JERUSALEM (dpa-AFX) - Protalix BioTherapeutics Inc. (PLX) announced the first patient has been dosed in the Company's phase II clinical trial of AIR DNaseTM (PRX-110) for the treatment of Cystic Fibrosis (CF). 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. The patients will undergo a two-week washout period, in which they will not be treated with Pulmozyme, before dosing with the Company's AIR DNase.
The main efficacy endpoint is the change from baseline of forced expiratory volume (FEV1) and forced vital capacity (FVC). Additional endpoints include safety and tolerability, immunogenicity and pharmacokinetic data.
The Company has signed a supply agreement with Philips Respironics for its I-neb AAD Inhaler System which gives the Company exclusive use of the device for the development of an inhaled product based on dornase alfa for the treatment of CF, and the Company is using the device to deliver AIR DNase in the clinical trial.
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.
The phase II clinical trial is expected to complete enrollment in the second half of 2016. Top-line results are expected to be available around year-end.
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