Study: hGH linked to PROLOR's CTP technology increases half-life, bioactivity

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).