Study Published in the Journal Endocrinology Further Confirms Therapeutic Potential of PROLOR's Long-Acting Human Growth Hormone

NES-ZIONA, Israel, Aug. 2 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today reported publication of a preclinical study in the current on-line edition of the journal Endocrinology showing that human growth hormone (hGH) linked to PROLOR's carboxyl terminal peptide (CTP) technology has significantly increased half-life and bioactivity compared to commercially available hGH.  The publication, which is authored by PROLOR researchers, will also be included in the September print edition of Endocrinology.

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.  PROLOR recently initiated a Phase II clinical trial of hGH-CTP, following 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 publication of this study in Endocrinology, considered to be one of the most authoritative biomedical research journals in the world, further validates the growing body of clinical and preclinical data supporting the ability of CTP technology to significantly extend the half-life and duration of action of therapeutic proteins," said Dr. Fuad Fares, lead author of the study and Chief Scientific Officer of PROLOR.  "Therapeutic proteins are increasingly important treatments for a variety of diseases, and we believe the demonstrated ability of CTP technology to reduce the frequency of required injections could provide important benefits to the many patients who depend on these drugs.  We look forward to completing the ongoing Phase II trial of hGH-CTP and anticipate initiating Phase III studies during 2011."

The publication is currently available on-line at: http://endo.endojournals.org/cgi/content/abstract/en.2009-1431v1.  It will be published in the September print edition of Endocrinology as "Designing a Long-Acting Human Growth Hormone (hGH) by Fusing the Carboxyl-Terminal Peptide of Human Chorionic Gonadotropin Subunit to the Coding Sequence of hGH," Fuad Fares, Rachel Guy, Ahuva Bar-Ilan, Yana Felikman, and Eyal Fima, Endocrinology, September 2010.151(9).  

ABOUT PROLOR'S hGH-CTP PHASE II CLINICAL TRIAL

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 THE JOURNAL ENDOCRINOLOGY

Endocrinology has defined the science of endocrinology for most of the twentieth century. One of the most authoritative biomedical research journals in the world, it publishes 6,000 pages annually of the highest quality original work ranging from subcellular mechanisms to whole animal physiology. Topics include bone and mineral; growth factors; reproductive/steroids; neuroendocrinology/signal transduction; thyroid; and physiology. The low manuscript acceptance rate of 30% reflects the degree to which it is committed to the highest scientific standard.

ABOUT PROLOR BIOTECH

PROLOR 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 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" 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 Lindheim

PROLOR Biotech, Inc.

GendeLLindheim BioCom Partners

Tel: +1 866 644-7811

+1 212 918-4650

Email: [email protected]




SOURCE PROLOR Biotech, Inc.

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