Baxter International Inc. (BAX) recently produced encouraging results of its 18-month Phase II clinical study of GAMMAGARD LIQUID and GAMMAGARD S/D (Immune Globulin Intravenous [Human]) for mild-to-moderate Alzheimer’s disease. The clinical trial measures three key parameters: cognitive, functional and neuroimaging. All these parameters produced positive data.
The Phase II clinical study enrolled 24 patients in the U.S. with mild-to-moderate Alzheimer’s disease. They were randomly assigned to receive GAMMAGARD (16 patients) or saline placebo (8 patients) for six months. After six months, eight patients who were initially receiving placebo were given various doses of GAMMAGARD. The other sixteen were given GAMMAGARD uninterrupted for 18 months.
The functional parameter was measured by the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change rating (ADCS-CGIC) and cognitive was measured using the Alzheimer’s Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog).
Clinical data indicated that on the ADCS-CGIC scale, patients who received GAMMAGARD continuously for 18 months averaged roughly 1.36 points higher than patients who initially received placebo. On the ADAS-Cog scale, patients who received GAMMAGARD continuously for 18 months averaged approximately 9.15 points lower than patients who initially received placebo. These data are encouraging for Baxter.
In addition, the clinical data indicated that patients who received GAMMAGARD continuously for 18 months experienced lower mean annual ventricular enlargement rates in their brains and lower mean annual whole brain atrophy rates, compared to patients who initially received placebo.
The encouraging data prompted Baxter to initiate a second, concurrent Phase III study of GAMMAGARD on more patients. Baxter is already running a Phase III study of GAMMAGARD, known as the Gammaglobulin Alzheimer’s Partnership (GAP) Study.
Baxter is a leading global medical products and services company that develops, manufactures and markets products for treating hemophilia, kidney disease, infectious diseases, etc. Baxter’s main competitors include Becton, Dickinson and Company (BDX) and Johnson & Johnson (JNJ). Presently, we have a Neutral recommendation for Baxter.