BioNxt Solutions Inc.
13.3.2024 08:06:55 CET | ACCESS Newswire | Press release
VANCOUVER, BC / ACCESSWIRE / March 13, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to report that the comparative pharmacokinetic ("PK") study for its oral dissolvable film ("ODF") based proprietary Cladribine product for the treatment of Multiple Sclerosis ("MS") has been completed and results received by the Company. The animal PK study results are highly promising and demonstrated comparable rapid absorption and systemic exposure between the Company's ODF product and the name-brand reference drug in all samples.
"These results are a significant milestone for BioNxt. We have demonstrated that our ODF platform is an effective drug delivery system for cytostatic drugs via transmucosal absorption," said Hugh Rogers, CEO of BioNxt. "With our recently obtained toxicology data, the PK results allow us to strengthen the Company's Cladribine ODF patent position and proceed immediately to a PK study in humans. These exciting results validate the potential for BioNxt to immediately expand into additional ODF drug formulations for similar, high-value and highly toxic drugs."
BioNxt is developing a 100% owned and proprietary hybrid-generic ODF Cladribine dosage form, directed at the MS market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us.
The comparative PK study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines using animal models and a single administration of either sublingual (ODF) or oral (tablet) Cladribine. Blood testing and analysis was carried out pre-dose and at up to six time points after administration using blood aliquots. The animal PK study results closely follows the unanimously successful results of the ODF Cladribine animal toxicity study, announced February 7, 2024: positive results were observed in all study participants with no adverse clinical abnormalities or indications of toxicity observed in the study after consecutive days of dosing.
BioNxt has accelerated its Cladribine ODF program in a priority manner with GMP product development and batch production planned for Q1 and Q2 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for Q2 2024.
The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.
BioNxt's wholly owned subsidiary is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sublingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global pharmaceutical drug delivery market size was valued at USD 1,525 billion in 2022 and expected to surpass approximately USD 2,047 billion by 2030.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and new active pharmaceutical production and evaluation, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization and clinical evaluation of emerging active pharmaceutical ingredients for neurological applications. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.
BioNxt Solutions Inc.
Hugh Rogers, CEO and Director
Email: info@bionxt.com
Phone: +1 780-818-6422
Cautionary Statement Regarding "Forward-Looking" Information
Some of the statements contained in this news release are forward-looking statements and information within the meaning of applicable securities laws. Forward-looking statements and information can be identified by the use of words such as "expects", "intends", "is expected", "potential", "suggests" or variations of such words or phrases, or statements that certain actions, events or results "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements and information are not historical facts and are subject to a number of risks and uncertainties beyond the Company's control. Actual results and developments are likely to differ, and may differ materially, from those expressed or implied by the forward-looking statements contained in this news release. Accordingly, readers should not place undue reliance on forward-looking statements. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements, except as may be required by law.
SOURCE: BioNxt Solutions Inc.
