PROLOR Biotech Reports Positive Preclinical Results in Weight Loss Study of Its Long-Acting Anti-Obesity Drug Candidate

NES-ZIONA, Israel, June 6, 2011 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH) today reported positive results from a comparative animal study of its long-acting anti-obesity drug candidate oxyntomodulin (OXY-RPEG).  The study measured the potential therapeutic effect of OXY-RPEG injected once or twice weekly as measured by weight loss and reduction in food intake compared with oxyntomodulin injected twice daily.  It was conducted using a state-of-the-art animal model specifically designed to test anti-obesity drugs.  In the study, OXY-RPEG injected either once or twice over a period of seven days demonstrated significantly higher weight loss, reduction of food intake and duration of weight loss activity compared with oxyntomodulin injected twice daily.  

Oxyntomodulin is a naturally occurring peptide hormone released by the digestive system that acts as a natural satiety signal to reduce food intake and increase energy expenditure following food ingestion.  Previous third-party studies in humans showed that oxyntomodulin can reduce appetite and food intake, leading to significant weight loss without apparent side effects.  However, as a result of oxyntomodulin's very short half-life, it had to be administered via three daily injections in these human studies.  PROLOR developed its longer-acting OXY-RPEG version by combining a naturally occurring oxyntomodulin with the company's proprietary Reversible PEGylation technology designed to increase the half-life of therapeutic peptides and small molecules.

In addition to the large reduction in required frequency and number of injections seen with OXY-RPEG in this preclinical study, OXY-RPEG also demonstrated greater potency, with the total dose administered over seven days containing approximately 15% of the cumulative dose of oxyntomodulin injected during the same period.

"We believe that oxyntomodulin's natural role as an appetite suppressant and its anticipated favorable safety profile make it a promising potential weight loss therapy for the millions of obese patients who currently lack safe and effective treatment options," said Dr. Abraham Havron, CEO of PROLOR.  "We are very encouraged that OXY-RPEG has demonstrated significant superiority to oxyntomodulin in weight loss, reduction in food intake, number and frequency of required injections and cumulative dose in this study in animals.  These results are especially promising because previous studies have shown a correlation between weight loss efficacy in animals and humans with oxyntomodulin.  We believe OXY-RPEG has the potential to become an important new treatment for obesity, and we are on track for initiating our first human clinical trial planned for 2012."

"We believe that this rigorous comparative preclinical study further validates our Reversible PEGylation technology as a promising platform for developing long-acting therapeutic peptides and small molecules," noted Shai Novik, President of PROLOR.  "These positive results provide us with the confidence to initiate additional Reversible PEGylation development initiatives for peptides and small molecules targeting high potential market segments."

ABOUT PROLOR

PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including its patented CTP technology and its Reversible PEGylation 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 the Reversible PEGylation technology is well-suited for use with peptides and small molecule therapeutics. PROLOR is currently developing long-acting versions of human growth hormone, which is in Phase II clinical development, and Factor IX, Factor VII, 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 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.