rotigotine transdermal patch / BioNxt - LARVOL DELTA

BioNxt Receives Approval for European Clinical Study of Transdermal Rotigotine Patch for Parkinson’s Disease (BioSpace) - "BioNxt Solutions Inc...is pleased to report that it has received government approval for to proceed with its comparative drug absorption study for the Company's transdermal ('TDS') Rotigotine patch for the treatment of Parkinson's disease. The study is expected to commence in four to six weeks....The human study will be carried out in Europe in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches. The Company has completed the manufacture of all transdermal clinical samples to be used in the study based on the TDS platform technology developed by BioNxt's wholly owned German subsidiary."

New trial • CNS Disorders • Parkinson's Disease

BioNxt Signs Clinical Study Agreement and Commences Manufacture of Clinical Samples for Study of Transdermal Rotigotine Patch for Parkinson’s Disease (BioSpace) - "BioNxt Solutions Inc...is pleased to report that it has executed an agreement to carry out its comparative drug absorption study for the Company's transdermal ('TDS') Rotigotine patch for the treatment of Parkinson's disease. BioNxt has also commenced the manufacture of clinical samples for use in the study which is planned for early Q2 2023....The Company has also commenced the manufacture of transdermal clinical samples based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ('Vektor')."

Commercial • Licensing / partnership • CNS Disorders • Parkinson's Disease

BioNxt Reports Update on Commercialization of Rotigotine Patch for Treatment of Parkinson's Disease (BioSpace) - "BioNxt Solutions Inc...is pleased to report an update on its commercialization plan for its transdermal Rotigotine patch for the treatment of Parkinson's disease...the Company is preparing for a human clinical pilot study in Q2 2023. The comparative study is designed as a randomized, crossover, two-period, single dose pilot study to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt's new formulation compared to the name brand product....In parallel to its clinical study, BioNxt is planning the development of commercial manufacturing capabilities at its German drug development facility....The Company expects to make further announcements regarding its commercialization capabilities over the coming months."

Commercial • New trial • CNS Disorders • Parkinson's Disease

XPhyto Reports Excellent Rotigotine In-Vitro/Ex-Vivo Results for Parkinson’s Disease Treatment (Yahoo Finance) - "XPhyto Therapeutics...is pleased to report the results of its Rotigotine transdermal ('TDS') patch human skin cadaver study and dissolution data. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ('Vektor')....We are confident that our Rotigotine patch is fully optimized and ready for further human clinical evaluation. This is a major milestone in the pathway to product commercialization."

Preclinical • CNS Disorders • Parkinson's Disease

XPhyto Completes Rotigotine Transdermal Patch Optimization and Comparative Skin Absorption Study (Yahoo Finance) - “XPhyto Therapeutics Corp…is pleased to provide a product development report on its Rotigotine transdermal (‘TDS’) patch. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH (‘Vektor’)….After several rounds of skin permeation studies using mouse and human cadaver skin samples to compare Rotigotine absorption between XPhyto's formulas and the name brand product, XPhyto is pleased to announce that its Rotigotine TDS formula is complete. Upon the recent formula completion, the Company carried out what it anticipates to be the final comparative human skin cadaver study. This study is now complete and analytical results are expected to be finalized and announced within the coming days.”

Clinical • Preclinical • CNS Disorders • Parkinson's Disease

XPhyto Reports Product Developments on Platform-Based Rotigotine Transdermal Patch for Parkinson’s Disease (Yahoo News) - "XPhyto Therapeutics Corp...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....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 is also planning to scale-up manufacturing capacity to meet the required sample volume for the pivotal study planned for Q4 2022."

Commercial • New trial • Preclinical • CNS Disorders • Parkinson's Disease

XPhyto Reports Market and Product Developments on Platform-based Rotigotine Transdermal Patch for Parkinson's Disease (Yahoo News) - "XPhyto Therapeutics Corp...is pleased to provide a market and product development report on its Rotigotine transdermal ('TDS') patch....As an interim step to evaluate optimization opportunities prior to the pivotal study, the Company has completed a human cadaver skin permeation study at Vektor's EU GMP laboratory and manufacturing facility in Baden-Württemberg, Germany, to compare Rotigotine absorption between two additional derivative formulas and the name brand product. Analytical results of this study are expected to be finalized and announced in the coming weeks."

Preclinical • CNS Disorders • Parkinson's Disease