PROLOR Biotech, Inc. has received a notice of allowance from the US Patent and Trademark Office (US PTO) for a new patent application covering the company's long-acting CTP-enhanced human growth hormone (hGH-CTP).  Upon issuance, the new patent would provide PROLOR with additional intellectual property protection covering methods for the induction of growth in growth hormone deficient patients. This new US patent is expected to issue in the next few months.

This new patent is the fourth hGH-CTP patent that has been allowed by the USPTO. The expanding hGH-CTP patent estate is expected to provide additional protection for PROLOR's hGH-CTP compound, in addition to a number of CTP platform patents that have already issued.

"Upon issuance, this new hGH-CTP patent will be a significant addition to PROLOR's intellectual property portfolio," said Shai Novik, president of PROLOR. "We have several other CTP-related patent applications that are currently pending, and we believe that this growing patent portfolio will reinforce our existing patent estate for our CTP-enhanced compounds in development, as well as for our CTP platform technology generally."

Previously reported data from the company's phase II trial of hGH-CTP in growth hormone deficient adults showed that a single weekly injection has 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.  In this trial, hGH-CTP demonstrated a good safety and tolerability profile. A phase II trial in growth hormone deficient children is currently enrolling patients.

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 show 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.