Neuroimaging shows AMBAR clinical trial's positive effects
in patients with mild-to-moderate Alzheimer's disease
BARCELONA, Spain, Dec. 6, 2019 /PRNewswire/ -- Grifols (MCE: GRF,
MCE: GRF.P, NASDAQ: GRFS), a leading global producer of
plasma-derived medicines, today concluded more than a year of
encouraging results of its AMBAR (Alzheimer Management by Albumin
Replacement) clinical trial with the presentation of new
neuroimaging data that show the reduction in the progression of the
disease in patients with mild-to-moderate Alzheimer's disease.
These findings, released at the Clinical Trials on Alzheimer's
Disease (CTAD) Conference 2019 in San
Diego, Calif. (USA), strengthen Grifols' investigative
approach using Plasma Protein Replacement Therapies.
The neuroimaging, which was measured by the FDG-PET1
technique, shows positive results particularly in patients
receiving both albumin and immunoglobulin (IG). In comparison with
the placebo group, these patients had less reduction of brain
glucose metabolism over the 14 months of the clinical trial. This
suggests that neuronal damage was reduced in these patients (see
figure).
The images display the extension and distribution of the dark
spots that relate to the reduction of glucose metabolism in the
brain. Fewer and lighter spots suggest less neuronal damage, which
is observed in the patients receiving both albumin and IG compared
with placebo.
Grifols presented the first AMBAR results at the 11th
CTAD Conference in Barcelona in
October 2018. The primary efficacy
endpoints, the ADAS-Cog2 and ADCS-ADL3
scales, showed a 61% reduction in disease progression for both
measures in the cohort of patients with moderate Alzheimer's.
Additional data covering the secondary endpoints of the study,
such as memory and language, were presented at the 14th
International Conference on Alzheimer's and Parkinson's Diseases
(AD/PD) in Lisbon (Portugal) in March
2019, and showed a positive impact in both mild and moderate
patients.
Results of other relevant endpoints, CDR-Sb4 and
ADCS-CGIC5, evaluating both functional and cognitive
capacity, were presented at the Alzheimer's Association
International Conference (AAIC) 2019 in Los Angeles, Calif. (USA) in July, and also
pointed in the same direction when considering all treated patients
together.
The CDR-Sb scale – which assesses memory, orientation, judgment,
community affairs, home and hobbies, and personal care – showed a
71% reduction in clinical decline with respect to placebo in
patients treated as a whole and in all three clinical trial
treatment arms analyzed separately.
For the ADCS-CGIC scale – which assesses several domains of
cognition, daily functioning and behavior from both the patient and
the caregiver perspective – a stabilization was observed in
all treated patients with respect to placebo. This effect remained
in all three clinical trial treatment arms when analyzed
separately.
"The AMBAR trial's results are encouraging news for
mild-to-moderate Alzheimer's patients. These findings are the
consequence of 15 years of rigorous scientific research at
Grifols and the company will continue investigating this
devastating condition that affects millions of patients around the
world," said Dr. Antonio Páez, Medical Director of the AMBAR
Clinical Program at Grifols.
Grifols will soon meet with the FDA to discuss the AMBAR
clinical development program and the design of a successive AMBAR
II trial that will deepen and complement the just-concluded
one.
About AMBAR
AMBAR is an international, multicenter, randomized,
double-blind, placebo-controlled, with parallel assignment clinical
trial that enrolled patients with mild and moderate Alzheimer's
from 41 treatment centers in Spain
and the United States. The study
was designed to evaluate the efficacy and safety of short-term
plasma exchange followed by long-term plasmapheresis with infusion
of albumin combined with intravenous immunoglobulin in patients
with mild and moderate Alzheimer's disease.
AMBAR was designed to evaluate whether the progression of
Alzheimer's could be stabilized through therapeutic plasma
exchange, a process that entails periodically extracting plasma and
infusing albumin solution (Albutein®) with or without intravenous
immunoglobulin (Flebogamma® DIF).
AMBAR targets a multimodal approach to the management of the
disease based on the hypothesis that most of the amyloid-beta
protein – one of the proteins accumulated in the brains of
Alzheimer's patients – is bound to albumin and circulates in
plasma. Extracting this plasma may flush amyloid-beta peptide from
the brain into the plasma, thus limiting the disease's impact on
the patient's cognitive functions. Additionally, albumin has
binding capacity and antioxidant properties, and both albumin and
immunoglobulin display immunomodulatory and anti-inflammatory
properties.
