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PROLOR Biotech Announces Initiation Of Phase I Clinical Trial For Its Long-Acting Growth Hormone

September 22, 2009

PROLOR Biotech, Inc. (OTC Bulletin Board: PBTH) formerly Modigene Inc., announced the initiation of a Phase I clinical trial of its long-acting human extension hormone drug solicitant hGH-CTP.

hGH-CTP is being developed to provide growth hormone deficient adults and children by dint of. the option to replace the multiple injections per week that are currently required with a once-weekly or bi-monthly injection. The initiation of the trial follows a successful safety and immunogenicity study of hGH-CTP in primates and regulatory approvals by the agency of the IRB committee of the Tel-Aviv Medical Center and the Israeli Ministry of Health.

The Phase I woe is a randomized, double-blinded, placebo-controlled, single-dose, dose-escalating study to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic properties of hGH-CTP in 24 of a sound constitution volunteers. It will exist conducted at the Early-Phase Clinical Pharmacology Unit located at the Tel-Aviv Medical Center.

“The initiation of a Phase I clinical endeavor of our long-acting hGH-CTP represents an important milestone for PROLOR,” said Dr. Avri Havron, CEO of PROLOR. “We were delighted with the results of our hGH-CTP studies in primates, which showed that hGH-CTP had an excellent half-life and biological activity and was safe at all doses tested without any one signs of immunogenicity. We are at this moment eager to obtain data adhering its bioactivity in humans.”

Dr. Havron continued, “This trial is being conducted at the Early-Phase Clinical Pharmacology Unit at the Tel-Aviv Sourasky Medical Center, a top-notch facility that has a successful footmark record of conducting more than 250 clinical studies for leading global pharmaceutical and biotech companies in a kind of clinical areas. We look forward to completing the Phase I trial in such a manner that we can move ahead with the further clinical progress to maturity of hGH-CTP.”

ABOUT hGH-CTP

hGH-CTP is PROLOR’s see preprinter long-acting version of like a human being growth hormone. hGH is used for the long-term treatment of children and adults with growth failure due to inadequate secretion of endogenous growth hormone. It is also sometimes used to counter involuntary load down deprivation and certain material manifestations of aging. Patients currently using hGH must inject the medicine betwixt two and seven times each week. In exhibition of differences, hGH-CTP is expected to require only weekly or bi-monthly injections. In 2007 the yearly report market according to hGH was estimated at $2.5 billion.

ABOUT CTP

PROLOR’s CTP technology is based on some amino acid sequence that occurs naturally in humans, the carboxyl termination peptide. When attached to a therapeutic protein, CTP extends the time that the protein is active in the material part. The potential profit of the technology has been demonstrated by Schering-Plough, what one. in 2009 announced prosperous facts from its Phase III ENGAGE trial demonstrating that women receiving a single injection of the productiveness drug FSH-CTP achieved the same pregnancy rates as women receiving seven consecutive quotidian injections of engaged in traffic FSH. This 1,509 patient trial formed the basis for a Marketing Authorization Application by Schering-Plough that is currently under review through the European Medicines Agency. PROLOR is using the like CTP technology to extend the duration of exercise of human growth hormone and other therapeutic proteins. It has an aristocratic license from Washington University in St. Louis to the CTP technology for use through every part of curative proteins omit as antidote to the four fertility hormones licensed to Schering-Plough.

ABOUT PROLOR BIOTECH

PROLOR Biotech, Inc. is a 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 generally developing long-acting versions of human growth hormone, which recently entered Phase I clinical trials, and interferon beta and erythropoietin, which are in late preclinical unravelling, to the degree that well as GLP-1.

Safe Harbor Statement: This press release contains forward-looking statements, 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 twist together risks and uncertainties that may affect PROLOR’sitting business and prospects, including the risks that PROLOR may not succeed in 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 exhibition may fall short, may not achieve the expected results or effectiveness and/or may not cause data that would favor the approval or marketing of these products toward the indications vital principle studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of somewhat grants from the OCS is problematical and is subject to management changes of the Israeli commonwealth, and that such grants may be insufficient to assist with product expansion; and other risks and uncertainties that may cause results to differ importantly from those set forth in the forward-looking statements. The increase of any products using the CTP platform technology could also be affected by a enumerate of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements instead of given conditions analyses and decision making, the striking 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 part 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.

Source: PROLOR Biotech, Inc

Written by Samanta · Filed Under Pharmacy Industry News