Clinical Development Plan for Pediatric Use of PROLOR Biotech's Long-Acting Human Growth Hormone has Been Accepted for Review by European Medicines Agency
Published: Jun 20, 2011
NES-ZIONA, Israel, June 20, 2011 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), today announced that its paediatric investigation plan for clinical development of its long-acting human growth hormone (hGH-CTP) has been accepted for review by the Paediatric Committee of the European Medicines Agency (EMA). Following promising efficacy and safety interim results in its ongoing Phase II trial of hGH-CTP in growth hormone-deficient adults, PROLOR is now actively pursuing development of hGH-CTP for the treatment of growth hormone-deficient children.
Last April, PROLOR announced positive interim efficacy results from its Phase II trial of hGH-CTP in adults. The interim efficacy data showed 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. These positive interim data followed 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.
In the European Union, a company submitting a first-time Marketing Authorization Application (MAA) to the EMA for a new drug product must have in place an approved paediatric investigation plan (PIP) detailing both the timelines for development and special measures that will be taken when developing the drug for children, even if the first submission is for use in adult populations. If an approved PIP is not in place, the EMA will not approve the MAA for use in adults.
"As we advance hGH-CTP towards Phase III, we are committed to proactively addressing all of the requirements for ensuring the rapid progress of the clinical and regulatory program needed for approval of hGH-CTP in growth hormone-deficient adults," said Shai Novik, president of PROLOR. "The EMA's acceptance of our PIP for review is a positive development for the current clinical program and is also an important early milestone in our plans to develop hGH-CTP for growth hormone-deficient children, a population in which a longer-acting hGH requiring fewer injections is expected to have large clinical and commercial potential."
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, anti-obesity peptide OXY-RPEG and erythropoietin, which are in preclinical development, as well as agents for atherosclerosis and rheumatoid arthritis. 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
PROLOR Biotech, Inc.
GendeLLindheim BioCom Partners
Tel: +1 866 644-7811
+1 212 918-4650
SOURCE PROLOR Biotech, Inc.