Posted by AGORACOM
at 8:35 AM on Thursday, March 18th, 2021
CE Mark received for in vitro diagnostic (IVD) test for the detection of SARS-CoV-2
Rapid results with ease of use – single 20-minute PCR cycle plus 5-minute detection process
High sensitivity – 104.73 c/PCR limit of detection with 95% confidence interval
High specificity – zero cross-reactivity on 19x respiratory infectious disease panel
High robustness – no impact on results from minor changes in process parameters
100% repeatability and laboratory precision observed
Sales launch in Europe planned for April 2021
XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce the European approval of its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”). Covid-ID Lab is now registered within the European Union as a commercial in vitro diagnostic (CE-IVD) test.
“Our test is one of the fastest PCR-based COVID-19 tests currently approved. With a sample collection to result time of 25 minutes, Covid-ID Lab combines the speed of a rapid screening test with the accuracy of a PCR diagnostic,” said Hugh Rogers, CEO and Director of XPhyto. “Covid-ID Lab is designed for point-of-care testing, particularly in satellite and small-scale labs, such as transportation hubs, borders, care facilities, schools, pharmacies, and hospitality settings.”
Covid-ID Lab is a multiplex viral RNA probe kit based on the reverse transcriptase-polymerase chain reaction (RT-PCR) method. For assay performance, Covid-ID Lab requires only a single 20-minute PCR thermal cycle without prior RNA extraction as part of the sample preparation. Many widely available standard PCR instruments are suitable to run the test. Results are collected after the PCR cycle via easy-to-read optical indicator strips on a simple fluidics platform. The elimination of RNA extraction for sample preparation reduces the risk of cross-contamination and minimizes the need for lab materials and trained personnel. The rapid results, minimal laboratory equipment, and ease of use are expected to translate into reduced operating costs, greater convenience and portability.
During validation of the assay, the limit of detection for SARS-CoV-2 RNA was determined to be 104.73 c/PCR within a 95% confidence interval. Specificity of 100% against 19 other pathogens of serious respiratory infections was demonstrated on a respiratory verification panel. Precision was determined through evaluation of variance of the analysis results due to random deviations, a repeatability/intra-assay precision evaluation (same lab, user, equipment, etc.), and a laboratory precision evaluation (different lab, user, equipment, etc.). Robustness was measured by evaluation of the impact of minor changes on process parameters (transport medium, PCR cycler model, ramp rate, template volume, hybridization mixing ratio, etc.). The validation studies were carried out accordingly to ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology and VQ-015 Validation of Methods, European Medicines Agency. The quality management system was in accordance with EN ISO 13485: 2016 and EN ISO 9001: 2015.
Posted by AGORACOM
at 8:05 AM on Thursday, March 4th, 2021
Rebranding Reflects XPhyto’s Commitment To Operational Achievement
Product Development Advance From The Lab To The Clinic
Cusp Of Two Major Commercial Milestones Related To Our Rapid Point-Of-Care COVID-19 PCR Test System
A Bioscience Accelerator At The Leading-Edge Of The Life Science Industry
XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”), is pleased to announce that the Company has completed a corporate rebranding and launched a new website which can be viewed at www.xphyto.com.
The rebranding decision reflects the Company’s commitment to operational achievement in 2021 as a number of product development programs advance from the laboratory to the clinic. As a bioscience accelerator at the leading-edge of the life science industry, XPhyto is targeting value creation through commercialization of its development pipeline and focused investment in impact driven innovation.
“The Company is excited to introduce a fresh look at such a pivotal point in our business growth,” said Hugh Rogers, CEO & Director of XPhyto. “With all technical requirements fulfilled, we are on the cusp of two major commercial milestones related to our rapid point-of-care COVID-19 PCR test system. With expected ISO certification and CE-IVD approval pending, we are excited to enter the next phase of our business with a positive, crisp and energetic new image.”
The Company will provide further information and updates in due course. 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. Further, its COVID-19 related test products are not yet approved and are still subject to risks associated with the regulatory approval process.
