Oxygen Therapy Inc.’s drug OTI-629 is designed to oxygenate ischemic (reduced blood flow) regions in the brain that suffered from hypoxia during a brain stroke. To minimize irreversible damage to the brain, it may be administered prior to current available treatments such as rt-PA and possibly have a positive confounding effect on the outcome. The new chemical drug OTI-629 is a modified hemoglobin structure, bound to a proprietary co-polymer structure. This new chemical structure offers significant improvement over all other previous hemoglobin-based oxygen carrier (HBOC) structures, because OTI-629’s unique co-polymer construct acts as the main carrier of oxygen, instead of the hemoglobin. Consequently, the new hybrid molecular construct substantially reduces methemoglobin formation and nitric oxide scavenging that may contribute to a variety of disorders—such as renal failure, vasoconstriction, hypertension, myocardial infarction, and related toxicity issues.
Furthermore, OTI-629’s small size, roughly 1/5,000th that of a red blood cell, enables it to perfuse constricted, ischemic capillaries that are inaccessible to red blood cells due to clots or other obstructions. The new molecule is stable in solution for 3 years at 250 C. and can be freeze-dried (lyophilized) for an even longer shelf life.
The starting material for making the product is bovine blood, collected from cows. It undergoes a process of multiple separation techniques, including filtration, diafiltration, centrifugation, chromatography, and ultrafiltration, followed by polymerization and fractionation for sizing, including unique co-polymer reaction steps, ending with a sterile fill and finish step. To monitor the reproducibility and stability of the process, several analytical methods are used to measure the impurities profile, endotoxins, and bio burden, as well as a product quality assay.