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Ottawa Citizen

PharmaTher Unveils KetaVault™: A First-of-Its-Kind Portal to Accelerate Ketamine Research and Commercialization

Article content KetaVault™ to Provide Partners Unprecedented Access to PharmaTher's Extensive Regulatory, Manufacturing, and Clinical Ketamine Data, Aiming to Expedite New Therapies and Market Entry Article content Article content TORONTO, May 14, 2025 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the 'Company' or 'PharmaTher') (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on the research and commercialization of ketamine for unmet medical needs, today announced the launch of KetaVault™. This innovative, world-first portal offers pharmaceutical and biotech companies, academic and clinical researchers, and government agencies to partner with PharmaTher for direct access to its comprehensive proprietary data on ketamine. KetaVault™ is strategically designed to streamline and accelerate clinical trials, regulatory submissions, and commercialization initiatives for ketamine-based therapies. Article content Article content The launch of KetaVault™ is strategically timed with the Company's anticipated FDA approval for its ketamine product, which has an approval goal date of June 4, 2025. This dual milestone underscores PharmaTher's commitment to leading innovation in the ketamine space. KetaVault™ is positioned to be a pivotal catalyst, empowering partners to leverage PharmaTher's deep expertise and data to unlock new therapeutic avenues for ketamine in areas of high unmet medical need and for emergency use applications, potentially revolutionizing treatment paradigms. Article content Fabio Chianelli, Chairman and CEO of PharmaTher, commented: 'PharmaTher is committed to revolutionizing patient care through ketamine. With KetaVault™, PharmaTher isn't just sharing data; we're igniting a new era of collaborative ketamine innovation. This platform is a bold step toward unlocking the full potential of ketamine, empowering our partners with unprecedented access to our years of dedicated work, rich proprietary insights, and collectively accelerating the journey towards novel treatments for patients in critical need. As we near our FDA approval goal date for ketamine, KetaVault™ will serve as a critical tool to expand ketamine's therapeutic reach and solidify PharmaTher's leadership in the market for ketamine, creating significant value for our partners and shareholders.' Article content Article content Expedited Regulatory Pathways: Leverage existing data to potentially streamline investigational new drug applications and emergency use authorizations. De-risked Clinical Development: Inform trial design, safety and efficacy data, and identify promising indications based on robust existing research. Enhanced Commercial Strategy: Gain insights into manufacturing, control, and product development for market readiness. Article content Regulatory Filings: Investigational New Drug (IND) Applications. Comprehensive Drug Information: Investigator's Brochures. Manufacturing Insights: Chemistry, Manufacturing, and Control (CMC) data. Clinical Research & Data: In-depth clinical study protocols and research data for indications including Parkinson's disease. Orphan Drug Designations: Access to information supporting FDA Orphan Drug Approvals for Amyotrophic Lateral Sclerosis, Rett Syndrome, Complex Regional Pain Syndrome, Status Epilepticus, and ischemia/reperfusion injury during solid organ transplantation. Novel Delivery Systems: Product development programs and regulatory filings for PharmaTher's ketamine microneedle patch and subcutaneous wearable pump.