The AMBAR study included 496 mild and moderate Alzheimer's
patients, 55-85 years-old, randomized in three treatment groups and
one control (placebo) group. An independent contract research
organization (CRO) oversaw the trial's clinical monitoring phase
and managed the data collection and analysis stages. The trial
employed a randomized and double-blind design, meaning that neither
patients nor evaluators knew whether subjects were receiving the
treatment or the placebo.
The company began its research on Alzheimer's disease in 2004
with several preclinical trials, two pilot studies and a Phase II
clinical trial before launching the AMBAR trial.
Fundació ACE in Barcelona,
Spain, and the Alzheimer Research Center of the University of Pittsburgh, PA, USA, have been
instrumental partners in the AMBAR research and in Grifols
Alzheimer's program since its initiation in 2004.
For more information on the AMBAR study and the results
presented visit: ambar.grifols.com
About Grifols
Grifols is a global healthcare company that since 1909 has
enhanced the health and well-being of people around the world. Its
four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies
– develop, produce and market innovative solutions and services in
more than 100 countries.
As pioneers in the plasma industry, Grifols is one of the
largest plasma companies, with a growing network of donation
centers worldwide. It develops this plasma into essential medicines
used to treat rare, chronic and, at times, life-threatening
conditions. As a recognized leader in transfusion medicine, Grifols
also offers a comprehensive portfolio of solutions designed to
enhance safety from donation through transfusion. And the company
supplies tools, information and services that enable hospitals,
pharmacies and healthcare professionals to efficiently deliver
expert medical care.
Grifols, with more than 24,000 employees in 30 countries, is
committed to a sustainable business model that sets the standard
for continuous innovation, quality, safety and ethical leadership
in the industry.
The company's class A shares are listed on the Spanish Stock
Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols
non-voting class B shares are listed on the Mercado Continuo
(MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).
For more information, please visit grifols.com.
LEGAL DISCLAIMER
The facts and figures contained
in this report that do not refer to historical data are "future
projections and assumptions". Words and expressions such as
"believe", "hope", "anticipate", "predict", "expect", "intend",
"should", "will seek to achieve", "it is estimated", "future" and
similar expressions, in so far as they relate to the Grifols group,
are used to identify future projections and assumptions. These
expressions reflect the assumptions, hypotheses, expectations and
predictions of the management team at the time of writing this
report, and these are subject to a number of factors that mean that
the actual results may be materially different. The future results
of the Grifols group could be affected by events relating to its
own activities, such as a shortage of supplies of raw materials for
the manufacture of its products, the appearance of competitor
products on the market, or changes to the regulatory framework of
the markets in which it operates, among others. At the date of
compiling this report, the Grifols group has adopted the necessary
measures to mitigate the potential impact of these events. Grifols,
S.A. does not accept any obligation to publicly report, revise or
update future projections or assumptions to adapt them to events or
circumstances subsequent to the date of writing this report, except
where expressly required by the applicable legislation. This
document does not constitute an offer or invitation to buy or
subscribe shares in accordance with the provisions of the following
Spanish legislation: Royal Legislative Decree 4/2015, of 23
October, approving recast text of Securities Market Law;
Royal Decree Law 5/2005, of 11 March
and/or Royal Decree 1310/2005, of 4
November, and any regulations developing this legislation. In
addition, this document does not constitute an offer of purchase,
sale or exchange, or a request for an offer of purchase, sale or
exchange of securities, or a request for any vote or approval in
any other jurisdiction. The information included in this document
has not been verified nor reviewed by the external auditors of the
Grifols group.
1 FDG-PET: Fluorodeoxyglucose Positron Emission
Tomography.
2 ADAS-Cog: Alzheimer's Disease Assessment Scale –
Cognitive.
3 ADCS-ADL: Alzheimer's Disease Cooperative Study –
Activities of Daily Living.
4 CDR-Sb: Clinical Dementia Rating Scale – Sum of
Boxes.
5 ADCS-CGIC: Alzheimer's Disease Cooperative Study –
Clinical Global Impression of Change.
Photo
- https://mma.prnewswire.com/media/1041341/Grifols___Brain_Images.jpg
Logo
- https://mma.prnewswire.com/media/463444/Grifols_Logo.jpg