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
Chervon Names Devin Murray Director of Sales - Northern Division19.10.2026 15:00:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / October 19, 2026 / Devin Murray joins Chervon as Director of Sales - Northern Division, effective October 19, 2026, reporting to Thomas Kentouris, Vice President of Field Sales. Murray joins Chervon after completing a six-year fast track career in TTI sales and sales management. Most recently, he was a Key End User Account Manager for Milwaukee charged with growing the pro tool business with large end users. Murray's exceptional recruiting skills and leadership skills enabled him to build, manage and inspire highly effective sales teams at the store level. His account management prowess resulted in outstanding sales results and strong partnerships with multiple national accounts. "Early in his impressive career, Devin was identified as a high potential future superstar executive," said Thomas Kentouris. "His large end user pro tool experience is exactly what we need to help build our pro tool leadership position. His inspiring leadership skills combin
Chervon Names Krystle Adams Director of Sales Recruiting19.10.2026 15:00:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / October 19, 2026 / Krystle Adams joins Chervon as Director of Sales Recruiting, effective October 19, 2026, reporting to Matt DeFeo, SVP of Sales, Training and Recruiting. Over the past 9+ years, Adams has advanced through a series of increasingly responsible sales and recruiting positions at TTI. Earlier in her impressive career, Krystle distinguished herself as an outstanding sales representative and sales manager delivering consistently strong results. Most recently, she was a National Recruiting Operations Manager responsible for leading, coordinating, and implementing recruiting efforts across campuses nationwide. Krystle has demonstrated exceptional skills in developing and leading campus and field sales recruiting efforts. She also designed and executed a thriving national college internship program. "I feel incredibly fortunate to now have Krystle Adams in place to launch Chervon campus recruiting," said Matt DeFeo, SVP of Sales, Training and
Chervon Names Terry Lucero Director of National Accounts - Industrial19.10.2026 15:00:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / October 19, 2026 / Terry Lucero joins Chervon as Director of National Accounts - Industrial, effective October 19, 2026, reporting to Jeff Campbell, Senior Vice President of Industrial Commercial Sales. Lucero brings 25+ years of extensive experience in building professional tool businesses at national accounts, regional accounts, at the store level and at the end user level. Lucero started his career at Dewalt where he advanced through a series of sales, sales management and end user marketing positions over 5 years driving professional tool growth. Lucero went on to WW Grainger where he progressed through a series of business development and sales management positions. He was also a sales manager of professional equipment at United Rentals. Most recently, Lucero served as a director of sales at APEX Tool Group for the Americas. "Terry's impressive pro tool experience in industrial distribution, national account management and end user marketing make
Tenstorrent Announces a $1.5B Series E at a $6.2B Valuation19.10.2026 14:00:00 CEST | Press release
SANTA CLARA, CA / ACCESS Newswire / October 19, 2026 / Tenstorrent, the AI computing company, has closed $1.5B in Series E funding at a $6.2B post-money valuation. The round was led by Trace Capital and Innovation X, with participation from new and existing investors including Agostinelli Group, ARK Invest, Brett Barna, Cadence Ventures, Eclipse, Fidelity Management & Research Company, Maverick Silicon, Morgan Stanley, Protagonist, Sandisk, T. Rowe Price*, Tether Investments, Troluce Capital, Virtu Financial, and XTX Markets. Tenstorrent will use the capital to deploy Galaxy servers at scale, continuing to serve open-weight models across LLMs and video generation, and advance the AI and CPU IP it licenses to customers designing their own silicon. Tenstorrent sells AI compute at every level of the stack - from a single card or workstation to racks, superclusters, and custom IP. With an open-source software stack, developers can run frontier models locally and enterprises can deploy mode
OxyDew Analyzer: One Compact Instrument, Two Critical Gas Measurements19.10.2026 08:00:00 CEST | Press release
NAVAN, IE / ACCESS Newswire / October 19, 2026 / DwyerOmega introduces the new Ntron OxyDew Analyzer, a fully integrated solution that combines oxygen and moisture dew-point measurement in a single, compact wall-mountable analyzer. The result: fewer instruments to install, wire, and maintain, without sacrificing the accuracy and reliability that critical gas quality monitoring demands. By uniting two proven sensing technologies in one instrument, OxyDew cuts equipment costs, simplifies installation, and reduces ongoing maintenance, all without compromising performance. Operators monitor oxygen concentration and dew point simultaneously through a 3-inch color touchscreen, giving them a single point of control instead of two separate systems. OxyDew is available now throughout Europe and Asia Pacific. Integrated Dual Measurement for Reliable Process Monitoring At the heart of OxyDew is the integration of the proven Ntron SenzTx Oxygen Transmitter and Michell Easidew Dew-Point Transmitter
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