BARCELONA, Spain, June 2, 2010 /PRNewswire/ --
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. (http://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 two years.
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 debilitating disease.
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 donation process.
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 visit http://www.fenwalinc.com.
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 http://www.grifols.com for more information.
SOURCE: Grifols, SA
CONTACT: Chris Healey, Grifols, SA, +1-703-351-5004