LEIPZIG, Germany and NES-ZIONA, Israel, Sept. 21, 2012 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that data from the company's Phase II trial of hGH-CTP, its long acting human growth hormone, in growth hormone deficient adults will be presented at ESPE 2012, the 51st Annual Meeting of the European Society for Paediatric Endocrinology.
The previously reported data confirmed that a single weekly injection of hGH-CTP has the potential to reduce the required dosing frequency of human growth hormone from the current standard of one injection per day to a single weekly injection. In this trial, hGH-CTP demonstrated a good safety and tolerability profile. In addition, the study showed that only 50-65% of the cumulative weekly dose of conventional human growth hormone was required for the majority of the patients to remain within the normal range of IGF-1, a key biomarker of growth hormone activity. The safety profile of hGH-CTP in this trial was further enhanced by the finding that it did not cause excessive IGF-1 levels in patients, nor was any IGF-I accumulation observed.
The positive Phase II data in adults were instrumental in PROLOR's decision to proceed with a Phase II hGH-CTP trial in growth hormone deficient children that is currently enrolling patients. The pediatric Phase II trial is a randomized, open-label, dose-finding study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected weekly in children with growth hormone deficiency. The trial is comparing the 12-month growth velocity of children receiving hGH-CTP injected once weekly with those receiving commercially available hGH injected daily.
"Growth hormone replacement therapy may enable a growth hormone deficient child to reach a normal height, but it currently involves daily dosing that may total more than 3,000 injections before the child reaches the age of 18," said Dr. Abraham Havron, CEO of PROLOR. "hGH-CTP has the potential to dramatically reduce this number, thereby making growth hormone therapy less burdensome and more feasible. We welcome the opportunity to raise awareness of our progress with hGH-CTP at this meeting of pediatric endocrinology opinion leaders."
Poster P1-d3-296, Once-Weekly, CTP-Modified hGH (MOD-4023) Effectively Maintains IGF-1 Levels Within the Normal Range in Growth Hormone Deficient Adults, Supporting Initiation of Clinical Development in Children, will be presented during the September 22, 2012 poster session of ESPE 2012, which is being held September 20-23, 2012 in Leipzig, Germany. For more information, visit http://www.espe2012.org/.
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 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.PROLOR CONTACT: MEDIA CONTACT:Shai Novik, President Barbara LindheimPROLOR Biotech, Inc.
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