The following are results of comparative experiments done on a subcomponent of the products tested in the peer-reviewed publication, A novel anti-inflammatory treatment for bradykinin-induced sore throat or pharyngitis. A smaller set has been chosen here for simplicity and due to limited space. In these experiments human respiratory cells were first exposed to the inflammatory agent bradykinin, and then treated with various leading cold products, in addition to Biovanta. The key biomarkers of all the cell lines were then compared to normal, untreated and healthy respiratory cells.
Inflammation and pain are well documented cold symptoms that can be directly measured. Biomarkers for inflammation and pain measured up to 48 hours after viral stimulation indicate the body’s inflammatory response. The following are the results of a blind randomized placebo-controlled study measuring prostaglandin (E2) in human respiratory cells. The main function of prostaglandin is to trigger the immune inflammatory response when under siege by pathogens. In measuring the health of cells, the amount of prostaglandin can be used as a precise biomarker for inflammation, irritation and pain, or otherwise expressed as the symptoms of sore throat and cough. As shown below, Biovanta is ONLY product that eliminates upper respiratory inflammation due to viral infections while helping the respiratory system to recover.
Note, the levels of prostaglandin must pair with healthy respiratory cells. The products that show higher levels of prostaglandin are overly inflamed and those that show no prostaglandin are essentially dead.
Another key biomarker for inflammation is Interleukin-8 (IL8). IL8 is a chemokine that is involved in inflammation pathway, but though related to prostaglandin it has a slightly different role. In measuring the health of cells, the amount of IL8 can be used as a precise biomarker for irritation, pain and signaling for other cytokines to mediate. Elevated levels of IL8 often result in a cytokine storm with subsequent damage/death of cells. As demonstrated below, Biovanta demonstrates biomarker levels equivalent to healthy cells while leading OTC drugs display significantly elevated levels over 24 and 48 hours.
Note, IL8 levels fluctuate over time but their levels must be similar over 24 and 48 hours to healthy respiratory cells. The products that show higher levels of IL8 have inflammation, while those that do not secrete IL8 are effectively dead.
The chart below is an assessment of cell integrity by way of TEER (Transepithelial Electrical Resistance, ohm/cm2) showing electric resistance levels across the cell wall. Essentially the cells that measure below the healthy threshold marked by dotted lines, are perforated. Those above the threshold are healthy and have maintained strong cell integrity. Out of the entire group, Biovanta is the only product that brings the health of the respiratory cells to normal levels.
The following is a test of Lactate Dehydrogenase (LDH) levels, a distress signal released when a cell is damaged or destroyed (toxicity). As one can clearly see below Biovanta is the only product that maintains low LDH levels.
Applied Bio is currently conducting clinical trials in support of a new drug application (NDA) for the claim of shortening duration of the common cold, an indication unique to the category for OTC monograph drugs.