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Failure Of Baxter's Trial Another Blow To Alzheimer's Treatment

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In yet another blow to a potential treatment for Alzheimer’s disease, Baxter International (BAX) said its late-stage clinical trial failed to meet its endpoints for “reducing cognitive decline and preserving functional abilities” for patients.

Like other treatments once they reach the third phase and a broader clinical trial with more patients, Baxter’s drug did not “indicate a statistically “significant difference in the rate of cognitive decline as compared to placebo.” Here’s a link to Baxter’s statement on the trials end.

Though Baxter’s biologic derived from plasma known as intravenous immuno globulin (IVIG) was seldom mentioned alongside other companies working on Alzheimer’s treatments like Pfizer (PFE), Merck (MRK), Johnson and Johnson (JNJ) and Eli Lilly (LLY), it was unique in that the product was already on the market. Gammagard is used primarily as an immune system booster and could have reached Alzheimer’s patients sooner given doctors could technically have prescribed it earlier.

But hopes for Alzheimer’s patients with moderate and mild disease are the latest to be dashed.

“We are will be discontinuing” all studies of Gammagard in Alzheimer’s patients, Baxter corporate vice president and president of Baxter’s bioscience business told analysts and investors in a brief 40-minute conference call this morning.  “We are evaluating our future approach.”

Last year at a major Alzheimer’s meeting, a report on “long-term stabilization of Alzheimer’s disease” showed four patients on Gammagard had no decline over three years in several key measures of cognition and daily function. That small trial caught the attention of the Alzheimer’s community and grabbed a headline in the New York Times about “hints (the) Drug can slow Alzheimer’s.”

Baxter researchers seemed perplexed at exactly what happened.

“There is a lot of hypothesis but there are a lot of question marks here as well,” Hantson said.