Posted by AGORACOM
at 8:05 AM on Wednesday, February 24th, 2021
Placed First Order for its Rapid Point-Of-Care COVID-19 Test System
9600 Individual Tests Ordered
Mid-March Delivery
Additional Pandemic-Focused Biosensors in Development
XPhyto Therapeutics. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company“), is pleased to announce that it has placed the first order for its rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”) from its exclusive diagnostic development partner, 3a-diagnostics GmbH (“3a”).
The first order of Covid-ID Lab is for 9,600 individual tests, which are packaged in 200 kits of 48 tests each. Delivery of the first order is expected by mid-March 2021 and will be primarily used to supply prospective distribution partners and licensees and their respective government regulators with test samples for review and evaluation. The tests will be manufactured in the German state of Baden-Württemberg.
“We are pleased to report that all steps towards the launch of Covid-ID Lab remain on track within an ambitious timeline,” said Hugh Rogers, CEO, and Director of XPhyto. “Our experienced market launch team is working quickly to bring the product to market, as well as to establish licensing and distribution partnerships. We are confident that Covid-ID Lab, as a 25-minute PCR test with minimal technical and personnel requirements, will be a stand-out product in the COVID-19 test market.”
Covid-ID Lab was designed to be a rapid, accurate, and robust COVID-19 test system with reduced operating costs and increased convenience and portability. XPhyto expects 3a to receive ISO 13485 medical device manufacturer approval by the end of February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March. Initial commercial manufacturing is planned for Germany, with additional capacity in other jurisdictions to follow. The sales launch in Europe is targeted for April 2021. XPhyto is currently in discussions with potential distribution and wholesale partners in Europe and the Middle East.
XPhyto and 3a are also developing a portfolio of oral biosensor screening tests for detection of bacterial and viral infectious diseases, including influenza A, group A strep, stomatitis, periimplantitis, and periodontitis. Additional pandemic-focused biosensors are in development, specifically for H1N1 (swine flu) and H5N1 (avian flu). The Company is planning the commercial launch of its first biosensor product in the second half of 2021.
Posted by AGORACOM
at 8:32 AM on Monday, February 22nd, 2021
Expedited formation of commercial team to launch its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system
Expects medical device manufacturer approval by the end of February
European regulatory approval as a commercial in vitro diagnostic device by early March.
XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) (“XPhyto” or the “Company“), is pleased to announce that the Company has expedited the formation of an experienced commercial team to launch its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”). Covid-ID Lab was developed by XPhyto’s exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”). XPhyto expects 3a to receive ISO 13485 medical device manufacturer approval by the end of February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March.
The market launch team consists of world-class clinical and pharmaceutical executives and service providers who bring the experience and expertise necessary to effectively and rapidly drive the commercialization of Covid-ID Lab. Collectively, the team brings decades of experience in the biotech and pharmaceutical industries, including: executive leadership, business development, regulatory compliance, product launch, international marketing and sales, production, quality assurance, and M&A. In particular, members of the team have led medical diagnostic company growth from inception to over 500 million Euro per year in multinational sales.
“We are extremely fortunate to now have a team with deep expertise in medical diagnostic product commercialization. The team has extensive experience from regulatory approval to international production and sales,” said Hugh Rogers, CEO and Director of XPhyto. “As we near expected regulatory approval, XPhyto’s business is rapidly evolving from innovation to impact. We are working hard to put the Company in the best possible position to execute on our business strategy.”
Posted by AGORACOM
at 8:11 AM on Tuesday, February 16th, 2021
Expects approval as a medical device manufacturer by late February
European regulatory approval as a commercial in vitro diagnostic device by early March.
Covid-ID Lab was designed to be a rapid, accurate and robust test system with reduced operating costs and increased convenience and portability.
XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce all actions and procedures required for XPhyto Therapeutics Corp.’s European regulatory application for the rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system have been completed. 3a-diagnostics GmbH, Xphyto’s exclusive German diagnostics development partner, expects ISO 13485 approval as a medical device manufacturer by late February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March.
