PROLOR Biotech Announces Positive Interim Results From Phase II Trial of its Long-Acting Human Growth Hormone
- Data from Initial "Low-Dosing" Cohorts in the Trial Show a
Single hGH-CTP Injection Has Potential to Replace Seven Consecutive
Daily Injections of Currently Marketed Human Growth Hormone -
- Enrollment in All Study Cohorts Is Continuing with Phase II Trial Expected To Be Completed as Planned by Mid-Year -
NES-ZIONA, Israel, April 11, 2011 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH) today reported positive interim efficacy results from a Phase II clinical trial of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults. The interim efficacy data show that a single weekly injection of hGH-CTP, even when administered at relatively low doses, has the potential to replace seven consecutive daily injections of currently marketed human growth hormone (hGH). These positive interim data follow PROLOR's announcement in February that hGH-CTP has demonstrated a good safety profile in the Phase II trial, as confirmed in a review of interim data by the independent Data and Safety Monitoring Board.
The objective of the randomized open-label, multicenter Phase II trial is to measure the safety and tolerability of hGH-CTP and to assess dose ranging and dose response. The trial is enrolling up to 56 growth hormone deficient adults allocated among several dosing cohorts.
The three main cohorts in the trial are receiving a single weekly dose of hGH-CTP, containing 30%, 45% or 100% of the cumulative commercial hGH dose these patients would usually inject each day over the course of seven days (referred to as the "30%, "45%" and "100%" cohorts, respectively.) The interim efficacy data reflect initial results from 34 patients, all of whom were enrolled in "low-dosing" cohorts.
In addition to the three main cohorts, PROLOR researchers are also enrolling growth hormone deficient adults in an experimental fourth cohort. The patients in the experimental fourth cohort are receiving a single injection of hGH-CTP once every two weeks that contains 50% of the cumulative commercial dose of hGH that they would usually inject each day during a two-week period.
Efficacy in the trial for the cohorts receiving a single weekly injection of hGH-CTP is defined by measuring whether these growth hormone deficient adults can maintain insulin-like growth factor 1 (IGF-1) levels within the desired therapeutic range over a period of seven days. The interim results from the "low-dosing" 30% and 45% cohorts suggest that this efficacy endpoint is achievable -- a single weekly injection of hGH-CTP in growth hormone deficient adults has the potential to maintain IGF-1 levels within this target range for at least seven days, thereby potentially enabling these patients to replace their current regimen of seven consecutive daily injections of hGH with a single injection of hGH-CTP.
"We are very encouraged by these interim results from our hGH-CTP Phase II clinical trial," noted Dr. Avri Havron, CEO of PROLOR. "They show that single weekly injections of hGH-CTP appear to work well in adults with growth hormone deficiency, even when given at low doses."
Dr. Havron added, "We expect to complete this Phase II trial around mid-year. Based on these promising interim data, we are increasingly confident that the Phase II trial will provide sufficient information to enable our researchers to establish the most suitable doses of hGH-CTP for our planned Phase III registration trial in adults with growth hormone deficiency."
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, and PROLOR is currently developing long-acting versions of human growth hormone, which is in Phase II clinical development, as well as Factor VII, Factor IX, interferon beta, erythropoietin, an anti-obesity peptide and 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.
Posted: April 2011