Sigyn Therapeutics, Inc. Reports the Successful Completion of A Study to Address Gram-Positive Bacterial Toxins Associated with Sepsis
December 01, 2021 at 06:00 pm IST
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Sigyn Therapeutics, Inc. announced that preclinical invitro studies have validated the ability of Sigyn Therapy to deplete the presence of gram-positive bacterial toxins from human blood plasma. Sigyn Therapy is a dual-function blood purification technology that extracts pathogen sources of life-threatening inflammation in concert with the broad-spectrum elimination of inflammatory mediators that fuel sepsis, the leading cause of hospital deaths worldwide. Candidate pathogen-associated indications for Sigyn Therapy include but are not limited to the treatment of emerging bioterror and pandemic threats, drug-resistant pathogens, hepatic encephalopathy, and community-acquired pneumonia, which is the leading cause of death among infectious diseases, the leading cause of death in children under 5 years of age, and a catalyst for ~50% of sepsis and septic shock cases. In the bacterial toxin study, the Company is reporting that clinically relevant levels of the gram-positive bacterial toxins peptidoglycan (PG) and lipoteichoic acid (LTA) were infused into 1000ml of human blood plasma and circulated through an adult version of Sigyn Therapy at normal treatment blood-flow rates. The invitro clearance of both targets was rapid, with an ~50% reduction of PG at one hour and a ~70% reduction of LTA at two hours. In addition to being potent activators of sepsis, there is a heightened interest in gram-positive pathogens based on the continuing emergence of drug resistant species, including antibiotic-resistant Staphylococcus aureus (MRSA). The data resulting from the study will be incorporated into an Investigational Device Exemption (IDE) that the Company is preparing for submission to the United States Food and Drug Administration (FDA) to support the 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.