Saturday, November 07, 2020 2:37:05 PM
Qualigen Therapeutics Receives Positive Pre-IND Response from FDA for the Clinical Development of AS1411 as a Treatment for COVID-19
CARLSBAD, Calif., Oct. 28, 2020 /PRNewswire/ -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN) today announced receipt of written feedback to its Type B Pre-IND (Pre-Investigational New Drug application) meeting request from the U.S. Food and Drug Administration (FDA) 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.
.......
"We are delighted with the FDA's thoughtful and thorough response to our Pre-IND meeting request which provides a pathway for us to move forward with filing the IND application and initiation of a clinical trial in the first half of calendar 2021," stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "We are in agreement with the FDA's additional recommendations and believe their responses provided the clarity needed to move forward to get AS1411 into clinical trials for the treatment of hospitalized patients with COVID-19. In addition, we look forward to further investigating the potential use of AS1411 as a broader spectrum antiviral therapeutic."
https://ir.qualigeninc.com/news-events/press-releases/detail/38/qualigen-therapeutics-receives-positive-pre-ind-response
https://ir.qualigeninc.com/news-events/press-releases/detail/39/qualigen-therapeutics-engages-sta-pharmaceutical-as-gmp
A second example:
"WESTMINSTER, CO / ACCESSWIRE / August 12, 2020 / ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced it has completed a pre-Investigational New Drug (IND) consultation with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP). The FDA provided feedback for ARCA's clinical development plans for evaluating AB201 as a potential treatment for patients with severe COVID-19. With this feedback, ARCA anticipates submitting its IND application in September 2020 in preparation for initiating a Phase 2B clinical trial as early as the fourth quarter of this year."
https://www.accesswire.com/601279/ARCA-Biopharma-Announces-Completion-of-FDA-Pre-IND-Consultation-Under-Coronavirus-Treatment-Acceleration-Program-for-AB201-as-a-Potential-Treatment-for-Severe-COVID-19
“I have had a wonderful time but this wasn't it.”
..........Groucho
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