PROLOR Biotech Initiates Phase II Trial of its Long-Acting Human Growth Hormone in Children with Growth Hormone Deficiency
NES-ZIONA, Israel, March 20, 2012 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced initiation of a Phase II clinical trial of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in children with growth hormone deficiency.
The pediatric trial follows successful completion of a Phase II trial of hGH-CTP in growth hormone deficient adults, which demonstrated that hGH-CTP was safe and well tolerated with 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. A subsequent pilot study suggested that bi-monthly dosing of hGH-CTP may also be feasible.
Growth hormone deficiency (GHD) in children occurs when the pituitary gland fails to secrete adequate amounts of growth hormone. Growth hormone replacement therapy may enable a GHD child to reach a normal height, but the therapy requires daily injections and may require a total of more than 3,000 injections before the child reaches the age of 18.
"Obtaining regulatory clearance for a clinical trial in children is a challenge for any drug developer. We believe that our receipt of regulatory clearance for the initiation of our Phase II study in growth hormone deficient children is another indicator of the quality of our hGH-CTP program," said Dr. Abraham Havron, CEO of PROLOR.
Dr. Havron continued, "Our Phase II pediatric study is designed to provide information about the effectiveness and safety of a range of doses of hGH-CTP for a single weekly injection regimen in pediatric patients. We look forward to advancing our comprehensive clinical program for hGH-CTP in 2012, including this Phase II pediatric trial and an anticipated Phase III trial in growth hormone deficient adults that is targeted for later this year."
The pediatric hGH-CTP 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 will compare the 12-month growth velocity of children receiving certain doses of hGH-CTP, injected once weekly, or commercial hGH injected daily, which is the current standard of care. The trial is expected to take place at up to 35 sites in 12 countries.
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. PROLOR is currently developing a long-acting version of human growth hormone, which has 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, as well as agents for atherosclerosis and rheumatoid arthritis, which are all 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.
SOURCE PROLOR Biotech, Inc.
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