Sigyn Therapeutics Announces Successful Completion of Animal Pilot Study
July 29, 2021 at 10:05 am
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Sigyn Therapeutics, Inc. announced the completion of a pilot animal study that validated the feasibility of a clinical protocol that resulted in the safe administration of Sigyn Therapy™ during six-hour treatment exposures. The pilot study represents the first-in-mammal use of Sigyn Therapy in a clinical setting. Sigyn Therapy is a novel blood purification technology designed to overcome the limitations of previous drugs and devices to treat life-threatening inflammatory conditions, including sepsis. The annual U.S. market opportunity to treat these indications exceeds $20 billion. In the pilot animal study, an adult version of Sigyn Therapy was administered to two porcine (pig) subjects (each ~ 40 kilos) to evaluate the feasibility of a therapeutic protocol designed to support subsequent clinical studies. In the study, Sigyn Therapy was deployed on a standard dialysis hardware system and utilized conventional blood-tubing set configurations. There were no treatment complications, adverse events or observations of hemolysis during the six-hour treatment procedures. Additionally, hemodynamics, blood gases and lab values were maintained within normal limits for the duration of each treatment. Based on the pilot study results, the company plans to treat up to eight additional porcine subjects, whose treatment outcomes will be included in an Investigational Device Exemption (IDE) that Sigyn Therapeutics is drafting for submission to the United States Food and Drug Administration (FDA) to support the potential initiation of human clinical studies.
Sigyn Therapeutics, Inc. is a development-stage company. The Company is focused on creating therapeutic solutions that address unmet needs in global health. The Company's product candidate, Sigyn Therapy, is a broad-spectrum blood purification technology designed to treat pathogen-associated inflammatory disorders. Its treatment indications include endotoxemia and inflammation in end-stage renal disease (dialysis) patients, sepsis (a cause of hospital deaths), community-acquired pneumonia (a cause of death among infectious diseases), and emerging pandemic threats. Sigyn Therapy is a single-use disposable device that is deployable on the global infrastructure of hemodialysis and continuous renal replacement therapy (CRRT) machines. The Company's development pipeline includes a cancer treatment system comprised of ChemoPrep to enhance the tumor site delivery of chemotherapy, and ChemoPure to reduce treatment toxicity and inhibit the spread of cancer metastasis.