Protalix Biotherapeutics Inc (NYSEMKT:PLX) reported that Phase II trial report, including clinical data for alidornase alfa for the treatment of Cystic Fibrosis will be covered in an oral presentation at the European Cystic Fibrosis Society Meeting in Seville. Alidornase alfa is a crop cell-expressed, chemically-changed recombinant DNase 1 enzyme resistant to reserve by actin, which the firm has specifically intended to improve the enzyme’s efficacy in CF subjects.
The oral presentation will be done by Professor Eitan Kerem, the key investigator of the clinical study as a part of a workshop focusing on the airway surface, inflammation and mucus – new treatments. An archived copy of this presentation will be accessible following the conference at company’s site on the presentations tab of the shareholders’ page.
The Phase II study of Protalix is a 28-day switchover trial to assess the efficacy and safety of alidornase alfa in CF subjects previously treated with Pulmozyme®, currently the single commercially available DNase 1 therapy for CF. Participation in the study was preceded by a 2-week washout era from Pulmozyme® before cure with alidornase alfa through inhalation. Sixteen subjects were registered in the trial, all of whom closed the study.
In accordance with the study design, each participating subject was assessed at three key time-points during the trial for percent expected forced expiratory volume in single second, or ppFEV1, a major efficacy measure. The initial ppFEV1 test was done at screening, when the subject was still being cured with Pulmozyme®.
Next ppFEV1 test was done after the patient witnessed a 2-week washout time from Pulmozyme® but before initial inhalation with alidornase alfa, the baseline, while the third ppFEV1 assessment was performed at the close of the 28-day trial after the patient faced daily inhalation therapies of alidornase alfa. Protalix reported that final assessment of the data showed a mean absolute jump in ppFEV1 from baseline.