Peer-Reviewed Article Confirms That Qualigen’s FastPack® is as Accurate in Thyroid Stimulating Hormone Measurement -- and Much Faster -- Than a Leading Laboratory Method

CARLSBAD, Calif., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, today announces the publication of a study in the peer-reviewed, open-source journal, Diagnostics, validating the Company’s point of care FastPack^® IP (“FastPack”) diagnostic test as comparable to an industry-leading laboratory method in determining thyroid stimulating hormone (TSH) levels in blood.

This study, which was supported by the Company’s marketing partner, SEKISUI Diagnostics, provides further validation behind years of in-the-field evidence demonstrating the accuracy and reliability of FastPack compared to laboratory tests for the same application, but while also providing patients and providers the speed and convenience of a point-of-care context.

“The FastPack technology has successfully been utilized for over two decades, and up-to-date real-world clinical evidence is an important pillar in our understanding of its accuracy and utility in the market. This study, which was conducted in a cohort of 100 subjects in Foggia, Italy, corroborates what endocrinologists, diabetologists, and general and internal medicine clinicians have experienced for many years – that FastPack IP provides an easy-to-use, rapid, reproducible – and highly accurate – test for TSH levels, which is essential for prescribing and assessing treatments,” commented Michael Poirier, Qualigen’s Chief Executive Officer.

The Diagnostics study, titled “Comparison between an Emerging Point-of-Care Tool for TSH Evaluation and a Centralized Laboratory-Based Method in a Cohort of Patients from Southern Italy”¹ demonstrated a strong correlation between the FastPack TSH results and those taken from laboratory analysis. Further, the subjects who participated in the study were accustomed to undergoing TSH testing 3-5 times per year and expressed complaints about the time required to receive laboratory results. All patients who participated in the study noted the advantage of the shorter time-to-result that FastPack provides.

The study protocol required investigators to take serum from 72 patients and 28 control subjects who provided a single blood withdrawal at a central laboratory to assess TSH values by means of FastPack compared to the ACCESS2 Beckman Coulter instrument. Investigators were able to readily obtain results much faster by FastPack (within about 15 minutes) as opposed to the 2-day response time required by Beckman ACCESS2.

“We have spent many years collaborating with Qualigen and are very pleased to see the real-world clinical performance, value and utility of the FastPack platform demonstrated through this comprehensive scientific study”, said Lee Lipski, Sr. VP IVD Business Unit, SEKISUI Diagnostics.

Sales of Qualigen's FDA-approved FastPack System diagnostic instruments and test kits have exceeded $100 million since inception and have been used successfully in diagnostics for over 20 years. FastPack provides rapid and accurate immunoassay tests for prostate cancer, men’s health, hormone function, PSA, testosterone, thyroid disorders, pregnancy, and Vitamin D status.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, as well as maintaining and expanding its core FDA-approved FastPack^® System, which has been used successfully in diagnostics for 20 years. Qualigen’s aptamer platform, of which QN-247 is the lead candidate, inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells, thus influencing their proliferation, survival, and metastasis. QN-247 has shown promise in pre-clinical studies for the treatment of acute myeloid leukemia (AML). Qualigen’s RAS-F platform is a family of RAS oncogene protein-protein interaction inhibitor small molecules that is believed to disrupt pathways for cancer genes that cause tumor formation. Such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. The RAS pathway has generated considerable interest due to recent breakthrough developments in the field and the first clinical approval earlier this year for a K-RAS directed drug. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems for the management of prostate cancer and other diseases and health conditions. Qualigen’s management has significant experience in drug and medical device development, manufacturing, marketing, and distribution.

For more information about Qualigen Therapeutics, Inc. please visit www.qualigeninc.com.

Forward-Looking Statements

This news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the Company's prospects and strategy for the development of therapeutic drug candidates. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that the Company will develop any drugs (including QN-247 and RAS-F); that preclinical or clinical development of the Company's drugs (including QN-247 and RAS-F, and deprioritized infectious-disease programs such as QN-165) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs will receive required regulatory approvals (including Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's currently owned and inlicensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (including QN-247 and RAS-F, and any repositioning of QN-165); or that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business can be found in the Company's prior filings with the Securities and Exchange Commission, including its most recent Form 10-K, all of which are available at www.sec.gov.

The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor Relations:

For further information: David Kugelman
Atlanta Capital Partners, LLC
(404) 856-9157 or (866) 692-6847 Toll Free - U.S. & Canada
dk@atlcp.com

Tony Schor
Investor Awareness, Inc.
(847) 971-0922
tony@investorawareness.com

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¹ Di Cerbo, A.; Quagliano, N.; Napolitano, A.; Pezzuto, F.; Iannitti, T.; Di Cerbo, A. Comparison between an Emerging Point-of-Care Tool for TSH Evaluation and a Centralized Laboratory-Based Method in a Cohort of Patients from Southern Italy. Diagnostics 2021, 11, 1590. https://doi.org/10.3390/diagnostics11091590.