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2016-11-03

Prothena Corporation plc: Data for Prothena's NEOD001 to be Presented at the 58th Annual American Society of Hematology Meeting

Data for Prothena's NEOD001 to be Presented at the 58th Annual American Society of Hematology Meeting
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

* Presenter: Morie A. Gertz, MD, Professor of Medicine, Mayo Clinic
* Session: 653. Myeloma: Therapy, Excluding Transplantation: Amyloidosis
* Date and Time: Monday, December 5, 7:15 AM PT
* Location: San Diego Convention Center, Hall AB

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

* Presenter: Michaela Liedtke, MD, Stanford Comprehensive Cancer Center
* Session: 653. Myeloma: Therapy, Excluding Transplantation: Amyloidosis
* Date and Time: Monday, December 5, 8:00 AM PT
* Location: San Diego Convention Center, Hall AB

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

* Presenter: Spencer Guthrie, Head of Development Affairs, Prothena
Biosciences Inc
* Session: 904 - Outcomes Research - Malignant Conditions: Poster II
* Date and Time: Sunday, December 4, 6:00 - 8:00 PM, PT
* Location: San Diego Convention Center, Hall GH

(Abstract #3586) Changes in Health-related Quality of Life Corresponding to
Hematologic Response to Treatment in AL Amyloidosis

* Presenter: Vaishali Sanchorawala, M.D., Assoc. Director, Amyloidosis
Center, Boston University Medical Center
* Session: 903 - Outcomes Research - Non-malignant Conditions: Poster II
* Date and Time: Sunday, December 4, 6:00 - 8:00 PM, PT
* Location: San Diego Convention Center, Hall GH

(Abstract #4753) Treatment-related Symptoms and Impact on Health Related
Quality of Life in AL Amyloidosis

* Presenter: Michelle K. White, PhD, Sr. Scientist and Sr. Director, Optum
* Session: 903 - Outcomes Research - Non-malignant Conditions: Poster II
* Date and Time: Sunday, December 4, 6:00 - 8:00 PM, PT
* Location: San Diego Convention Center, Hall GH

About NEOD001

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.

About Prothena

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.
Contacts:
Investors: Tran Nguyen, CFO
650-837-8535, IR@prothena.com

Media: Ellen Rose, Head of Communications
650-922-2405, ellen.rose@prothena.com

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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

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