LONDON, UK / ACCESSWIRE / December 29, 2017 / Active-Investors.com has just released a free research report on Protalix BioTherapeutics, Inc. (NYSE: PLX). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=PLX as the Company’s latest news hit the wire. On December 27, 2017, the Company announced that the European Commission (EC) granted Orphan Drug Designation (ODD) for pegunigalsidase alfa, or PRX-102, for the treatment of Fabry disease. Register today and get access to over 1000 Free Research Reports by joining our site below: www.active-investors.com/registration-sg.
Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Protalix BioTherapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below: www.active-investors.com/registration-sg/?symbol=PLX.
PRX-102 is a recombinant, plant cell expressed, pegylated, modified version of the human alpha-Galactosidase-A enzyme which has been developed for the treatment of Fabry disease.
Why the Orphan Drug Designation is Important?
The approval by the Commission to grant the ODD confirmed the earlier opinion issued by the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), announced on November 13, 2017. To be eligible for orphan medicinal product designation, Protalix was required to establish medically plausible evidence that PRX-102 will provide a significant benefit over existing approved therapies in the European Union (EU) for the treatment of Fabry disease.
In its official opinion letter, the COMP explained that Protalix has established that although satisfactory methods of treatment of Fabry disease have been authorized in the European Union, PRX-102 will be of significant benefit to those affected by Fabry disease. The COMP cited clinical and non-clinical justifications provided by Protalix to establish the significant benefit of pegunigalsidase alfa, noting that the COMP considered them to constitute a clinically relevant advantage. The ODD for pegunigalsidase alfa qualifies the sponsor for access to the centralized marketing authorization procedure, including applications for inspections and for protocol assistance.
If the ODD is maintained at the time PRX-102 is approved for marketing in the EU, the Company expects that PRX-102 will benefit from ten years of market exclusivity within the EU.
Positive Results from the Study
On November 27, 2017, Protalix announced positive results from its Phase-I/II open label extension trial of pegunigalsidase alfa, or PRX-102.
As part of the study, sixteen male and female adult patients were enrolled in the phase-I/II clinical trial across three dosing cohorts (0.2 mg/kg, 1mg/kg and 2mg/kg) and received intravenous infusions of PRX-102 every two weeks.
Efficacy Data for the trial recorded at 24 months
Lyso Gb3 levels decreased approximately 90% from baseline;
Renal function remained stable with mean eGRF levels of 108.02 and 107.20 at baseline and 24 months, respectively;
Improvement across all the gastrointestinal symptoms evaluated, including severity and frequency of abdominal pain and frequency of diarrhea;
Cardiac parameters, including LVM, LVMI and EF, remained stable with no cardiac fibrosis development detected;
In conclusion, an improvement of over 40% in disease severity was shown as measured by the Mainz Severity Score Index (MSSI), a score compiling the different elements of the disease severity including neurological, renal and cardiovascular parameters.
The long-term results at 24 months indicated that PRX-102 demonstrated a remarkable improvement and stability across all key Fabry disease parameters. PRX-102 was also well tolerated, with a very low incidence of treatment induced anti-drug antibodies that were reversible with only a transient and reversible effect on pharmacokinetics, these long-term results further support that PRX-102 has the potential to be a significant differentiated therapy when compared to currently approved enzyme replacement therapies.
Stock Performance Snapshot
December 28, 2017 – At Thursday’s closing bell, Protalix BioTherapeutics’ stock advanced 1.55%, ending the trading session at $0.67.
Volume traded for the day: 1.21 million shares.
Stock performance in the previous three-month period – up 12.81%; past twelve-month period – up 74.10%; and year-to-date – up 50.58%
After yesterday’s close, Protalix BioTherapeutics’ market cap was at $93.63 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.2% at the end of the session.
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