Grifols Initiates Clinical Investigation of New Treatment Protocol for Alzheimer's DiseaseBy Grifols Sa, PRNE
Tuesday, June 1, 2010
BARCELONA, Spain, June 2, 2010 -
A new medical trial is expected to start in January 2011
— Interim results from an earlier trial published in September 2009
showed promise in the treatment of Alzheimer's Disease using therapeutic
plasmapheresis combined with infusions of human albumin.
— The new 2011 clinical investigation will complement the earlier trial
by using a combined treatment of therapeutic plasmapheresis and the
administration of human albumin and intravenous immune globulin (IVIG).
— Fenwal, Inc. has agreed to design and develop a proprietary prototype
of a plasmapheresis device specifically designed to support the new clinical
research on the treatment of Alzheimer's Disease.
Grifols, SA, a global healthcare company focused on clinical applications
of human plasma proteins, announced at its annual meeting with investors and
analysts, that it will initiate a new clinical investigation of Alzheimer's
Disease in January 2011 with an anticipated enrollment of over 300 patients.
The new clinical investigation involves a combined treatment of
therapeutic plasmapheresis and the administration of human albumin and
intravenous immune globulin (IVIG) at different doses and frequencies. Human
albumin and IVIG are two of the main therapeutic plasma proteins Grifols'
produces from donations of human blood plasma at dedicated donation centers
across the United States.
In conjunction with the announcement of the new clinical investigation,
Grifols also announced that it has entered into an exclusive design and
development agreement with U.S.-based Fenwal, Inc. (www.fenwalinc.com),
for the production of a prototype plasmapheresis device specifically
adapted for use in Grifols' Alzheimer's research. Fenwal is expected to
deliver the first prototype devices at the end of this year.
It is anticipated that the 2011 study will take place over the course of
"This is a promising new area of medicine with the potential to
significantly improve the quality of life for millions of people and
families," said William H. Cork, the Chief Technology Officer and Senior Vice
President for Fenwal. "We are pleased to partner with Grifols in exploring
this new approach to plasma-based therapy for treating Alzheimer's Disease.
We believe our apheresis technology is uniquely well-suited to a range of
therapeutic applications," Cork said.
In September 2009 Grifols published the interim results of a clinical
trial including 42 patients from three hospital research centers in Spain and
two in the United States. That study involved therapeutic plasmapheresis and
the administration of human albumin. The preliminary results suggested a
trend toward disease stabilization in the treatment group. The newly
announced clinical investigation builds off of the results of the prior study
by expanding the number of subjects and altering the treatment regimen.
Grifols' research into Alzheimer's Disease is consistent with its
research and development goals of accessing the full therapeutic benefits of
human blood plasma proteins for the benefit of individuals suffering with
About Alzheimer's Disease
It is believed that Alzheimer's disease will reach epidemic proportions
in the 21st century, with a relentless impact on the elderly population in
developed countries. According to the Alzheimer's Association, the illness
affects 10% of people over 65 and as many as 30% of those over 85. In the
United States there are 4.5 million sufferers, and it has been calculated
that this could rise to 15 million by 2050. The direct and indirect health
costs of caring for patients are estimated at 85 billion euros per year in
the United States alone.
Plasmapheresis is a technique used to separate plasma from other blood
components such as red blood cells, platelets and other cells. When somebody
donates plasma, these other components are returned to the donor during the
In the case of therapeutic plasmapheresis, the process is similar, but
most of the patient's plasma is extracted and replaced with albumin, which is
used to suspend the blood cells prior to reinfusion. The generalized use of
the technique of plasmapheresis as a method of obtaining plasma is the result
of research conducted by Dr. J. A. Grifols Lucas in the 1940s, which he
presented at the International Transfusion Congress held in Lisbon in 1951.
Fenwal, Inc. is a global medical technology company focused on improving
blood collection, filtration, separation, storage and transfusion to ensure
the availability, safety and effectiveness of blood and its components.
Fenwal is unique in the depth of its experience and commitment to transfusion
medicine. The company offers the broadest range of products for the automated
and manual collection of blood and blood components. Fenwal became an
independent company in 2007, but its roots go back to 1949 with the founding
of Fenwal Laboratories. Fenwal developed the first flexible, single-use
container for blood collection, eliminating complications associated with
glass containers and allowing blood to be separated into therapeutic
components. Today, the company's products and advanced collection and
separation technologies are used to help treat patients on six continents.
Fenwal, Inc. is based in Lake Zurich, Illinois. For more information, please
Grifols is a Spanish holding company specialized in the
pharmaceutical-hospital sector and is present in more than 90 countries.
Since 2006, the company has been listed on the Spanish Stock Exchange
("Mercado Continuo") and is part of the Ibex-35. Currently it is the first
company in the European sector in plasma derivatives and the fourth in
production worldwide. In upcoming years, the company will strengthen its
leadership in the industry as a vertically integrated company, thanks to
recent investments. In terms of raw materials, Grifols has ensured its plasma
supply with 80 plasmapheresis centers in the United States and in terms of
fractionation, its plants in Barcelona (Spain) and Los Angeles (United
States) will allow the company to respond to the growing market demand.
Nevertheless, the company is preparing for sustained growth in the following
8-10 years and has launched an ambitious investment plan. Visit
www.grifols.com for more information.
Chris Healey, Grifols, SA, +1-703-351-5004
Tags: Barcelona, Europe, Grifols Sa, June 2, Spain