View the original press release on accesswire.com
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
Karbon-X and Evertrak Sign Letter of Intent to Advance Infrastructure-Linked Plastic Waste Reduction Credit Initiative19.5.2026 19:45:00 CEST | Press release
Proposed initiative would evaluate the potential generation of Verra-aligned Plastic Waste Reduction Credits for approximately 200,000 railroad ties made from recycled plastic currently installed across railroad infrastructure in North America. CALGARY, AB / ACCESS Newswire / May 19, 2026 / Karbon-X Corp. (OTCQB:KARX) ("Karbon-X" or the "Company"), a vertically integrated climate solutions company operating across compliance and voluntary environmental markets, today announced the signing of a Letter of Intent with Evertrak LLC ("Evertrak"), the leading manufacturer of Glass Fiber Reinforced Composite (GFRC) railroad ties made from recycled plastic, to explore an infrastructure-linked Plastic Waste Reduction Credit ("PWRC") initiative under Verra's Plastic Waste Reduction (PWR) Standard. Across North America, 20 million railroad ties made from wood are replaced annually. Approximately 4-6 million of those ties are less than 12 years old. Safe, resilient, and efficient railroad infrastr
AP Technologies Acquires Blueacre Technology, Adding Nitinol and Precision Laser Processing to Its Catheter Platform19.5.2026 16:00:00 CEST | Press release
Acquisition extends AP Technologies' vertically integrated catheter platform into nitinol and precision laser processing. Dundalk, Ireland joins the company's network of Centers of Excellence as its first European operation. SINGAPORE AND DUNDALK, IRELAND / ACCESS Newswire / May 19, 2026 / AP Technologies, a vertically integrated contract manufacturer of catheters and medical tubing, today announced the acquisition of Blueacre Technology, a Dundalk, Ireland specialist in laser micromachining and nitinol processing for the medical device industry. The acquisition establishes AP Technologies' first European operation in Ireland's medtech corridor, and extends its catheter platform into the laser-processed metallic components used in next-generation minimally invasive devices. Terms were not disclosed. Blueacre brings nearly two decades of capability in laser micromachining and nitinol processing for the medical device industry, including femtosecond and picosecond laser cutting, laser we
Business Leaders Still Primarily Use AI for Simple Tasks, Study from General Assembly and EZRA Finds19.5.2026 15:00:00 CEST | Press release
Those who have received leadership-specific AI training more likely to use AI more often and more strategically NEW YORK CITY, NY / ACCESS Newswire / May 19, 2026 / A new survey of more than 500 U.S. and U.K. business leaders found that while they are increasingly confident in their own AI skills, the most common use cases of the technology at the leadership level remain simple tasks like searching for information (69%), summarizing documents (68%) and drafting emails (58%). Strategic applications such as scenario planning (27%), organizational design (27%) and financial modeling (28%) lag far behind. The research was conducted by General Assembly, a global leader in practical AI skills training, in collaboration with EZRA, a leading global coaching and learning provider, both LHH brands. The study also surfaces a sharp divide between leadership levels. Vice presidents consistently fall behind director-level colleagues across nearly every measure of AI adoption and competence, emerging
Europe's Hospital Cybersecurity Hot Zones and Top Cyber Vendors as EHR and EPR Attacks Shift From Data Theft to Care Disruption19.5.2026 14:50:00 CEST | Press release
Recent European hospital incidents, NIS2 accountability, EPR exposure, supplier concentration, and 72-hour downtime weakness are pushing buyers toward clinical-continuity cybersecurity ahead of HIMSS26 Europe COPENHAGEN, DK / ACCESS Newswire / May 19, 2026 / Black Book Research today issued a new European hospital cybersecurity advisory identifying the countries, attack surfaces, vendor categories, and evaluation standards now shaping hospital cybersecurity buying decisions across Europe. The advisory builds on Black Book's Pre-HIMSS26 Europe Copenhagen Cybersecurity Demand Pulse Survey of 284 self-identified European hospital, health system, HIT, clinical-digital, cybersecurity, procurement, risk, and executive respondents seeking cybersecurity options around HIMSS26 Europe in Copenhagen. Black Book reports that European hospital cybersecurity has moved beyond breach response. The 2026 priority is now clinical availability: protecting EHRs, EPRs, identity systems, lab platforms, pharm
AI Trading Bots Revolutionise Stock, Gold, and Forex Trading: Funds Coin Leads the Move with Guaranteed Profit Option Strategy19.5.2026 14:00:00 CEST | Press release
DENVER, CO / ACCESS Newswire / May 19, 2026 / Forex has always been the world's largest digital financial market in 2026. Now it has become entirely a 24-hour, data-saturated environment. According to the Bank for International Settlements, global OTC foreign exchange turnover reached $9.6 trillion per day in April 2025. This means the foreign exchange turnover was up 28% from 2022. This is a figure that underscores just how deeply connected forex is to global liquidity, risk management, and capital flows. Inside that volume, the competition has intensified dramatically. In 2026, retail traders are no longer competing mainly against other individuals; they are competing against automated systems, and AI-assisted execution engines like Funds Coin. The platform operates across stocks, forex, and financial markets simultaneously. Manual trading, in this environment, is not just inefficient. It is structurally outpaced. Why AI Bots Are Taking Over Forex The following table is provided for
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom