Data From Phase II Trial of Prolor Biotech's Long-acting Human Growth Hormone Presented at Endo 2012
Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient Adults Presented in Oral Session at the 94th Annual Meeting of the Endocrine Society
HOUSTON and NES-ZIONA, Israel, June 26, 2012 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH) today reported that researchers at ENDO 2012 presented data from the company's Phase II trial of its long acting human growth hormone, hGH-CTP, in growth hormone deficient adults. The data, which were previously reported by the company, confirm that hGH-CTP has the potential to be administered once weekly to adults with growth hormone deficiency and that it appears to be safe and well tolerated. The hGH-CTP data were discussed in an oral presentation at ENDO 2012, the 94th Annual Meeting and Expo of the Endocrine Society, which is being held in Houston Texas June 23-26, 2012.
"ENDO 2012 represents a great opportunity to share the encouraging data we have reported from our completed Phase II trial of hGH-CTP with leading endocrinologists from North America and around the world," noted Dr. Abraham Havron, CEO of PROLOR Biotech. "These data further confirm the potential of our long acting version of human growth hormone to be administered once-weekly, in contrast to the daily injections currently required. We believe that informing the broader endocrinology community about our progress with hGH-CTP is timely as we continue to enroll subjects in our Phase II trial in growth hormone deficient children and prepare to initiate a Phase III trial in growth hormone deficient adults, expected later this year."
The data presented at ENDO 2012 included results from the main component of the Phase II trial, which administered hGH-CTP to growth hormone deficient adults for four weeks, as well as top-line results from a four-month treatment extension study of hGH-CTP in a similar population. As reported last month, these data reaffirm the company's prior Phase II findings showing that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone, and they further validate the dosing regimen for the company's planned Phase III trial.
The study, Once-Weekly, CTP-Modified hGH (MOD-4023) Is Effective in Growth Hormone Deficient Adults: A Phase II Dose and Frequency Finding Study, was discussed in an oral presentation on June 25, 2012 by clinical investigators who oversaw the Phase II trial. For more information on ENDO 2012, visit www.endo-society.org/endo.
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, 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.
Shai Novik, President Barbara Lindheim
PROLOR Biotech, Inc. BLL Partners, LLC
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SOURCE PROLOR Biotech, Inc.
Web Site: http://www.endo-society.org/endo
Posted: June 2012