Prothena to Present New Research on Cardiac Biomarker NT-proBNP in AL Amyloidosis at HFSA Annual Meeting
August 15 2017 - 4:05PM
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 new clinical and preclinical research on the cardiac biomarker
NT-proBNP will be presented in both oral and poster sessions at the
Heart Failure Society of America (HFSA) Annual Scientific Meeting
to be held September 16 – 19 in Dallas, Texas. NT-proBNP is a
cardiac biomarker that has been consistently shown, in multiple
independent studies, to be predictive of survival in patients with
AL amyloidosis (Merlini, et. al, Leukemia, 2016).
New preclinical data demonstrating that
misfolded light chains promote oxidative stress and cellular
toxicity and increase NT-proBNP production in cardiomyocytes will
be highlighted in oral and poster sessions. The findings provide
mechanistic insight into how misfolded light chain protein induces
cardiotoxicity and support the relationship between lowering of
NT-proBNP and improved survival in patients with AL
amyloidosis.
(Abstract
#017) Aggregated Light Chain Increases Brain
Natriuretic Peptide Expression and Induces Oxidative Stress
Response in Cardiomyocytes
- Presenter: Stephen J. Tam, Senior Scientist,
Prothena
- Session: Rapid Fire Abstract Session I
- Date and Time: Sunday, September 17, 1:00 PM, CT
- Location: Gaylord Texan Hotel and Convention Center,
Grapevine 1-3
- The abstract will also be presented as a poster in the Exhibit
Hall, Saturday, September 16 – Monday, September 18
In addition, new outcomes research that
demonstrates NT-proBNP response is associated with clinically
meaningful improvements in health-related quality of life in
patients with AL amyloidosis will also be presented in a poster
session. The research supports that NT-proBNP may be useful as a
surrogate for clinical measures such as health-related quality of
life.
(Abstract
#319) Improvements in Cardiac
Biomarkers are Associated with Better Health Related Quality of
Life in Patients with Light Chain Amyloidosis
- Presenter: Tiffany Quock, Director, Health Economics and
Outcomes Research, Prothena
- Session: Quality of Care / Outcomes
- Date and Time: Saturday, September 16, 6:15 - 7:15 PM,
CT
- Location: Gaylord Texan Hotel and Convention Center,
Exhibit Hall
About NEOD001
NEOD001 is an investigational first-in-class
antibody that specifically targets disease-causing misfolded light
chain aggregates in AL amyloidosis. There are two ongoing global
clinical studies for NEOD001. The PRONTO study, a global, Phase 2b,
double-blind, placebo-controlled, registration-directed study, will
evaluate NEOD001 vs. placebo in previously-treated patients with AL
amyloidosis and persistent cardiac dysfunction, and will assess
best response over 12 months of the cardiac 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 vs.
placebo in newly-diagnosed, treatment-naïve patients with AL
amyloidosis and cardiac dysfunction, with both arms of the study
receiving standard of care. The VITAL study 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
diseases caused by tissue deposition of misfolded proteins that
result in progressive organ damage. AL amyloidosis, the most common
type, is a rare, progressive, and typically fatal disease caused by
extracellular deposition of misfolded immunoglobulin light chains.
An excess of light chains prone to misfolding are produced by
clonal plasma cells. Soluble toxic aggregates and deposited
fibrils (amyloid) lead to progressive failure of vital organs
including the heart, kidneys and nervous system, causing
significant morbidity and mortality. It is estimated that
approximately 30,000 – 45,000 patients in the U.S. and Europe
suffer from this disease. There are no approved treatments for AL
amyloidosis, although patients may be treated with off-label
therapies directed at the plasma cell dyscrasia. There is a large
unmet need for therapies that specifically target soluble toxic
aggregates and deposited fibrils, thereby improving vital organ
function. For more information on AL amyloidosis, please visit the
websites of the Amyloidosis Support Groups, The Amyloidosis
Research Consortium, and the Amyloidosis Foundation.
About Prothena
Prothena Corporation plc is a global, late-stage
clinical biotechnology company establishing fully-integrated
research, development and commercial capabilities. 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 seeks to fundamentally change the course of progressive
diseases associated with this biology. The Company’s pipeline of
antibody therapeutic candidates targets a number of indications
including AL amyloidosis (NEOD001), Parkinson’s disease and other
related synucleinopathies (PRX002/RG7935), inflammatory diseases,
including psoriasis and psoriatic arthritis (PRX003), and ATTR
amyloidosis (PRX004). The Company continues discovery of additional
novel therapeutic candidates where its deep scientific
understanding of disease pathology can be leveraged. For more
information, please visit the Company’s website
at www.prothena.com.
Forward-looking Statements
This press release contains forward-looking
statements. These statements relate to, among other things, the
relationship between amyloid light chain toxicity and NT-proBNP
production; the correlation between NT-proBNP and health-related
quality of life; the relationship between lowering of NT-proBNP and
improved survival in patients with AL amyloidosis; and whether
NT-proBNP may be useful as a surrogate for clinical measures such
as health-related quality of life. These statements are based on
estimates, projections and assumptions that may prove not to be
accurate, and actual results could differ materially from those
anticipated due to known and unknown risks, uncertainties and other
factors, including but not limited to the risks, uncertainties and
other factors described in the “Risk Factors” sections of our
Annual Report on Form 10-K filed with the Securities and Exchange
Commission (SEC) on February 27, 2017 and our subsequent Quarterly
Reports on Form 10-Q filed with the SEC. Prothena undertakes no
obligation to update publicly any forward-looking statements
contained in this press release as a result of new information,
future events or changes in Prothena's expectations.
Media & Investor Contact:
Ellen Rose, Head of Communications
650-922-2405, ellen.rose@prothena.com
Prothena (NASDAQ:PRTA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Prothena (NASDAQ:PRTA)
Historical Stock Chart
From Apr 2023 to Apr 2024