Jan 18, 2021 in Press Releases
XPhyto Announces Business Strategy And Milestones For 2021
- Commercialization of rapid COVID-19 PCR test
- Clinical validation of transdermal and sublingual drug formulations
- Psychedelic API production, drug formulation and clinical integration
Vancouver, Canada (January 18, 2021) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to announce its business strategy and milestones for 2021. The Company is on the cusp of transformational change as product development programs advance from the laboratory to the clinic. As a bioscience accelerator at the leading-edge of the life science industry, XPhyto will target growth through commercialization of existing products and focused investment in impact driven innovation with the potential for extreme value creation.
The Company will continue to leverage its scientific expertise and operations in Europe and North America for product development and optimization while it plans to add significant commercial experience in the fields of manufacturing, distribution, marketing and sales. Following a successful business year 2020, XPhyto is well positioned to execute on important core milestones in all business divisions, which include the commercialization of infectious disease diagnostics, the clinical validation of transdermal and sublingual drug formulations and continued investment and development in psychedelic medicine.
XPhyto’s lead diagnostic product is an accurate, rapid and highly portable PCR diagnostic test system which is secured under an exclusive global commercialization agreement from its German development partner, 3a-diagnostics GmbH (“3a”). PCR testing has emerged as the only internationally recognized standard for COVID-19 testing, which is expected to play a critical role in expediting the revitalization of many industries, particularly domestic and international travel. Successful validation of the PCR system was achieved in Q4 2020 and the Company is confident that European commercial (CE-IVD) approval will be achieved in Q1 2021. XPhyto is in discussions to secure manufacturing and distribution partners in Europe and the Middle East in anticipation of pending commercial approval and product launch in Q1 2021.
In addition to COVID-19 products, XPhyto and its partner 3a, are developing and commercializing a portfolio of low-cost oral biosensors. The Company’s lead biosensor product is an oral health screening test for the detection of peri-implantitis. There is a significant clinical need for the early detection of infection associated with dental implants prior to the onset of irreversible tissue and bone damage. The company is targeting late 2021 for European commercial approval and product launch for several biosensor screening tests.
Drug Formulations and Delivery
XPhyto’s drug formulation business is focused on neurological indications with significant market demand and the potential for meaningful patient impact. In 2020, XPhyto’s German subsidiary, Vektor Pharma TF GmbH (“Vektor”), a leader in the development of transdermal and sublingual drug formulations reported significant advancements in four therapeutic development programs. Vektor also successfully developed a sublingual drug formulation on contract for a major generic drug manufacturer and distributor.
In 2021, the Company plans to complete human pilot studies on its four lead therapeutic products: 1) Rotigotine transdermal patch for Parkinson’s disease; 2) CBD oral/sublingual strip for treatment resistant Epilepsy; 3) THC oral/sublingual strip for anorexia/nausea; and 4) CBD:THC (1:1) oral/sublingual strip for Multiple Sclerosis associated spasticity. The Company is currently in ongoing discussions with multiple potential commercial partners, licensors and distributors and will be reviewing monetization opportunities on a continued basis.
Psychedelic compounds are a highly promising new class of active pharmaceutical ingredient (“API”) with strong potential for the treatment of mental health related medical conditions such as depression, anxiety, addiction, and trauma-related stress disorder. Psychedelics could provide a major improvement over currently available therapeutics for a global market with unmet medical need. XPhyto has entered into two psychedelic agreements: first, for the development of industrial scale biotechnology processes for the production of psilocybin, and second, for research and development related to multiple psychedelic compounds, including psilocybin, mescaline, LSD, MDMA, DMT, among others.
In 2021, XPhyto will continue to advance and expand its programs focused on the industrial scale production of psychedelic API, in addition to launching new programs for the development of psychedelic drug formulations, particularly sublingual and transdermal therapeutics, as well as the integration of these therapeutic products into established clinical care programs for mental health related indications.
“2020 was a very productive year for XPhyto. We made significant progress in all areas of our business,” said Hugh Rogers, CEO & Director of XPhyto. “We have ambitious milestones for 2021 with multiple product launches on the horizon, multiple clinical drug programs underway, and an aggressive commitment to psychedelic medicine. I am extremely confident that our team can execute on the Company’s business plan for 2021.”
The Company will provide more detailed plans for each of its diagnostics, drug formulation, and psychedelic businesses in the coming weeks as well as specific updates as they arise. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic.