Reporter: Aviva Lev-Ari, PhD, RN
A pivotal study of a third drug will end later this year, and results from a small, early test of it will be reported next week at an Alzheimer’s conference in Vancouver, British Columbia.
These three treatments are practically the “last men standing” in late-stage trials, after more than a decade of failed efforts to develop a drug to halt the mind-robbing disease. Current medicines such as Aricept and Namenda just temporarily ease symptoms. There is no known cure.
Experts say that if these fail, drug companies may pull out of the field in frustration, leaving little hope for the millions of people with the disease. An estimated 35 million people worldwide have dementia, which includes Alzheimer’s. In the U.S., experts say about 5 million have Alzheimer’s.
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http://www.timesleader.com/stories/Last-drugs-standing,176933
The three drugs and their developers are:
• Bapineuzumab (bap-ih-NOOZ-uh-mab), by Pfizer Inc. and Johnson & Johnson’s Janssen Alzheimer Immunotherapy unit.
• Solanezumab (sol-ah-NAYZ-uh-mab), by Eli Lilly & Co.- Antibody
• Gammagard, by Baxter International Inc. – IV Immune Globulin
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All are given as periodic intravenous infusions; some companies are trying to reformulate them so they could be given as shots. If a major study shows that one of the drugs works, there will be a huge effort to make it more convenient and practical, Thies predicted.
Still, it would probably be very expensive.
The first two on the list are lab-made, single antibodies against amyloid. Gammagard is intravenous immune globulin, or IVIG — multiple, natural antibodies culled from blood. Half a dozen companies already sell IVIG to treat immune system and blood disorders. It takes 130 plasma donations to make enough to treat one patient for a year.
Treating Alzheimer’s with IVIG would cost $2,000 to $5,000 every two weeks, depending on the patient’s weight, said Dr. Norman Relkin, head of a memory disorders program at New York-Presbyterian Hospital/Weill Cornell Medical Center. He consults for some drugmakers and has patents for tests that measure amyloid.
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Concern arose when an earlier study found possible bleeding or brain abnormalities in up to 10 percent of patients on the drug. However, most had no symptoms and were able to resume treatment after a brief break, Yuen said. In fact, some researchers think these changes might be a sign the drug is working to clear the amyloid plaque.
The fact that independent monitors have not stopped the new studies has made Dr. Reisa Sperling optimistic the drug will prove to be safe. Director of the Alzheimer’s center at Brigham and Women’s Hospital in Boston, she has consulted for Janssen and Pfizer and enrolled patients in the studies.
Relkin, who is leading the Gammagard study, said that if all three of these drugs fail, “we’re in trouble.” There hasn’t been a new drug even to help symptoms in nine years, he said.
Petersen of the Mayo Clinic agrees.
“If they’re dead-flat negative, the impact on the field and the implication for Big Pharma could be huge,” he said. Companies “may bail” from the field entirely. “They may just say, ‘This nut is too tough to crack.”’
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I’m not sure that the anti-amyloid treatment will succeed, but we’ll see. The amyloid appears to be the tail that wags the dog. IVIG is another use of a treatment used for myelofibrosis, with surprising success.
This is the magic bullet approach for a high profile and costly, debilitating disease. It may not be the end of the line, despite the concerns expressed.
The knowledge of the disease is being rapidly expanded.
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