A Broad-Spectrum Opportunity to Address Life-Threatening Inflammatory Conditions
Cytokine Storm Syndrome underlies a wide range of infectious and non-infectious disease conditions that are not addressed with anti-cytokine drugs. The potential therapeutic opportunities for Sigyn Therapy include, but are not limited to sepsis, virus-induced Cytokine Storm (VICS) underlying COVID-19 and other virulent infections, bacteria-induced Cytokine Storm (BICS), acute respiratory distress syndrome (ARDS) and acute forms of liver failure, including hepatic encephalopathy. We also believe there is an opportunity for Sigyn Therapy to stabilize or extend the life of patients waiting for the identification of a matched liver for transplantation. In such a scenario, Sigyn Therapy is proposed to serve as a bridge-to-liver transplant.
Our Strategy To Calm the Cytokine Storm
To calm the Cytokine Storm, we designed Sigyn Therapy to deplete the presence of inflammatory cytokines, cytokine aggregates, endotoxin and CytoVesicles from the bloodstream.
About Inflammatory Cytokines & Cytokine Aggregates
Human cytokine production plays a central role to stimulate and regulate the innate and adaptive immune response to inflammation, trauma and infection. Cytokines represent a family of more than 100 different immunomodulation agents, which can exist in both peptide and protein forms. Included within the cytokine family are chemokines, interferons, interleukins, lymphokines and tumor necrosis factor. The excess production or dysregulation of inflammatory cytokines (Cytokine Storm Syndrome) has been demonstrated to play a role in the pathogenesis of a wide-range of life-threatening conditions, including septic shock and sepsis-associated organ dysfunction. Cytokine Aggregates result when two or more biologically active cytokines fuse together in the circulatory system.
Endotoxin resulting from bacterial infections is a potent driver of Cytokine Storm Syndrome and is associated with a wide range of antibiotic-resistant species. The extracorporeal elimination of circulating endotoxin has previously been demonstrated to help rebalance the innate immune system, decrease levels of inflammatory mediators, and improve vascular function and hemodynamics. Endotoxin is a primary activator of septic shock and multiple organ failure. Once in circulation, endotoxin induces the production of monocytes and macrophages that produce and release cytokines and other systemic mediators of life-threatening inflammatory conditions.
Beyond endotoxin and inflammatory cytokines, CytoVesicles transport a wide range of inflammatory cargos that participate in concert with freely circulating cytokines to promote both acute and chronic inflammatory disease conditions. We believe the simultaneous depletion of circulating cytokines, cytokine aggregates, endotoxinand CytoVesicles establish the basis for a first-in-industry approach to alleviate the symptoms or severity of a multitude of inflammatory disorders.
Sepsis Treatment Opportunity
The Leading Cause of In-Hospital Deaths
Sepsis is a life-threatening inflammatory condition that is precipitated by Cytokine Storm Syndrome. Sepsis is the leading cause of hospital deaths and kills more people around the world than all forms of cancer combined.
Virus Induced Cytokine Storm Treatment Opportunity
CurbingThe Life-Threatening Immune Response to Viral Infections
Sigyn Therapy is a candidate first-line countermeasure to mitigate virus-induced Cytokine Storm (VICS) that can result from a broad-spectrum of viral pathogens, including emerging pandemic threats such as COVID-19.
Bacteria Induced Cytokine Storm Treatment Opportunity
Rebalancing the Host Immune Response to Infection
Sigyn Therapy is a candidate to address bacteria-induced Cytokine Storm (BICS), a global health issue that may be initiated by antibiotic-resistant bacterial species and results in approximately 23,000 deaths each year.
Acute Respiratory Distress Syndrome Treatment Opportunity
Mitigating Widespread Inflammation in the Lungs
Cytokine Storm Syndrome contributes to the advancement of acute respiratory distress syndrome (ARDS), a form of respiratory failure characterized by widespread inflammation in the lungs.
Hepatic Encephalopathy Treatment Opportunity
A Strategy to Address Acute Liver Failure
Sigyn Therapy is a potential candidate to address acute forms of liver failure, including Hepatic Encephalopathy (HE), whose severity correlates with high concentrations of circulating toxins and inflammatory cytokines.
Bridge-To-Liver Transplant Opportunity
An Approach to Extend to Lives of Those Awaiting a Liver Transplant
We plan to evaluate Sigyn Therapy as a strategy to stabilize or extend the life of patients who are awaiting a liver transplant.
Other Potential Opportunities for Sigyn Therapy
Cytokine Storm Syndrome may also result from trauma, severe burns, acute pancreatitis, adverse drug reactions, cancer immunotherapies, cancer cachexia, acute kidney injury (AKI), and severe pneumonia.