By Allan Maurer
SARASOTA, FL—A promising new drug being tested by the Roskamp Institute showed positive results in preventing the onset of Alzheimer’s disease in patients with memory problems in a small, independent Japanese clinical study.
The study, which suggests the drug, Nilvadipine, can prevent the onset of Alzheimer’s disease in patients with memory problems, is detailed in the International Journal of Geriatric Psychiatry, a highly prestigious medical research journal.
The Institute says a spin-off company, Archer Pharmaceuticals, will likely be formed early next year to take the drug through larger clinical trials and commercialize it.
The Roskamp Institute owns worldwide rights to the drug Nilvadipine, an anti-hypertensive medication currently unavailable in the United States, which stabilized memory loss in eight patients randomly allocated the drug in a 20-month study at the Tokyo Medical University.
“Although the study was conducted with a small sample size, this third- party validation is extremely encouraging, as there appears to be a strong protective effect from developing Alzheimer’s in memory-troubled patients who were given Nilvadipine,” said Dr. Michael Mullan, director of the Roskamp Institute, who has been researching the drug for its use in Alzheimer’s disease.
The Roskamp Institute has been conducting its own human clinical study in partnership with the Trinity College Institute of Neuroscience in Dublin, Ireland, and has recently reported in March that the use of the drug in Alzheimer’s patients is receiving positive safety reviews.
Clears memory-sapping proteins
Mullan tells Techjournal South the drug appears to work by increasing clearance of the brain-clogging amyloid proteins-thought responsible for Alzheimer’s-from the brain to the blood.
“In animal models, that’s what happens,” he says.
Also in animal models, the drug works in both early and late stages of the disease, reducing the fibruous amyloids. “But we don’t know if that late stage effect will extrapolate to humans,” Mullan cautions.
Roskamp plans a larger Phase II study with about 200 patients. “If we see the same memory stabilization, it will be terrific,” says Mullan.
The work is currently funded by the institute, which plans to spin-off a company called Archer Pharmaceuticals early next year to commercialize the drug as it goes into later clinical trials. The new company will be looking for funding.
Mullan says hopes are the drug will be granted an innovative new drug application approved by the U.S. Food and Drug Administration by the first or second quarter, 2008. Then it will need a six-month Phase II trial to test efficacy.
The Roskamp Institute is a not-for-profit research Institute located in Sarasota and Tampa, Florida, that is dedicated to understanding the causes of, and finding cures for, neuropsychiatric and neurodegenerative disorders and addictions with an emphasis on Alzheimer’s disease.
The Roskamp Institute is looking for volunteers who have been diagnosed with Alzheimer’s disease or Multiple Sclerosis to participate in Roskamp’s ongoing research studies. If you or someone you know is interested in participating, pcontact its Clinical Trials Division at (941) 256- 8018.
On the Web: www.roskampinstitute.com
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