AXIM Biotechnologies Files Patent on Fentanyl Neutralizing Antibody Test, Applies for DEA License to Work With Controlled Substance
Diagnostic Healthcare Solutions Company Developing New Test Designed to Measure Neutralizing Antibodies of Deadly Opioid Fentanyl
SAN DIEGO, CA, Jan. 17, 2023 (GLOBE NEWSWIRE) -- via -- . () (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, announced today that it has filed a provisional patent application with the U.S. Patent and Trademark Office on an innovative new test designed to measure the neutralizing antibodies against fentanyl, a synthetic opioid responsible for the world’s leading cause of overdose. Additionally, the Company has filed for a license to handle the controlled substance with the Drug Enforcement Administration (DEA) as required for research.
Fentanyl is a powerful synthetic opioid that is 50 to 100 times stronger than morphine and has a strong addiction profile and associated overdose risk. Prevention of fentanyl addiction and overdose within the current healthcare landscape is difficult. However, new research is being conducted on potential immunotherapies () and vaccines () that prevent fentanyl from breaching blood-brain barrier to preemptively circumvent its overdose effects. ()
Recent research suggests that fentanyl neutralizing antibodies may prevent overdose deaths, but scientists will need to quantitatively measure a patient’s neutralizing antibodies throughout clinical studies and for relapse prevention from boosters, and such a test does not currently exist on the market. As a result and leveraging its experience in diagnostics and working with neutralizing antibodies, AXIM® is developing a rapid point-of-care diagnostic assay that will detect and measure levels of fentanyl neutralizing antibodies. This breakthrough in diagnostic solutions will enable therapeutic and vaccine scientists to expedite transition of their research from lab to clinic using AXIM’s new test given the test’s quick time to result at clinical settings.
AXIM’s ongoing discussions with various academic and research groups on potential collaboration on the new test signal broad enthusiasm among the scientific community for its development and commercialization.
“This test is another example of the broad applications of AXIM’s diagnostic platform,” said John Huemoeller II, CEO of AXIM® Biotechnologies. “We continue to be able to leverage our processes and scientific expertise in developing rapid diagnostic assays of commercial significance. As most know, the fentanyl crisis continues to plague the US as well as many other countries and scientists from a myriad of fields continue to research ways to combat the devastation this lethal drug is causing. The commercial applications of this test are far and wide and represent a massive opportunity for AXIM. Once we receive our DEA license, we plan to begin clinical studies on the assay immediately, with the hopes of commercialization in the second quarter of 2023.”
Fentanyl addiction and overdose has skyrocketed in recent years amid the widely covered “opioid crisis.” According to the CDC, over 150 people die every day in the US from overdoses related to synthetic opioids like fentanyl and the drug is the primary driver of overdose deaths in the United States. () For this reason, the US and other government and regulatory bodies are incentivizing organizations through grants and licenses to conduct research on potential therapeutics or vaccines that may prevent overdose or addiction. AXIM plans to market its newly developed test to these research institutions as a leading way to measure neutralizing antibodies in clinical trial patients.
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. Additionally, it owns IP and has conducted research on SARS-CoV-2 (COVID-19) rapid neutralizing antibody tests to detect levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells, as well as for oncological indications. For more information, please visit .
Forward-Looking Statements
The statements made by Axim Biotechnologies Inc., in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Axim’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Axim Biotechnologies, Inc. Actual results could differ materially from those projected due to there being no assurance that our diagnostic candidate will ever be approved for use by the U.S. FDA or any equivalent foreign regulatory agency. Further, Axim’s eye care diagnostic products that are FDA cleared may not be manufactured in large enough quantities or that third parties with established eye care physicians will enter into agreements or purchase from the Company, and even if the Company’s diagnostic candidates are successful, they may generate only limited revenue and profits for the Company. Various other factors are detailed from time to time in Axim’s SEC reports and filings, including our Annual Report on Form 10-K filed on April 15, 2022, and other reports we file with the SEC, which are available at . Axim Biotechnologies, Inc., undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
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