Pharmacology
 
· The steady concentrations of SOD in the three blood fractions (plasma, red and white blood cells) varies with the but is associated with the individual’s overall health.
 
· Animal pharmacokinetics studies indicate that the circulating SOD level in RBC progressively increases from the first hour after GliSODin® administration, with a dose independent maximum at 12 hours. The return to the baseline level is obtained after 24 h.
 
· In a small human study, 400 mg of GliSODin® administration appeared to demonstrate the bioavailability profile of the product. The antigenic nature of GliSODin® is an important factor. SOD levels are tabulated here.


Healthy volunteers Placebo GliSODin® (2 x 200 mg)
MS TT YM SH KH JF TM 47.7 140.8 64.2 115.2 127.3 140.0 102.6 224.2 84.9 223.1 182.4 172.9 80.0 128.9
 
These data suggested that the GliSODin® product reached the intestinal tract intact and acted as a SOD-normalizer or more probably as an anti-oxidant-normalizer in healthy people. More extensive human trials are currently underway which will more definitively measure the effect on blood SOD levels of GliSODin® oral administration.
 
· The proposed detailed mechanism of action: Oral GliSODin® is absorbed at the level of the small intestine via enterocytes and/or M cells and then is presented to the innate mucosal immune system mainly by macrophages and dendritic cells, finally polarizing the adaptive and specific immune system to produce cytokines and antibodies that will propagate the SOD-protective effect to the overall organism likely via the lymphatic network.

· Limited human studies (skin fibrosis, loss of cognitive functions etc.) indicate that this GliSODin® should be further evaluated considered as add-on therapy to usual conventional drug treatment. GliSODin® seems to promote the therapeutical effects of various drugs -including certain chemotherapeutic drugs- while at the same time significantly reducing the drugs’ toxicity.