PROLOR Biotech Receives Notice of Allowance for New U.S. Patent Covering Broad Applications of its CTP Platform for Long Acting Therapeutic Proteins
NES-ZIONA, Israel, Jan. 7, 2013 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that it received a notice of allowance from the U.S. Patent and Trademark Office for a patent application covering the company's CTP platform, which has the potential to extend the duration of activity of therapeutic proteins. The allowed claims cover manufacturing methods for CTP-modified compositions of a wide array of classes of therapeutic proteins, including hormones, high affinity protein ligands, proteins that induce or regulate an immune response, proteins involved with autocrine and paracrine activities, and mimetics of these therapeutic proteins, as well as other types of proteins.
This new U.S. patent is expected to be issued in the next few months.
"Upon issuance, this new patent is expected to further strengthen PROLOR's expanding intellectual property portfolio covering the CTP platform, as well as the new products we are developing using this versatile technology," said Shai Novik, president of PROLOR.
About PROLOR's CTP Technology
PROLOR's CTP technology is based on the naturally-occurring human carboxyl terminal peptide (CTP). When attached to a therapeutic protein, CTP significantly extends the length of time the protein remains active in the body. Clinical and preclinical studies have shown that the CTP technology appears to be safe and effective in extending the duration of all proteins tested to date. CTP's safety and efficacy have also been validated by the marketing approval of Merck's long-acting CTP-enhanced fertility drug Elonva® (FSH-CTP). A single Elonva injection replaces a regimen of seven daily FSH injections. Results from a Phase II trial of PROLOR's CTP-modified human growth hormone (hGH-CTP) in growth hormone deficient adults showed that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone. CTP was identified by researchers at Washington University in St. Louis and is exclusively licensed to PROLOR for all proteins and peptides, except for four endocrine proteins that are licensed to Merck. CTP is manufactured using standard industrial biotech processes.
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 http://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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