Clinical Advancements in Immunoglobulin Therapy
Immunoglobulin Therapy in Alzheimer's Disease:
Key Details and Summary Perspectives
"Reference for Clinical Advancement Vol 2" from http://www.americanoutcomes.com/files/FINAL-RESULTS-OF-THE-CORNELL-PHASE-II-MILD-to-MODERATE-ALZHEIMER.pdf.
Although IVIg is not currently approved to treat Alzheimer's disease, 35 academic institutions in conjunction with the NIH and the Alzheimer's Disease Cooperative Study Group have engaged in a Phase III clinical trial to try and confirm the encouraging results using IVIg that have been reported in the Phase I and Phase II trials. In the earlier trials it was shown that patients tolerated the IVIg therapy with minimal adverse reactions and all patients had stabilization of their cognitive abilities with many of them demonstrating a significant improvement in cognitive ability over the course of the six months of IVIg treatment.
Baxter announced April 13, 2010 at the American Academy of Neurology meeting the 18 month Phase II clinical trial results of Gammagard (IGIV) for mild-to-moderate Alzheimer's disease. The trial results indicated for the first time, positive data in all three areas of disease measurement including cognition, functional, and neuroimaging that were statistically significant. We see this as positive news in that Baxter is the market leader in IGIV therapies, which is derived from donated plasma, and Haemonetics is the market leader in plasma collection equipment/consumables. We believe that expanding use of IGIV to Alzheimer's patients would dramatically increase (possibly double) the demand for plasma as there are approximately 5 million patients suffering from Alzheimer's disease in the US alone. Baxter has initiated a Phase III trial, which is currently actively enrolling patients.
Key Details and Summary Perspectives
The Baxter sponsored 18 month study of Gammagard for mild-to-moderate Alzheimer's disease included approximately 24 Alzheimer's patients with 16 receiving Gammagard (IGIV) continuously for 18 months and 6 receiving a placebo. At the end of the study period, patients in the Gammagard arm showed a statistically significant improvement in function and cognition using the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change rating and the Alzheimer's Disease Assessment Scale.
In addition, the study presented for the first time, MRI analysis that showed Alzheimer's patients who received Gammagard had lower rates of brain ventricular enlargement, a sensitive measure of cognitive impairment, and lower rates of brain atrophy as compared to the placebo. The author of the study noted this is the first trial to show long-term clinical benefits of an investigation treatment for Alzheimer's disease, which resulted in reduced brain degeneration. Baxter has begun the larger Phase III trial studying Gammagard and Alzheimer's disease, which includes 35 sites and continues to enroll patients with initial results expected in 2011.
The Phase III trial on Alzheimer's disease is sponsored jointly by the National Institutes of Health (NIH) and Baxter Healthcare and includes 35 participating institutions. The 35 leading academic centers participating in the trial are all members of The Alzheimer's Disease Cooperative Study (ADCS). The involvement of the ADCS and NIH in the conduct of the Phase III trial ensures the highest level of independent scientific evaluation of the potential role of IVIg in the treatment of Alzheimer's disease patients.
