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China conditionally approves drug derived from brown algae for Alzheimer's disease
Here is part of the story:
China’s National Medical Products Administration granted conditional approval to the drug Oligomannate (GV-971), the regulator said in a statement on its website.
Shanghai Green Valley Pharmaceuticals said in a separate statement the drug received the regulator’s approval for treatment of "mild to moderate Alzheimer’s disease and improving cognitive function," following a Phase 3 clinical trial in China.
“Trial results demonstrated that Oligomannate statistically improve cognitive function in mild-to-moderate AD patients as early as week 4 and the benefit was sustained at each follow-up assessment visit,” the company said.
It said it expects the drug to be available in China by early 2020 and plans to apply for marketing authorization in "selected countries following the China launch." It plans a multi-center global Phase 3 clinical trial with sites in the U.S., Europe and Asia starting early next year to support those filings.
The drug is a low molecular acid oligosaccharide compound extracted from marine brown algae, according to the Chinese regulator’s statement. The regulator said it requires further studies on the drug’s pharmacology, safety and effectiveness after it’s launched to the market.
I have been looking for a mechanism of action for this drug and this is the best that I have found so far:
Alginate from marine brown algae has been widely applied in biotechnology. In this work, the effects of alginate-derived oligosaccharide (AdO) on lipopolysaccharide (LPS)/β-amyloid (Aβ)-induced neuroinflammation and microglial phagocytosis of Aβ were studied. We found that pretreatment of BV2 microglia with AdO prior to LPS/Aβ stimulation led to a significant inhibition of production of nitric oxide (NO) and prostaglandin E₂ (PGE₂), expression of inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2) and secretion of proinflammatory cytokines. We further demonstrated that AdO remarkably attenuated the LPS-activated overexpression of toll-like receptor 4 (TLR4) and nuclear factor (NF)-κB in BV2 cells. In addition to the impressive inhibitory effect on neuroinflammation, we also found that AdO promoted the phagocytosis of Aβ through its interaction with TLR4 in microglia. Our results suggested that AdO exerted the inhibitory effect on neuroinflammation and the promotion effect on microglial phagocytosis, indicating its potential as a nutraceutical or therapeutic agent for neurodegenerative diseases, particularly Alzheimer's disease (AD).
Inhbiting inducible nitric oxide synthase also inhibits the formation of peroxynitrite which is likely responsible for much of the damage done to the brain in Alzheimer's disease.
Deficiency of iNOS substantially protected the AD-like mice from premature mortality, cerebral plaque formation, increased beta-amyloid levels, protein tyrosine nitration, astrocytosis, and microgliosis. Thus, iNOS seems to be a major instigator of beta-amyloid deposition and disease progression. Inhibition of iNOS may be a therapeutic option in AD.
Maybe this actually works.
A link to the trial results:
Better yet in terms of mechanism:
Alginate oligosaccharide (AOS) has recently demonstrated the ability to protect against acute doxorubicin cardiotoxicity and neurodegenerative disorders by inhibiting oxidative stress and endoplasmic reticulum (ER) stress-mediated apoptosis...With regard to mechanism, AOS pretreatment markedly attenuated nitrative/oxidative stress, as evidenced by decreases in 3-nitrotyrosine content and superoxide generation, and downregulated inducible nitric oxide synthase...
China has approved seaweed-based drug called Oligomannate to treat mild to moderate Alzheimer’s and improvement can be seen in cognitive function in as little as four weeks.
Seaweed is a standard in Asian cuisine, available at health food and bulk food stores. A tad salty.
So I was reading about early travels to Asia to buy spices, yet I don't think I actually use those spices in everyday life. The first medicines were...food.
In the Alzforum article, if you look at the graph of the test scores, both the treatment and placebo groups improved up to 24 weeks, but then between 24 weeks and 36 weeks, the treatment group improved and the placebo group declined. Why did the improvements and declines occur in the same time interval? The improvements weren't great but they were statistically significant.
I have to wonder how carefully the Chinese government is supervising this trial. If this treatment were trialed by the FDA in the US and by governments in Canada and the EU, would they come up with simular positive results? Time will tell.
I don't think this drug can be legally imported into the US without going through a FDA clinical trial unless the FDA makes a special exception. Meanwhile expect to see a lot of all-natural seaweed products claiming to be just like this drug popping up in health food stores everywhere. Who knows what they will contain?