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Find Clinical Drug Pipeline Developments & Deals for AS1411
FDA for Qualigen's QN-165 with an initial target indication for the treatment of COVID-19 in hospitalized patients. QN-165, a DNA aptamer, is a broad-based antiviral drug candidate that has exhibited antiviral activity in multiple in vitro assays against different viruses.
Qualigen has completed the recertification of its supply of AS1411, and has begun final formulation and filling for use in the Company's proposed Phase 2a efficacy trials of AS1411 for the treatment of patients with COVID-19.
Qualigen Therapeutics has signed a contract with STA Pharmaceutical, a subsidiary of WuXi AppTec, for GMP production of AS1411, Qualigen's lead drug candidate for the treatment of COVID-19 and other viral diseases, for potential clinical trials.
The FDA's response solidifies Qualigen's intention to reprioritize its clinical development program and to first advance AS1411 into clinical trials in the first half of calendar 2021, to be followed by seeking to advance ALAN into clinical trials against AML.
The application covers methods for using the antiviral drug candidate AS1411 to prevent SARS-CoV-2 (the virus that causes COVID-19) from entering the body through mucous membranes in the nose,
mouth and eyes.
Preclinical studies at the University of Louisville's (UofL) prestigious Center for Infectious Disease have demonstrated the ability of AS1411 to protect cells from the damaging effects of the novel coronavirus by binding to the nucleolin protein.
The new agreement provides a license under UofL's pending U.S. patent for the use of AS1411 for inhibiting or treating COVID-19. Qualigen has separately been developing ALAN as a drug candidate against cancer, under a previous technology license agreement with UofL.
Qualigen offers a number of revenue-generating therapeutic and diagnostic products that may help Ritter Pharmaceuticals to advance its pipeline and grow its business.