VANCOUVER, BC, AND UTTENWEILER, GERMANY / ACCESSWIRE / May 9, 2022 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) ("XPhyto" or the "Company") is pleased to provide a product development report on its Rotigotine transdermal ("TDS") patch, including results of its recent human cadaver skin permeation study, first announced April 4, 2022. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor").
On May 13, 2021, XPhyto announced successful completion of a European-based human bioavailability study for its Rotigotine TDS product. The comparative study was carried out over an approximately two-week period as an open label, randomized, crossover, two-period, two-sequence, single dose pilot study to assess the relative bioavailability of its product compared to the name brand product.
As the Company advances its Rotigotine TDS product towards commercialization, Vektor is currently focused on formula optimization, a process which includes the recently completed human cadaver skin permeation study. This study was carried out at Vektor's EU GMP laboratory and manufacturing facility in Baden-Württemberg, Germany, to compare Rotigotine absorption between two potential drug formulations and the name brand product. Results of the study were positive with both new formulas demonstrating absorption within the generic drug formulation target range (+/-20%) in all three cadaver skin samples.
The Company will continue formula optimization work with an emphasis on the manufacturing and production processes. The Company plans to reproduce the human cadaver skin permeation study prior to finalizing the formula and manufacturing process. The Company is also planning to scale-up manufacturing capacity to meet the required sample volume for the pivotal study planned for Q4 2022. Pending positive results in the pivotal study the Company will advance the product to an application for regulatory approval, starting in the EU.
XPhyto's Rotigotine transdermal product is a single product based on Vektor's platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programs. According to Research and Markets, the global transdermal skin patch market had a value of nearly US$6.5 billion in 2020 while Kuick Research, Pharmaceutical and Healthcare, estimate the market will reach approximately US$20 billion by 2028.
Vektor 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 sub-lingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global drug delivery market was valued at US$1,476 billion in 2021 and is expected to grow to US$2,047 billion by 2030.
Executive management of XPhyto's drug formulation business is led by Prof. Dr. Beckert, managing director of Vektor Pharma TF GmbH.
About XPhyto Therapeutics Corp.
XPhyto Therapeutics Corp. is a diversified bioscience accelerator focused on next-generation drug formulation, diagnostic, and new active pharmaceutical ingredient investment opportunities, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and manufacture, standardization, and evaluation of psychedelic compounds for the treatment of neurological conditions. 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.
XPhyto Therapeutics Corp.
Hugh Rogers, CEO and Director
E: [email protected]
Forward looking statements
This news release includes statements containing forward-looking information within the meaning of applicable Canadian securities law ("forward-looking statements"). Forward-looking statements are frequently characterized by words such as "develop", "plan", "continue", "expect", "project", "intend", "believe", "anticipate", "estimate", "potential", "propose" and other similar words, or statements that certain events or conditions "may" or "will" occur, and in this release include the statement regarding the Company's goal of building a successful diagnostic, drug delivery, and medical cannabis company. Forward-looking statements are only predictions based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements, including: that the Company may not succeed in developing a commercial product; that the sale of products may not be a viable business; that the Company may be unable to scale its business; product liability risks; product regulatory risk; general economic conditions; adverse industry events; future legislative and regulatory developments; inability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favourable terms; currency risks; competition; international risks; and other risks beyond the Company's control. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this news release.
SOURCE: XPhyto Therapeutics Corp.