The Gut Microbiome
The gastrointestinal system contains a natural and widely varied microbial ecosystem, called the gut microbiome. Diet, exercise, disease, and many other factors affect the gut microbiome that can alter the balance of good and bad bacteria. Good gastrointestinal health is achieved by facilitating the growth of good bacteria while keeping bad bacterial growth in check. Elemental Iron supplements, such as Ferrous Sulfate, cause a shift in the gut microbiome causing bad bacteria to flourish and preventing good bacterial persistence.
BioFe™ has been specifically engineered to protect the balance of the gut microbiome, providing a natural biologic form of iron as a Ferritin:Iron complex much like mothers milk for an infant.
BioFe™ is the first product candidate from the Siderosorb™ technology platform; BioFe™ is comprised of Bakers/Brewers yeast with H-Ferritin, FTH1. The H-Ferritin protein/iron complex is an indispensable mammalian iron absorption, transport, and storage system that is delivered directly to the bloodstream from the intestine in the non-toxic, Fe+3, state. An illustrative example of the natural biology of the Ferritin/Iron complex is its presence in human breast milk, providing nursing infants the readily adsorbed iron required for rapid learning and development. BioFe™ provides stable, high level expression of the Ferritin protein that is complexed with iron during growth. BioFe™ is pasteurized and dried allowing its incorporation into a variety of formats for consumption. Alone, BioFe™ is pleasant tasting with a sweet, nutty flavor.
Sidero scientists have shown that BioFe™ is effective in two animal models of iron deficiency anemia (IDA). First, in a rat model of IDA, BioFe™ was found to be significantly more effective than the current standard-of-care, ferrous sulfate (FeSO4), at correcting serum iron and hemoglobin levels. Second, spontaneously anemic infant monkeys achieved normal serum iron and hemoglobin levels with just two weeks of BioFe™ treatment. Spontaneously iron deficient monkeys is a very good model of human iron deficiency. These primate experiments will continue with an ongoing $2.5M grant from the National Institutes of Health (NIH). Sidero has completed its first clinical trial of BioFe™ for the management of iron deficiency with exceptional results, which are currently being drafted for publication. A second clinical trial of BioFe™ is underway.
We are currently preparing several scientific publications to present many additional novel and exciting findings.