Boston’s Brigham and Women’s Hospital announced Tuesday that it would test a nasal vaccine for Alzheimer’s disease.
The hospital released a press statement saying that the move is the culmination 20 years of research at their institution.
“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” Dr. Howard Weiner, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, said in a statement. “If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s in people at risk.”
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The intranasal vaccine’s first human clinical trial is underway. It is designed to slow down the progression of the disease.
Weiner discussed Alzheimer’s disease in an interview with Fox News. He said that people in their 50s or 60s who have no symptoms are developing the disease.
“Understanding the mechanism of Alzheimer’s … you have these toxic substances in the brain: amyloid, tau, other things like that. As we age, our immune system often fights these things off. As we age, our immune system becomes less efficient at fighting off these diseases. And through a whole series of experiments, we discovered that we could give a nasal vaccine – which is actually a type of bacteria that’s used in other vaccines – and it stimulates the immune system and then the cells go into the brain and fight against the disease,” he explained. “So, we’ve been working hard on this.” [for]It took a while. A lot of challenges – understanding the mechanism, how to manufacture it, working with the FDA – and we finally made it.”
The vaccine uses Protollin, an intranasal agent used to stimulate the immune system.
Protollin, which is composed of proteins derived from bacteria, has been safe used in humans. It activates white blood cell receptors in the lymph nodes at the sides and backs of the neck, causing them to migrate to brain to clear beta-amyloid plaques.
Jiangsu Nhwa Pharmaceutical and I-Mab Biopharma (I-Mab), who are responsible for the development and manufacturing of Protollin, funded the study.
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The trial will study 16 people between the ages of 60 and 85 with early, symptomatic Alzheimer’s, and all participants will be enrolled from the Ann Romney Center.
Patients must have undergone an amyloid-positive PET scan, and must be in good health.
Weiner said that blood testing will be performed to determine which dose stimulates immune system the most. “This will last approximately six months, and then there’ll be a trial for 150 patients that will be treated over the next year. We’re currently only getting two doses per week. And then, the next trial when we treat 150 patients, they’ll be treated for a year probably getting it once a month … That’s what we’re aiming toward.”
The Phase I trial’s objective will be to determine the safety and tolerability of the nasal vaccine, in addition to measuring the effect of nasal Protollin on participants’ immune response, including its effects on white blood cells.
Weiner wrote that the immune system plays an important role in all neurologic disorders. “And it’s exciting that after 20 years of preclinical work, we can finally take a key step forward toward clinical translation and conduct this landmark first human trial.”
Source: Fox News