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 Announces Strategic Partnership to Evaluate Kenya BioHub Initiative8.7.2026 15:00:00 CEST | Press release
Company to conduct feasibility assessment for integrated land restoration and renewable energy initiative as part of its strategy to expand its international climate project development pipeline. CALGARY, AB / ACCESS Newswire / July 8, 2026 / Karbon-X Corp. (OTCQB:KARX) ("Karbon-X" or the "Company"), a vertically integrated climate solutions company delivering end-to-end services across global carbon markets and climate infrastructure, today announced a strategic partnership with REGID International ("REGID") to jointly evaluate the Kenya BioHub Initiative, an integrated climate infrastructure program designed to restore degraded land, produce sustainable biomass, and support industrial decarbonization in Kenya. The partnership reflects Karbon-X's disciplined approach to identifying, evaluating, and selectively advancing climate infrastructure opportunities with long-term development potential as part of its strategy to expand its international project development pipeline. The Kenya B
Frame Security Launches KnowBetter as AI Reshapes Social Engineering8.7.2026 14:00:00 CEST | Press release
AI Is Rewriting the Social Engineering Playbook. Security Awareness Training Hasn't Caught Up. Organizations must KnowBetter. NEW YORK CITY, NY / ACCESS Newswire / July 8, 2026 / Security teams have spent two decades training employees to spot a familiar set of red flags: a suspicious link, a misspelled domain, an urgent request for a wire transfer. That approach is now colliding with an attacker toolkit that has changed faster than most awareness programs have. Generative AI has made it possible to clone a voice from a few seconds of audio, generate a passable deepfake video in minutes, and write a phishing email tailored to a specific employee's role, manager, and recent LinkedIn activity. Vishing calls, smishing texts, and video-based impersonation are now standard components of enterprise social engineering campaigns, not edge cases. "Most organizations are still training people to recognize threats from five years ago," said Tal Shlomo, co-founder and CEO of Frame Security, a huma
GoodData.AI Brings Governed Agentic Analytics to Regulated Enterprises Across DACH8.7.2026 13:05:00 CEST | Press release
GoodData.AI lets regulated enterprises in Germany, Austria, and Switzerland build and govern AI agents that support business processes, while maintaining full control over where AI runs and what data it can access. SAN FRANCISCO, CA / ACCESS Newswire / July 8, 2026 / GoodData.AI, an open agentic analytics platform with nearly two decades of analytics experience, today announced an expanded investment in the DACH region, bringing governed agentic analytics to regulated enterprises across Germany, Austria, and Switzerland. Many regulated enterprises have held off on production AI because outputs can't be traced back to approved business logic. GoodData.AI's platform addresses that directly: agents stay on a process over time, drafting and updating reports, analyses, and recommendations as new data comes in, while every output stays grounded in logic the company has already approved and can show an auditor on request. The EU AI Act has introduced some of the most comprehensive AI governan
Polaris Announces Execution of Mixed Investment Agreement for the Three Mexico Projects7.7.2026 13:50:00 CEST | Press release
TORONTO, ON / ACCESS Newswire / July 7, 2026 / Polaris Renewable Energy Inc. (TSX:PIF) ("Polaris" or the "Company") is pleased to announce that, further to its press release dated June 8, 2026, it has reached another important milestone in the development of its three renewable energy projects selected under Mexico's Comisión Federal de Electricidad ("CFE") Mixed Development Program (the "Mixed Program"). On July 3, 2026, Polaris, through its Mexican project structure, executed the Mixed Investment Agreement (Contrato de Inversión Mixta or "CIM") with the fiduciary trustee, Banca Mifel, S.A., Institucion de Banca Multiple, Grupo Financiero Mifel, acting on behalf of CFE. The CIM establishes the contractual 30-year framework governing the joint participation of Polaris and CFE in the development, financing, construction, ownership and operation of the three selected projects, including the applicable governance, economic and corporate arrangements. The CIM includes the key information a
Oxford University Press Comes to Simply Piano7.7.2026 10:00:00 CEST | Press release
Content from OUP's acclaimed piano method is now available to millions of Simply Piano learners worldwide NEW YORK, NY / ACCESS Newswire / July 7, 2026 / Simply, the leading digital platform for creative hobbies, today announced an agreement to bring content from Oxford University Press' (OUP) piano method to Simply Piano. This expands Simply Piano's offering and marks a step forward in its mission to make the pursuit of creative hobbies simple and fun for all. Simply Piano users around the world will gain access to an expanded library of high-quality, curated sheet music spanning OUP's works including Piano Time and Tunes for Ten Fingers, all within the app's interactive learning environment. The integration expands Simply Piano's sheet music library across genres, complementing its step-by-step courses and real-time feedback tools. "Access to songs people love is one of the strongest drivers of learning," said Yuval Kaminka, CEO & co-founder of Simply. "Working with OUP allows us to
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