DUBLIN, Ireland, Nov. 03, 2016 (GLOBE NEWSWIRE) -- Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, today announced that clinical data from its NEOD001 Phase 1/2 dose-escalation and expansion study will be highlighted in two oral presentations, and data highlighting quality of life measures in patients with AL amyloidosis will be featured in three posters at the 58th Annual American Society of Hematology (ASH) Meeting to be held December 3-6, 2016, in San Diego, CA.
Clinical results of the Phase 1/2 dose-escalation and expansion study as of a May 9, 2016 data analysis were presented at the International Symposium on Amyloidosis (ISA) in Uppsala, Sweden on July 5, 2016. The two upcoming oral presentations at ASH will highlight additional aspects of the study results, as outlined below.
(Abstract #644) NEOD001 Demonstrates Organ Biomarker Responses in Patients with Light Chain Amyloidosis and Persistent Organ Dysfunction: Results from the Expansion Cohort of a Phase 1/2 Study
This presentation will contain updated patient case study data.
(Abstract #647) Organ Biomarker Responses in Patients with Light Chain Amyloidosis Treated with NEOD001 Are Independent of Previous Hematologic Response
This presentation will contain data demonstrating that patients treated with monthly NEOD001 infusions had favorable organ response rates that were independent of time since prior plasma cell dyscrasia (PCD) treatment, depth of hematologic response, or predominant type of PCD treatment.
In addition, three posters that highlight quality of life measures in patients with AL amyloidosis will also be presented:
(Abstract #3596) Burden of AL Amyloidosis on Health-related Quality of Life in Clinic-based, Community-based, and Trial-based Studies
(Abstract #3586) Changes in Health-related Quality of Life Corresponding to Hematologic Response to Treatment in AL Amyloidosis
(Abstract #4753) Treatment-related Symptoms and Impact on Health Related Quality of Life in AL Amyloidosis
NEOD001 is a monoclonal antibody that specifically targets the circulating soluble amyloid and deposited insoluble amyloid that accumulates in both the AL and AA forms of amyloidosis. Patients with AL amyloidosis may be eligible to enroll in one of two clinical studies for NEOD001. The PRONTO study, a global, Phase 2b, double-blind, placebo-controlled, registration-directed study, will evaluate NEOD001 in previously-treated patients with AL amyloidosis and persistent cardiac dysfunction, and will assess best response over 12 months of the cardiac functional biomarker NT-proBNP, defined by the consensus criteria of NT-proBNP change, in addition to other biomarker, quality of life and functional endpoints. The VITAL Amyloidosis Study, a global, Phase 3, double-blind, placebo-controlled, registrational study, is evaluating NEOD001 in newly-diagnosed, treatment-naïve patients with AL amyloidosis, and will assess a composite endpoint of all-cause mortality or cardiac hospitalizations in addition to biomarker, quality of life and functional endpoints. More information on the PRONTO study and The VITAL Amyloidosis Study is available at www.clinicaltrials.gov, by searching NCT #02632786 for PRONTO, and NCT #02312206 for VITAL or www.clinicaltrialsregister.eu, by searching EudraCT #2015-004318-14 for PRONTO, and EudraCT #2014-003865-11 for VITAL.
About AL Amyloidosis
Systemic amyloidoses are a complex group of progressive diseases caused by tissue deposition of misfolded proteins that result in progressive organ damage. The most common type, AL amyloidosis or primary amyloidosis, involves a hematological disorder caused by plasma cells that produce misfolded AL protein resulting in deposits of abnormal AL protein (amyloid) in the tissues and organs of individuals with this disease. There are no approved treatments for AL amyloidosis that directly target potentially toxic forms of the AL protein. AL amyloidosis is a rare disorder and it is estimated that about 30,000 to 45,000 patients in the U.S. and Europe suffer from this disease. Both the causes and origins of AL amyloidosis remain poorly understood. For more information on AL amyloidosis, please visit the websites of the Amyloidosis Support Group and the Amyloidosis Foundation.
Prothena Corporation plc is a global, late-stage clinical biotechnology company seeking to fundamentally change the course of progressive diseases with its clinical pipeline of novel therapeutic antibodies. Fueled by its deep scientific understanding built over decades of research in protein misfolding and cell adhesion — the root causes of many serious or currently untreatable amyloid and inflammatory diseases — Prothena is establishing a fully integrated research, development and commercial focus and has advanced several drug candidates into clinical studies while pursuing discovery of additional novel therapies. Our pipeline of antibody-based product candidates targets a number of potential indications including AL amyloidosis (NEOD001), Parkinson's disease and other related synucleinopathies (PRX002), inflammatory diseases, including psoriasis and psoriatic arthritis (PRX003), and ATTR amyloidosis (PRX004). For more information, please visit the company's website at www.prothena.com.GlobeNewswire
Last updated on: 03/11/2016
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