August 31, 2020 -- Qualigen Therapeutics has signed a contract with Irisys for the production of AS1411, Qualigen's lead candidate for the treatment of viral diseases including COVID-19.
AS1411 is a DNA-coated gold nanoparticle that targets and binds nucleolin, a protein that plays a role in how viruses attack and utilize cells for replication. Preclinical studies, conducted at University of Louisville's Center for Infectious Disease, showed that AS1411 protected cells from the damaging effects of SARS-CoV-2 by binding nucleolin.
In June 2020, Qualigen signed an exclusive license agreement with the university to complete investigational new drug-enabling studies with the U.S. Food and Drug Administration in the fourth quarter of 2020. The company intends to begin phase I/II clinical studies in COVID-19 patients early next year.
Irisys is a contract pharmaceutical product development and manufacturing organization headquartered in San Diego.