Protalix BioTherapeutics, Inc. announced positive interim results from the Company’s phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis (CF) for the first 13 CF patients enrolled in the study.  Fifteen patients have been enrolled in, and are expected to complete, the study.  alidornase alfa is a plant cell expressed, chemically modified recombinant DNase enzyme resistant to inhibition by actin, which the Company has specifically designed to enhance the enzyme’s efficacy in CF patients. The phase II trial is a 28-day switch-over study to evaluate the safety and efficacy of alidornase alfa in CF patients previously treated with Pulmozyme®.  Participation in the trial is preceded by a two-week washout period from Pulmozyme® before treatment with alidornase alfa via inhalation.  The initial primary efficacy result shows that alidornase alfa improves lung function as demonstrated by a mean absolute increase in the percent predicted forced expiratory volume in one second (ppFEV1) of 4.1 points from baseline.  A commercially available small molecule CFTR modulator for the treatment of CF has reported a mean absolute increase in ppFEV1 of 2.5 from baseline in its registration clinical study.  This score was achieved while 74% of the patients participating in the trial of the CFTR modulator were also treated with Pulmozyme® on top of the modulator.  While this marketed CFTR addresses a certain mutation applicable to less than 50% of CF patients, alidornase alfa is being developed to treat all CF patients. Sputa available DNA samples were analyzed for approximately half of the patients.  A mean reduction of approximately 60% in DNA content from baseline was observed, and a mean reduction of approximately 90% from baseline was observed for sputa visco-elasticity.  This data provides further supportive evidence of improved lung function after treatment with alidornase alfa, as demonstrated by the increase in ppFEV1. No serious adverse events were reported, and all adverse events that occurred during the study were mild and transient in nature.