prothena corp plc (PRTA) Key Developments
Prothena Corporation plc Appoints Anders Härfstrand to its Board of Directors
Jun 29 15
Prothena Corporation plc announced the appointment of Anders Härfstrand, MD, PhD, to its Board of Directors. Anders' wealth of strategic expertise leading both entrepreneurial and large commercial organizations will serve as a valuable asset as continue development of pipeline of potential therapies, and in particular as move NEOD001 towards commercialization. Dr. Härfstrand was most recently the CEO of BBB Therapeutics BV.
Prothena Presents Clinical Results Demonstrating Robust, Rapid Reduction in Levels of Free Serum Alpha-Synuclein of Up to 96% After Single Dose of PRX002, Novel Protein Immunotherapy for Parkinson's Disease
Jun 17 15
Prothena Corporation plc presented clinical results from a Phase 1 single ascending dose study of PRX002, a monoclonal antibody for the potential treatment of Parkinson's disease and other related synucleinopathies. PRX002 is the focus of a worldwide collaboration between Prothena and Roche. Presented Presented now as part of the late breaking session at the 19thInternational Congress of Parkinson's Disease and Movement Disorders, the data demonstrated that PRX002 was safe and well-tolerated in healthy volunteers, meeting the primary objective of the study. Further, results from this study showed that administration of PRX002 led to a mean reduction of free serum alpha-synuclein levels of up to 96%. These overall results were highly statistically significant (p < 0.00001). Reduction of free serum alpha-synuclein, a protein potentially involved in the onset and progression of Parkinson's disease and the target of PRX002, was shown to be robust, rapid, and dose- and time-dependent after a single dose. The Phase 1 double-blind, placebo-controlled, single ascending dose study enrolled 40 healthy volunteers. All volunteers enrolled were randomized 3:1 into five escalating dose cohorts (0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg or 30 mg/kg) to receive either PRX002 or placebo. No serious adverse events or hypersensitivity reactions were reported. PRX002 demonstrated favorable pharmacokinetic properties, supporting the current dosing frequency in the on-going Phase 1 multiple ascending dose study in patients with Parkinson's disease. Treatment-emergent adverse events in greater than 5% of subjects were vessel puncture site pain, headache, viral infection, nausea, neutropenia, upper respiratory infection and pruritus. All PRX002-related adverse events were mild and no dose limiting toxicities were observed. No anti-drug antibodies were detected.
Prothena Corporation plc Announces First Human Dosed in Phase 1 Study of PRX003 for the Treatment of Psoriasis and Other Inflammatory Diseases
Jun 9 15
Prothena Corporation plc announced the successful first human dosing in a Phase 1 clinical trial of its proprietary protein immunotherapy, PRX003. PRX003 is a monoclonal antibody targeting melanoma cell adhesion molecule for the potential treatment of psoriasis and other inflammatory diseases. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to assess the safety, tolerability, pharmacokinetics and immunogenicity of PRX003. Prothena plans to enroll up to 40 subjects in the U.S. PRX003 is a monoclonal antibody for the potential treatment of psoriasis and other inflammatory diseases. Within the immune system, Th-17 white blood cells initiate the body's response to infections, and are known to be a key participant in both normal inflammatory reactions and autoimmune diseases. MCAM is expressed on the surface of Th-17 cells, and allows certain cells traveling in the blood stream to leave the circulation and enter tissues, primarily to initiate or continue a disease process. PRX003 is designed to block MCAM and not allow the migration of these pathogenic cells into tissues. PRX003 may be useful for treating a variety of inflammatory diseases such as psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis, sarcoidosis, uveitis, vasculitis, and Behcet's disease.
Prothena Corporation plc - Special Call
Jun 8 15
To discuss the clinical trial results from the Phase 1 single ascending dose study of PRX002
Prothena Corporation plc to Present Clinical Results from its Phase 1 Single Ascending Dose Study of PRX002
Jun 8 15
Prothena Corporation plc announced that Gene Kinney, PhD, Chief Scientific Officer and Head of Research and Development of Prothena, will highlight clinical results from a Phase 1 single ascending dose study of PRX002, as part of the late breaker abstract track, during a poster presentation at the 19th International Congress of Parkinson's Disease and Movement Disorders to be held June 14 to 18, 2015 in San Diego, CA. PRX002 is a monoclonal antibody for the potential treatment of Parkinson's disease and other related synucleinopathies, and the focus of a worldwide collaboration between Prothena and Roche.