No little attention in Alzheimer's research has focused on monoclonal antibodies to remove amyloid plaques from the brain. According to the amyloid hypothesis, amyloid plaques accumulate on brain cells, interfering with their function and killing them. These treatments to remove the plaques include aducanumab and donanemab, but the jury is still out on their effectiveness. So now a stem cell treatment is gaining new attention following positive results from its phase I trial.
The treatment is called Lomacell-B, and was it developed by a company named Longeveron in Miami, Florida. It has been found safe in earlier trials for use as a treatment for other conditions, both in children and the elderly. It has just completed its phase I trial for use with mild Alzheimer's disease, and the results are quite promising. The primary purpose of a phase I trial is to demonstrate safety, but they also look for effectiveness of the treatment. Phase I trials usually involve few participants, and the results are subject to misleading statistical vagaries.
This treatment uses stem cells derived from bone marrow of young, healthy donors. For the trial, it was administered in a single infusion, and results were measured over a year. There were three groups of test subjects: one receiving a high dose, one receiving a low dose, and one receiving a placebo.
Longeveron announced the results of the phase I tests on April 13 in this press release. We have come to expect that attention on a new Alzheimer's disease treatment will cause the sponsoring company's stock to jump, but that hasn't happened with Longeveron. I don't know why, but there are a lot of factors that go into pricing a stock, and this company is tiny. It doesn't help that they've been losing money year over year for a while.
As with the monoclonal antibodies, Lomacell-B is not a cure, but it does appear to slow the progress of Alzheimer's disease in its earlier stages. Longeveron is claiming that it appears to reduce Alzheimer's disease-associated brain inflammation, improve the function of blood vessels in the brain, reduce brain damage due to disease progression, and promote regenerative responses.
I couldn't help noticing that these are similar to the effects we expect from the brain-derived neurotrophic factor (BDNF) generated during aerobic exercise. We discussed this in Beating the Dementia Monster, noting that BDNF is understood to prompt stem cells in the hippocampus to form new neurons.
Longeveron hopes to launch a phase II study later this year.
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