Protalix Biotherapeutics Inc (NYSEMKT:PLX) has released some positive interim results from its ongoing phase-2 clinical trials of alidornase alfa. The study comprises a total of 15 patients, suffering from Cystic Fibrosis (CF). However, the interim data is for the first 13 patients only. The company noted that alidornase is a plant cell, chemically modified recombinant DNase enzyme, which resists actin. The enzyme has been clinically modified by PLX, so as to be more efficient in CF patients.
The phase-2 clinical trial is a switch-over study, spread over a 28-day period, to evaluate the safety and efficacy of the drug. Moreover, the trial population has already been treated with Pulmozyme and has undergone a 2-week washout period, prior to start of the study. It should be noted here that the drug is being administered to the patients via inhalation. In the interim results, PLX noted that there was an overall improvement in lung function, amongst the patients. Moreover, only mild and transient adverse events were observed during the trials.
Moshe Manor, the CEO of Protalix, expressed his enthusiasm at the results and claimed that they had observed efficacy in a way that had not been seen in the CF space for a long period. He further stated that the complete results would be released prior to the end of the 1Q2017. The head of the Cystic Fibrosis Center at Hadassah University Hospital, Professor Eiten Kerem, stated that they had compared their results to previously conducted studies on CF treatments and they found their research to be very encouraging. He further claimed that the study provided some clinically meaningful results, despite the fact that it was conducted on a small number of patients.
PLX earlier announced that its letter of intent to sell alfataliglicerase, for the treatment of Gaucher patients in Brazil, through the Brazilian Ministry of Health, has been confirmed. As such, the company would start shipping the products to the country, from mid-2017. Added to this, Protalix is expected to generate $24.3 million in shipments during the year.
Protalix Biotherapeutics Inc (NYSEMKT:PLX) lost 7.84% of its share value, during the January 3 trading session, to close at $0.41 per share.