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[DewDiligence]

Baxter’s Gammagard Meets Goals in 9-Month AD Trial

[Gammagard is simply IVIG, a plasma-derived product marketed for immune-system disorders. The practical difficulties of turning this into a drug for AD have been discussed at length on this board; nevertheless, BAX plans to start a phase-3 trial soon with help from the NIH. Even if Gammagard proves to be impractical as a commercial drug for AD, the Gammagard trials may enable BAX to develop a derivative drug with comparable safety and efficacy and greater ease of production.]

http://www.reuters.com/article/healthNews/idUSN2931195720080730

›Jul 30, 2008
By Susan Kelly

CHICAGO, July 30 (Reuters) - Alzheimer's disease patients treated with Baxter International Inc's Gammagard for nine months maintained cognitive function and in some cases improved it, according to an interim analysis of data from a small study.

"If successful, it should actually alter the long-term course of the illness, and the effects should persist for a very long time," Dr. Norman Relkin, lead researcher for the study and a neuroscientist at New York-Presbyterian Hospital/Weill Cornell Medical Center, said in an interview on Wednesday.

Gammagard, an intravenous therapy of antibodies derived from human plasma that has been sold for other uses for 15 years, is intended to attack the disease in two ways.

The antibodies target beta amyloid proteins thought to disrupt brain function in Alzheimer's patients. Gammagard also contains anti-inflammatory properties that may activate microglia cells to help dissolve amyloid deposits, or plaques.

The 9-month data from the 24-patient phase-2 study were presented at the Alzheimer's Association conference in Chicago.

Six-month data from the study were released in April and deemed successful enough that the 8 patients who initially received a placebo were switched to Gammagard.

Patients treated with Gammagard for nine months showed significantly better cognitive and overall clinical outcomes than those who initially received a placebo, as measured by two commonly used disease assessment tests, the study found.

"The data so far show Gammagard has a sustained beneficial effect on maintaining cognitive functions," Dr. Hans-Peter Schwarz, vice president of global pre-clinical research and development at Baxter, said in an interview. "It prevents decline in cognitive function, and in some patients cognitive function actually improved."

More than 5 million people in the United States suffer from Alzheimer's disease, according to the Alzheimer's Association. The disease is marked by progressive deterioration of learning and language abilities, memory and fine-motor skills.

Patients taking currently approved Alzheimer's medicines tend to get a peak benefit in the first 3 to 6 months and then decline. Relkin said that what is exciting about the new Gammagard data is the sustained benefit seen through nine months.

Patients in the study will be followed for 18 months.

Gammagard patients' scores on two tests called the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (CGIC) met the study's primary goals, researchers said.

The Gammagard group at nine months averaged 1.5 points higher on the CGIC scale and 5.4 points higher on the ADAS-Cog scale than those who were on placebo for the first six months and on the drug for three, researchers said.

Patients who received Gammagard for nine months also performed better on a measure of ability to perform daily activities such as eating, grooming and operating common household appliances than those who initially received a placebo. The patients' skills either improved slightly or declined slightly, while patients initially on a placebo demonstrated a greater decline in skill levels.

No major adverse events were seen with the drug, which is approved to treat immune system disorders. There was a greater incidence of rash and of a transient drop in blood count in the drug group compared with the placebo group.

"There is a lot of experience with this product. There is an established safety record in all of the other indications for which the product is approved," Schwarz said.

Baxter is working with U.S. regulators to finalize the design of a larger, phase-3 trial, which will be co-sponsored by the National Institutes of Health and is expected to begin enrolling patients this year.‹


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