{"id":380881,"date":"2020-11-13T09:03:35","date_gmt":"2020-11-13T14:03:35","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=380881"},"modified":"2020-11-13T09:03:35","modified_gmt":"2020-11-13T14:03:35","slug":"qualigen-therapeutics-issues-ceo-letter-to-stockholders-reports-on-significant-progress-and-fiscal-second-quarter-financial-results","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/qualigen-therapeutics-issues-ceo-letter-to-stockholders-reports-on-significant-progress-and-fiscal-second-quarter-financial-results\/","title":{"rendered":"Qualigen Therapeutics Issues CEO Letter to Stockholders, Reports on Significant Progress and Fiscal Second Quarter Financial Results"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n CARLSBAD, Calif.<\/span>, Nov. 13, 2020<\/span> \/PRNewswire\/ —\u00a0Qualigen Therapeutics, Inc. <\/b>(Nasdaq: QLGN) announces\u00a0that Michael Poirier<\/span>, President, Chief Executive Officer and Chairman, has issued a letter to Qualigen’s stockholders. The full text is as follows: <\/p>\n

To My Fellow Stockholders,<\/p>\n

Since our last business update in August, Qualigen Therapeutics has made significant progress in advancing our strategic plan, including the following highlights:<\/p>\n

\n AS1411. <\/b>We are excited to be moving forward with our lead compound AS1411, a nucleolin-targeting DNA aptamer drug candidate for the treatment of COVID-19 and other viruses. Preclinical research conducted at the University of Louisville<\/span> (UofL) has demonstrated that AS1411 has potent antiviral activity against SARS-CoV-2, the coronavirus responsible for COVID-19. \u00a0Importantly, we believe AS1411 holds potential as a broad antiviral therapeutic agent, which could significantly expand its applications and commercial potential. <\/p>\n

In October 2020<\/span>, we received a positive response to our Pre-Investigational New Drug (Pre-IND) application meeting request from the U.S. Food and Drug Administration (FDA) that is in general agreement with our planned clinical development of AS1411 for the treatment of COVID-19. We are pleased with the FDA’s response and plan to move forward with filing the IND application in order to initiate a Phase 2a clinical trial in the first half of calendar year 2021.<\/p>\n

Like everyone else, we are heartened by news of recent advancements with COVID-19 vaccines; however, we believe there will still be a long-term and significant market opportunity for innovative therapies such as AS1411 to treat COVID-19 and other viral-based respiratory diseases.\u00a0 Furthermore, we believe that the urgency placed on regulators to advance potential therapies for COVID-19, in addition to vaccines, may provide us an accelerated path to potential approval of our first drug candidate. The data and infrastructure resulting from this may, in turn, serve to streamline subsequent clinical trials for additional indications for AS1411 to combat other viruses, both currently known and those that might affect us in the future.\u00a0 \u00a0\u00a0<\/p>\n

In this regard, we entered into manufacturing agreements with STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, and with IRISYS LLC in order to ensure adequate supply of AS1411 for our anticipated clinical trials. We believe that if AS1411 is approved by the FDA for commercial usage, these manufacturing agreements will help assure an efficient and large-scale rollout of this product.<\/p>\n

Finally, to further enhance our AS1411 intellectual property portfolio, we jointly filed a U.S. provisional patent application entitled “Methods of inhibiting or treating coronavirus infection, and methods for delivering an anti-nucleolin agent” with UofL. \u00a0If AS1411 can successfully serve as a protective defense (or prophylaxis) against, as well as treat, COVID-19 or other viral-based diseases, such as seasonal influenza, this would be a very exciting usage for our technology.\u00a0 We believe that for use as a prophylaxis, AS1411 could be administered by means of inhalers, nose spray or eye drops to individuals who have recently come in contact with SARS-CoV-2, or are at high risk of contracting the virus. \u00a0<\/p>\n

\n ALAN, RAS-F and STARS\u2122. \u00a0<\/b>The balance of our therapeutic pipeline primarily focuses on fighting cancer, and we continue to make progress with each of our drug and device candidates. <\/p>\n