Oxygen xml author 18.0.3/10/2023 ![]() The results of this study demonstrated that TSC was safe and well tolerated with a maximum tolerated dose of 2.5 mg/kg. The safety and tolerability of TSC was first clinically evaluated in a placebo-controlled Phase 1 study enrolling 40 normal healthy subjects ( 15). TSC was also shown to enhance radiosensitivity in a glioblastoma multiforme (GBM) model in rats ( 16), and to improve survival in a rat model of hypoxemia ( 17). Several studies were performed in various ischemic animal models where TSC was administered following ischemic shock, and these studies demonstrated significant improvement in survival rates of rats recovering from post ischemic shock ( 12– 15). Following these in-vitro experiments, in-vivo studies were performed to assess the potential of TSC as a therapeutic intervention in animal models of hypoxia. In-vitro studies have shown that TSC increases oxygen diffusion in water by up to 30% ( 8, 9). This enhances the organizational matrix within plasma, which facilitates the passive diffusion of oxygen from high to low concentration areas with less resistance ( 6, 7). Hypoxia is present in nearly all solid tumors and has been shown to contribute to resistance to radiotherapy, chemotherapy, and immunotherapy, as well as increase the potential for tumor invasion and metastasis ( 5).ĭiffusion Pharmaceuticals has developed trans sodium crocetinate (TSC), a fully synthetic trans-isomer salt of crocetin that has demonstrated the ability to increase the diffusion of oxygen by transiently increasing hydrogen bonds between water molecules within the plasma component of blood ( 4). In addition, hypoxia can often complicate many sub-acute conditions, such as with many cancers ( 6). Stroke, myocardial infarction, COVID-19 are just some examples of conditions complicated by hypoxia, for which hypoxia directly contributes to short- and long-term morbidity and mortality. ![]() When local, regional, or generalized oxygen delivery to tissues is either inadequate or disrupted, cells become hypoxic if not reversed, hypoxia can rapidly lead to tissue damage and cell death ( 1). demonstrated that crocetin, a natural carotenoid compound, was able to increase the diffusion of oxygen through plasma ( 3, 4). Convective delivery of oxygen is primarily driven by cardiac output and arterial oxygen content, while the diffusive transport occurs at the microcirculatory level and is dependent on Fick’s Law of diffusion, therefore representing a rate limiting step ( 2). ![]() Delivery of oxygen to tissues is dependent on both convection and diffusion. ![]() Oxygen is essential in mammals for aerobic metabolism and therefore the proper delivery of oxygen to tissues is vital ( 1). ![]()
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