Grifols Initiates Clinical Investigation Of New Treatment Protocol For Alzheimer's DiseaseGrifols, 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., 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 DiseaseIt 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.
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