Results for Prothena's Phase 1b Multiple Ascending Dose Study of PRX002...
(Thomson Reuters ONE) -
Results for Prothena's Phase 1b Multiple Ascending Dose Study of PRX002/RG7935
in Patients with Parkinson's Disease to be Presented at the 13th International
Conference on Alzheimer's and Parkinson's Diseases
* Investor webcast planned for April 2, 2017 at 9:00 AM EDT to discuss Phase
1b study results
* Prothena and Roche to co-host symposium on alpha-synuclein pathology and
non-motor manifestations in Parkinson's disease on March 31, 2017 at 5:15
CET
DUBLIN, Ireland, March 09, 2017 (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 the Phase 1b multiple ascending dose
study of PRX002 in patients with Parkinson's disease will be highlighted in an
oral presentation in the late-breaking therapeutic strategies session at the
13th International Conference on Alzheimer's and Parkinson's Diseases (AD/PD),
to be held March 29 - April 2, in Vienna, Austria. PRX002, also known as RG7935,
is a monoclonal antibody for the potential treatment of Parkinson's disease and
other related synucleinopathies, and is the focus of a worldwide collaboration
between Prothena and Roche. A Phase 2 clinical study of PRX002/RG7935 in
patients with Parkinson's disease is expected to begin in 2017.
Clinical data from the Phase 1b multiple ascending dose study of PRX002/RG7935
in patients with Parkinson's disease, will be presented in the following oral
session:
Results from a Phase 1b Multiple Ascending-dose Study of PRX002/RG7925, An Anti-
alpha-synuclein Monoclonal Antibody, in Patients with Parkinson's Disease
* Presenter: Joseph Jankovic, MD, Distinguished Chair in Movement Disorders,
Baylor College of Medicine
* Session: Symposium 58 - Late Breaking Therapeutic Strategies in AD and PD
* Date and Time: Oral presentation - Sunday, April, 2, 12:00 - 12:15 PM CET
(6:00 - 6:15 AM EDT)
* Location: Hall C, Austria Center, Vienna, Austria
An investor conference call and webcast to discuss the results is planned for
Sunday, April 2, 2017 at 9:00 AM EDT, and dial-in details will be made
available in advance of the call.
In addition, an abstract on the feasibility of using smartphone-based
assessments and sensors to monitor symptoms and mobility in patients with early-
stage Parkinson's disease will be presented in the following oral presentation:
Remote, High-frequency Monitoring of Motor Symptoms in Early-stage Parkinson's
Disease Patients in the Phase 1b RG7935/PRX002 Clinical Trial
* Presenter: Michael Lindemann, Professor, Baden-Württemberg Cooperative State
University
* Session: Symposium 58 - Late Breaking Therapeutic Strategies in AD and PD
* Date and Time: Oral presentation - Sunday, April, 2, 12:15 - 12:30 PM CET
(6:15 - 6:30 AM EDT)
* Location: Hall C, Austria Center, Vienna, Austria
Prothena and Roche to Co-Host Symposium
In addition to the scientific presentation, leading researchers in the field of
Parkinson's disease will present at a symposium entitled "Beyond the Basal
Ganglia: Alpha-synuclein Pathology and Non-motor Manifestations in Parkinson's
Disease" during the conference. The symposium will be held on March 31, 2017 at
5:15 PM local time, and will feature experts from around the world, including:
Thomas Beach, MD, PhD, Sun Health Research Institute, Sun City; Patrik Brundin,
MD, PhD, Van Andel Research Institute, Grand Rapids; Jamie L Eberling, PhD, The
Michael J. Fox Foundation for Parkinson's Research, New York; Tom Isaacs, The
Cure Parkinson's Trust, Rickmansworth, Herts; Brit Mollenhauer, MD, Georg-August
University Göttingen, Göttingen; Wolfgang Oertel, MD, PhD, of University of
Marburg, Marburg; Ronald Postuma, MD, MSc, McGill University, Montreal.
About Alpha-synuclein
Alpha-synuclein, a protein found in neurons and other cells, is a major
component of pathology that characterizes several neurodegenerative disorders
including Parkinson's disease, dementia with Lewy bodies, and multiple system
atrophy, which collectively are termed synucleinopathies. While the normal
function of alpha-synuclein is not well understood, the protein generally occurs
in a soluble form. In synucleinopathies, the alpha-synuclein protein can misfold
and aggregate to form soluble aggregates and insoluble fibrils that contribute
to disease pathology. There is increasing evidence that this disease-causing
alpha-synuclein can be propagated and transmitted from neuron to neuron,
resulting in an infection-like spread of neuronal death. Recent studies in
cellular and animal models suggest that the spread of alpha-synuclein-associated
neurodegeneration can be disrupted by targeting aberrant forms of alpha-
synuclein.
About PRX002/RG7935
PRX002/RG7935 is a monoclonal antibody under development for the potential
treatment of Parkinson's disease. PRX002/RG7935 targets alpha-synuclein and is
designed to slow the progressive neurodegeneration associated with alpha-
synuclein misfolding and/or the cell-to-cell transmission of the aggregated
pathogenic forms of alpha-synuclein found in Parkinson's disease and other
synucleinopathies. Prior to initiating clinical trials, Prothena demonstrated
the efficacy of PRX002/RG7935 in various cellular and animal models of alpha-
synuclein-related disease. In multiple transgenic mouse models of Parkinson's
disease, the murine version of PRX002/RG7935, reduced the appearance of alpha-
synuclein pathology, protected synapses and improved performance in behavioral
testing. In December 2013 Prothena and Roche entered into a worldwide
collaboration to develop and commercialize antibodies that target alpha-
synuclein, including PRX002/RG7935. Prothena has an option to co-promote
PRX002/RG7935 in the U.S., where the companies share all development and
commercialization costs, as well as profits, on a 30/70 basis (30 percent
Prothena, 70 percent Roche). Outside the U.S., Roche will have sole
responsibility for developing and commercializing PRX002/RG7935 and will pay
Prothena up to double-digit royalties on net sales. A Phase 2 clinical study of
PRX002/RG7935 in patients with Parkinson's disease is expected to begin in 2017.
About Parkinson's Disease
Parkinson's disease is a progressive degenerative disorder of the central
nervous system (CNS) that affects one in 100 people over age 60. With an
estimated seven to 10 million patients living with Parkinson's disease
worldwide, it is the second most common neurodegenerative disorder after
Alzheimer's disease. The disease is characterized by the neuronal accumulation
of aggregated alpha-synuclein in the CNS and peripheral nervous system that
results in a wide spectrum of worsening progressive motor and non-motor
symptoms. While diagnosis relies on motor symptoms classically associated with
Parkinson's disease, non-motor symptoms may present many years earlier. Current
treatments for Parkinson's disease are symptomatic and only address a subset of
symptoms such as motor impairment, dementia, or psychosis. Symptomatic therapies
do not target the underlying cause of the disease and lose effectiveness, often
leading to debilitating side effects as the disease progresses.
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, plans for and the timing of initiating a Phase 2
clinical study of PRX002/RG7935; and the design of PRX002/RG7935 and its
potential as a disease modifying treatment for Parkinson's disease. 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 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.
Contacts:
Investors: Tran Nguyen, CFO
650-837-8535, IR(at)prothena.com
Media: Ellen Rose, Head of Communications
650-922-2405, ellen.rose(at)prothena.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Prothena Corporation plc via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 09.03.2017 - 22:05 Uhr
Sprache: Deutsch
News-ID 529405
Anzahl Zeichen: 11260
contact information:
Town:
DUBLIN
Kategorie:
Business News
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