29 October 2020 - - US-based biotechnology company Qualigen Therapeutics, Inc. (NASDAQ: QLGN) has received written feedback to its Type B Pre-IND (Pre-Investigational New Drug application) meeting request from the US Food and Drug Administration that is in general agreement with the company's planned clinical development of AS1411, a nucleolin-targeting DNA aptamer drug candidate, for the treatment of COVID-19, the company said.

The FDA's response solidifies Qualigen's intention to reprioritize its clinical development program and to first advance AS1411 into clinical trials (for treatment of COVID-19) in the first half of calendar 2021, to be followed next by seeking to advance ALAN into clinical trials against acute myeloid leukemia.

ALAN is AS1411 attached to a gold nanoparticle.

In its Pre-IND meeting request, the company requested regulatory guidance on its planned randomized, multicenter study to evaluate the safety and efficacy of AS1411 in hospitalized patients with COVID-19.

The FDA's recommendation is to commence with a Phase 2a proof-of-concept study to evaluate safety and initial efficacy in determining the appropriate dose with outcomes assessed at Day 28.

The company and the FDA agree that a Phase 1 clinical trial is not needed here, because in a previous clinical trial against cancer AS1411 has already been shown to meet Phase 1 safety requirements.

Extensive preclinical research conducted at the University of Louisville has demonstrated that AS1411 has potent anti-viral activity against SARS-CoV-2 infection, the novel coronavirus responsible for COVID-19.

Qualigen has held an exclusive license to AS1411 since 2018, and in June 2020 Qualigen entered into an exclusive license agreement for the University of Louisville's pending US patent for the use of AS1411 for inhibiting or treating COVID-19.

Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for almost 20 years.

The company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects.

The foundational aptamer of ALAN, AS1411, is also being studied for use in treating or even preventing viral-based infectious diseases, including COVID-19.

RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes' proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers.

STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds.

Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world.

The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men's health, hormone function, vitamin D status and antibodies against SARS-CoV-2.

Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC.