CARMIEL, Israel I December 22, 2016 I Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (PLX), announced today that the last patient has been enrolled in the Company’s phase II clinical trial of AIR DNaseTM  (PRX-110) for the treatment of Cystic Fibrosis (CF).  The Company expects to report interim top-line results from this study during the first week of January 2017, and full results before the end of the first quarter of 2017.

AIR DNase is a plant cell-derived recombinant form of human deoxyribonuclease I (DNase I) that the Company has designed, through chemical modification, to be resistant to inhibition by actin.  Given actin is a potent inhibitor of DNase I activity, the Company’s AIR DNase has the potential to enhance the enzyme’s efficacy significantly in CF patients when compared to the currently approved DNase treatment (Pulmozyme®).

The phase II trial is a 28-day switch-over study of 15 CF patients previously treated with Pulmozyme® to evaluate the efficacy and safety of AIR DNase in CF patients.  Patients that have participated in the trial have undergone a two-week washout period, in which they were not treated with Pulmozyme, before dosing with the Company’s AIR DNase.  The main efficacy endpoint is the change of forced expiratory volume (FEV1) and forced vital capacity (FVC).  Additional endpoints include safety and tolerability, immunogenicity and pharmacokinetic data. In the trial, AIR DNase is administered through Philips Respironics’ I-neb AAD Inhaler System, for which the Company has a supply agreement for the exclusive use of the device for the development of an inhaled product based on dornase alfa for the treatment of CF.  The I-neb AAD is a small, lightweight, virtually silent device that is fully portable and has a unique vibrating mesh technology that allows for faster administration than conventional jet or ultrasonic nebulizers.

“We believe that our unique enzyme modification, which allows the enzyme to resist actin inhibition, could translate into favorable improvement in FEV1 parameter, compared to those experienced to date, and could be of great help to CF patients coping with this devastating disease.  In addition to PRX-110, we have two other product candidates currently in clinical trials in patients; PRX-102 for the treatment of Fabry disease and OPRX-106, a first in the world oral enzyme in development for the treatment of ulcerative colitis.  We are excited about these product candidates as they are both specifically designed to be superior to existing products, with the potential to garner significant market share in their respective categories.”

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®.  Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.  Protalix’s development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; PRX-110, a chemically modified DNase I for the treatment of Cystic Fibrosis; and others.

SOURCE: Protalix BioTherapeutics