Navigation Links
PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.

PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting... -- NES-ZIONA, Israel, Aug. 24 /PRNewswire-FirstCall/ --

Advanced Search Search

  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Health Care & Hospitals, Medical Pharmaceuticals, Pharmaceuticals, Clinical Trials & Medical Discoveries, FDA Approval Click to view news release full screen  

PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.


NES-ZIONA, Israel, Aug. 24 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP.  The regulatory clearance followed PROLOR's submission of an Investigational New Drug (IND) application for hGH-CTP that included preclinical and Phase I clinical data, as well as plans for additional animal studies that the company intends to complete prior to initiation of Phase III trials. The hGH-CTP Phase II clinical program is currently ongoing in various clinical centers in Europe.  

"The FDA regulatory clearance for conducting a Phase II trial of hGH-CTP in the U.S. is an important milestone for PROLOR," said Dr. Abraham Havron, CEO of PROLOR. "This Phase II trial, which is underway at centers in a number of European countries, is an integral part of a comprehensive and coordinated clinical development program that has been carefully designed to generate the data that we anticipate will be necessary to obtain future marketing authorization in the U.S. and Europe, as well as in other localities.  We currently do not plan to include sites in the U.S. in this Phase II trial, but the FDA clearance helps ensure that we will be fully in sync with regulatory requirements in key territories, including the U.S., allowing us to utilize the hGH-CTP European Phase II program as the basis for our anticipated submission of applications to conduct Phase III trials in both the U.S. and Europe."

PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens.  The hGH-CTP Phase II clinical program follows a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.

The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone.  The trial is being conducted at up to 14 sites in six countries.  

ABOUT PROLOR BIOTECHPROLOR Biotech, Inc. is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, biobetter, 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 currently developing long-acting versions of human growth hormone, which is in clinical development, and interferon beta, factor VII, factor IX and erythropoietin, which are in preclinical development, as well as GLP-1 and other therapeutic peptides.  For more information on PROLOR, visit

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" 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.PROLOR CONTACT:

MEDIA CONTACT:Shai Novik, President

Barbara LindheimPROLOR Biotech, Inc.

GendeLLindheim BioCom PartnersTel: +1-866- 644-7811  


Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Bolder BioTechnology Announces $600,000 Grant from NIH to Study Long-Acting IL-11 Analog in Treating Acute Radiation Syndrome
2. Reportlinker Adds Global Pharma-biotech Alliance Analysis
3. Pharma ChemOutsourcing Show Seeking VCs to Address 100 Biotech Companies at September Event in Long Branch, NJ
4. Small, Smart, Stealth Nanoparticles Seek-and-Destroy Metastatic Cancers, as Epeius Biotechnologies Advances its Intellectual Property Estate With Additional U.S. Patents
5. Sangamo BioSciences Announces Nature Biotechnology Study Demonstrating the Use of Zinc Finger Nucleases to Generate HIV Resistant Human Stem Cells
6. Kun Run Biotechnology Announces That They Have Obtained the Manufacturing Approval for Entecavir from the China State Food and Drug Administration
7. Pharmaceutical and Biotech Executives Must Manage and Optimize Key Opinion Leaders or Fall Behind in the Marketplace
8. Groundbreaking Study Published in Nature Biotechnology Demonstrates Sensitivity of Single Molecule Test for Detection of Prostate Cancer
9. Spectros Corp. Enters Into Optical Biotechnology Patent Sale Agreement With Philips Electronics N.V.
10. Biotech Posts Weak Performance in April
11. US Oncology Meets With Leading Pharmaceutical and Biotech Companies to Design Clinical Trials for the Cancer Fighting Drugs of Tomorrow
Post Your Comments:
(Date:11/29/2015)... , Nov. 29, 2015  Strengthening its leadership in ... AEX: PHIA) today announced IntelliSpace Portal 8.0 , ... and visualization platform that helps radiologists detect, diagnose and ... 2015 Radiological Society of North America Annual Meeting (RSNA) ... Portal 8.0 helps address the changing demands in radiology ...
(Date:11/29/2015)... 29, 2015   Royal Philips  (NYSE: PHG, AEX: ... at the 2015 Radiological Society of North America Annual ... Place in Chicago . Visitors to ... company,s broad portfolio of integrated Diagnostic Imaging, Clinical Informatics, ... clinical performance, improve workflow and create a superior patient ...
(Date:11/29/2015)... Germany , Nov. 29, 2015  At ... invites attendees to experience the most complete mobile C-arm ... on display is Ziehm Vision RFD 3D, the world,s ... 16 cm edge length per scan volume. In addition, ... first fully motorized mobile C-arm in four axes which ...
Breaking Medicine Technology:
(Date:11/29/2015)... ... November 29, 2015 , ... ... the American Institute of Ultrasound in Medicine! , AIUM ultrasound practice accreditation ... they meet or exceed nationally recognized standards in the performance and interpretation ...
(Date:11/29/2015)... (PRWEB) , ... November 29, 2015 , ... "I struggled ... Things that as a Mother and Wife would love to do, I missed. We ... I just happened to call Dr. Zaidan first. They have changed my life drastically. ...
(Date:11/29/2015)... ... ... Cyber Monday deal is a deep 40% or more discount on every item on both ... skin care lover in your circle. Each Christmas, Sublime Beauty offers a special ... are staples: Collagen, Retinol and Hyaluronic Serums. , Stocking stuffers like Skin Brushes, natural Body ...
(Date:11/29/2015)... (PRWEB) , ... November 29, 2015 , ... NewsWatch featured ... technology products available to consumers. Amanda Forstrom, a technology expert and special reporter for ... be a reality in the future. , It’s the future because flying cars are ...
(Date:11/29/2015)... Ca (PRWEB) , ... November 29, 2015 , ... Khanna ... American Board of Ophthalmology on November 25th 2015. Peer Certification by the ... field of his specialty. Certification in Ophthalmology is first obtained after the completion of ...
Breaking Medicine News(10 mins):