia drug candidates."
PROLOR previously presented preclinical data on its long-acting versions of factor Vlla and factor IX. In hemophilic mice, Factor VIIa-CTP demonstrated superior performance on multiple parameters and resulted in greater survival of the subjects compared to commercially available factor VIIa. Factor VIIa-CTP also demonstrated the potential for subcutaneous administration in addition to administration using standard IV dosing. Factor IX-CTP demonstrated significantly longer duration of clotting activity in hemophilic mice, and bleeding episodes were significantly shorter and less intense compared with commercially available factor IX. None of the animals treated with Factor IX-CTP had any spontaneous re-occurring bleeding events, as compared with a 50% incidence of re-bleeding events for the group treated with commercially available factor IX.
The new patent is expected to issue in the next few months.
PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including 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 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, all of which are in preclinical development. For more information, visit http://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.