Novel Cartridge Design for Whole Blood Purification
Since its inception, the Qualigen’s initial R&D focus has been on its FastPack diagnostic system and related core technologies. These same technologies are now the basis for the Company’s expansion into therapeutic applications for the treatment of cancer and infectious disease. Qualigen’s Selective Target Antigen Removal System (STARS), is an investigational therapeutic device product currently under development and evaluation that will utilize core expertise in advanced reagents and coatings to remove disease associated agents directly from a patient’s blood. The key components of STARS, membranes coated with target capture reagents, utilize several proprietary processes developed and used in the FastPack product lines. Proprietary STARS cartridges will be designed for use with conventional dialysis or hemofiltration machines to treat patients with various cancers; to remove immune checkpoints, metastatic cells, and inflammation factors. STARS could also be used to treat infectious diseases by removing circulating viruses sufficiently to facilitate patient stabilization and recovery.
Next Generation Cartridge as Treatment for Sepsis in Hospitalized Patients
Extracorporeal blood purification (EBP) is used to treat sepsis, including septic shock, the leading cause of death in ICU settings with an over 40% mortality rate. Death typically occurs from multiple organ failure driven by an increase in complement protein and cytokine production in response to endotoxin levels, particularly LPS, from bacteria or viruses circulating in the blood. Utilizing continuous renal replacement support devices in the ICU, EBP cartridges often incorporate a proprietary resin, fiber, or beads or a proprietary capturing agent such as a peptide or chimeric protein. Cartridges are Class IIa/b medical devices and are used for 1-2 hours per treatment, once or twice a day at $1,000 to $2,000 per cartridge. Despite a growing list of CE marked devices, there are no FDA approved cartridges for septic shock, although vasopressors and antibiotics are administered.
STARS is wholly owned by Qualigen Therapeutics under US patent 10,744,258, issued August 2020, describing devices and methods for on-line whole blood treatment. Additional PCT national entry countries pending.
- Works for a capturing reagent that gets saturated
- Regenerate without changing the column for capturing reagents with (1:1) stoichiometric dynamic, including antibodies
- Good for depleting highly concentrated antigenic targets from blood
- Use less column per treatment, limited the need to replace columns
- Protected by PCT application, wholly owned by Qualigen Therapeutics