PROLOR Biotech Announces Positive Results From Preclinical Toxicology Study Of Its Reversible-Pegylation Platform Technology
—Supports Potential of RPeg Technology to Safely Increase Duration of Broad Range of Peptide and Small Molecule Drugs—
—Positive Toxicology Results Are Important Milestone as Company Prepares to Advance MOD-6030 into Clinical Trials Scheduled for 2013—
NES-ZIONA, Israel, Oct. 16, 2012 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced positive results from a preclinical toxicology study designed to assess the safety and tolerability of PROLOR's proprietary long-acting reversible-pegylation technology ("RPeg"). The study results demonstrate that RPeg was safe and well-tolerated at high doses following repeated administration in rats.
The RPeg platform has been utilized to develop PROLOR's preclinical drug candidate MOD-6030, a GLP-1/Glucagon dual receptor agonist peptide in development for the dual indications of obesity and type 2 diabetes. RPeg can also potentially be applied to a range of peptide and small molecule drugs to increase their duration of action, and it is expected to be especially well suited for use with drugs that must cross the blood-brain barrier.
"The positive results of this toxicology study are an important milestone as PROLOR continues the preclinical development of MOD-6030, which is expected to enter clinical trials next year," noted Shai Novik, President of PROLOR. "These results also add to the positive preclinical safety data supporting the use of RPeg as a safe and well-tolerated platform for the development of a broad range of long-acting peptides and small molecule drugs. We intend to apply RPeg to internal projects and also to share these data with potential partners whose drug candidates may benefit from this promising technology."
PROLOR is using its RPeg technology to develop long-acting therapeutic peptides and small molecules. RPeg's expected key competitive advantage is its unique ability to enable development of long-acting drugs that target the brain and that therefore must penetrate the blood-brain barrier. The RPeg technology has been shown in animal models to significantly enhance the half-life and improve the biological activity of a variety of peptides and small molecules, including compounds that need to cross the blood-brain barrier, such as the appetite suppressant peptide PYY and PROLOR's dual action drug candidate MOD-6030, as well as the diabetes-related compound exendin-4, the blood pressure controlling hormone ANP and the intravenous antibiotic drug gentamicin.
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.