Protalix Biotherapeutics Inc (NYSEMKT:PLX) demonstrates that its up move still can continue in coming period. Shares are up on nearly a 5x increase in volume. The party commenced in early January when the firm reported positive initial report from a mid-stage trial evaluating AIR DNase in cystic fibrosis patients. Stock price has almost tripled since then.
Protalix reported positive interim report from the firm’s phase II clinical study of alidornase alfa for the cure of Cystic Fibrosis for the first 13 CF subjects registered in the study. As many as 15 subjects have been registered, and are anticipated to complete, the trial. The company has specifically advanced alidornase alfa to improve the enzyme’s efficacy in CF subjects.
The phase II study is a 28-day switch-over trial to assess the efficacy and safety of alidornase alfa in CF subjects previously cured with Pulmozyme®. Participation in the study is preceded by a 2-week failure period from Pulmozyme® before therapy with alidornase alfa through inhalation.
The initial efficacy report demonstrates that alidornase alfa enhances lung function as shown by a mean absolute jump in the ppFEV1 of 4.1 points measured from baseline. A commercially obtainable small molecule CFTR modulator for the management of CF has stated a mean absolute surge in ppFEV1 of 2.5 from reference point in its registration clinical trial. This score was recorded while 74% of the subjects participating in the study of the CFTR modulator were treated with Pulmozyme® in addition of the modulator.
While this CFTR addresses a specific mutation pertinent to less than 50% of CF subjects, alidornase alfa is being advanced to treat all CF subjects. Sputa accessible DNA samples were evaluated for almost 50% of the patients. A mean decline of almost 60% in DNA content from standard was observed, and a mean decline of approximately 90% from standard was seen for sputa visco-elasticity.