baxter international inc (BAX) Snapshot

Baxter International Inc. Presents at Goldman Sachs 34th Annual Global Healthcare Conference, Jun-11-2013 02:40 PM. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.

To discuss Topline results of phase III study of Immunoglobulin for Alzheimer's disease

Baxter International Inc. announced that its Phase III clinical study of immunoglobulin (IG) did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease. The Gammaglobulin Alzheimer's Partnership (GAP) study was conducted by Baxter in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), a clinical trial consortium supported by the United States National Institute on Aging in the National Institutes of Health. Topline analyses from the randomized, double-blind, placebo-controlled, multi-center trial found that after 18 months of treatment, patients with mild to moderate Alzheimer's disease taking Baxter's IG treatment at either the 400 mg/kg or the 200 mg/kg dose did not demonstrate a statistically significant difference in the rate of cognitive decline as compared to placebo (mean 7.4 in the 400 mg/kg group, 8.9 in the 200 mg/kg group, and 8.4 in the placebo group). Results also did not indicate a statistically significant change in functional ability as compared to placebo (mean -11.4 in the 400 mg/kg group, -12.4 in the 200 mg/kg group, and -11.4 in the placebo group). While the study was not powered to show statistical significance among the sub-groups, in the pre-specified sub-group analysis, the 400mg/kg treatment arm showed a positive, numerical difference in change from baseline versus placebo in cognition as measured by the Alzheimer's Disease Assessment Scale -- Cognitive Subscale (ADAS-Cog) and Modified Mini-Mental State (3MS) Examination among both moderate patients and carriers of the ApoE4 genetic marker. These differences ranged between 16% and 29%. IG was well tolerated in the study and no new safety signals were identified associated with treatment in this patient population, ages 50-89. The most common adverse reactions (observed in at least 5% of patients) during treatment with IG were rash and decreases in hemoglobin. There were no differences in the rate of thromboembolic events in the treated groups versus placebo groups. There were 17 serious adverse reactions considered to be treatment-related in the study (12 in the IG cohorts and five in the placebo cohort).