PROLOR Biotech, Inc. announced that it has received a notice of allowance from the US Patent and Trademark Office (USPTO) for a patent application covering PROLOR’s CTP-modified interferons. Interferons are proteins produced in response to the presence of tumour cells or pathogens, such as viruses, bacteria and parasites.
Several interferon proteins, including interferon alfa and beta, are used as therapies for hepatitis B and C virus infections, multiple sclerosis and haematological malignancies, such as leukaemia and lymphomas. The estimated worldwide market for interferons is approximately $8 billion.
“We are very pleased with the growing number of new patent allowances PROLOR has received for specific CTP-modified compounds and for our CTP platform technology. Once issued, these allowances should strengthen the intellectual property portfolio that we are creating around our CTP technology, and we believe they will serve as an important value driver for PROLOR going forward,” commented Shai Novik, president of PROLOR.
This new US patent is expected to be issued in the next few months.
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 show 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 CTPenhanced fertility drug Elonva (FSH-CTP) in 2010. A single Elonva injection replaces a week-long regimen of seven daily FSH injections. PROLOR recently announced interim efficacy results from a phase II trial of its CTP-modified human growth hormone (hGH-CTP) in growth hormone deficient adults, showing 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 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.