“We are very pleased with the team’s swift development progress,” said Hugh Rogers, CEO & Director of XPhyto. “Our goal was to create the fastest and most portable COVID-19 PCR test on the market. We are confident in our prospects for an expedited approval and look forward to commercial launch in short order”
Posted by AGORACOM
at 8:21 AM on Wednesday, February 10th, 2021
Focused on the synthesis of pharmaceutical grade mescaline
Mescaline has shown particular promise for the treatment of addiction and depression.
Xphyto Laboratories Inc., Xphyto Therapeutics Corp.’s wholly owned Alberta subsidiary, has added mescaline production to its psychedelic medicine programs. Further to the Company’s press release dated February 3, 2021, the capacity under contract with Applied Pharmaceutical Innovation will focus on the synthesis of pharmaceutical grade mescaline. Mescaline has been anecdotally recognized as a relatively safe psychedelic drug and has shown particular promise for the treatment of addiction and depression.
“In addition to our European-based psilocybin biotechnology production, the Company has now expanded its portfolio of psychedelic compounds to include mescaline. Our goal is to develop industrial scale production processes for the wholesale market and for incorporation into XPhyto’s thin film drug delivery platforms” commented Hugh Rogers, CEO & Director. “We see a significant market opportunity in the production of pharmaceutical mescaline and the standardization of dosage formulations with precise, predictable and efficient drug delivery for clinical study and therapeutic use”
Mescaline (3,4,5-trimethoxyphenethylamine) is a naturally occurring psychedelic compound found in certain cacti, including peyote, San Pedro, and Peruvian torch, and is most commonly associated with traditional Native American religious rituals and ceremonies. Mescaline is a Schedule I drug in the United States; however, it is legal in certain religious ceremonies registered by the Native American Church and its use is expanding as a supplement to various types of meditation and psychedelic therapy.
In general, psychedelic compounds have emerged as a new class of drugs with the potential to improve the treatment of mental health related medical conditions such as depression, anxiety, addiction, and trauma-related stress disorder. The Company believes that the industrial-scale production of pharmaceutical grade psilocybin and mescaline will provide a strong foundation for its psychedelic medicine programs.
Posted by AGORACOM
at 8:29 AM on Wednesday, February 3rd, 2021
Announces Psychedelic Pharmaceutical Production Agreement
Synthesis of pharmaceutical grade psychedelic compounds
Working toward regulatory approval for the commercial production process
XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”) is pleased to announce that XPhyto Laboratories Inc. (“XPhyto Labs”), its wholly owned Alberta subsidiary, has signed an agreement (the “Agreement”) with Applied Pharmaceutical Innovation (“Applied”) for the synthesis of pharmaceutical grade psychedelic compounds and the parallel development of the standard operating procedures necessary to obtain regulatory approval for the respective commercial production process.
The industrial-scale production of standardized active pharmaceutical ingredients is an important part of XPhyto’s psychedelic pharmaceutical program as the Company anticipates a shortage of large-scale supply of certain approved and standardized pharmaceutical grade psychedelics.
Applied is a not-for-profit institution at the University of Alberta created to support translational drug development for industry and innovators. With an interdisciplinary team of over 30 pharmaceutical scientists, clinicians, regulatory, patent, and market experts, Applied provides industry with access to translational science in a framework that supports commercial success. This includes retention of IP and ownership of work product for the funder, focused and efficient project execution, and regulatory compliant operations.
Posted by AGORACOM
at 7:56 AM on Thursday, January 28th, 2021
Construction of commercial drug manufacturing facility in Germany
Four clinical studies in neurological indications in 2021
Development of oral biosensor and contract development & manufacturing
Psychedelic transdermal and sublingual drug formulation development
VANCOUVER, BC / ACCESSWIRE / January 28, 2021 /XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company“) is pleased to announce its drug formulation and delivery business strategy and milestones for 2021. As a bioscience accelerator at the leading-edge of the life science industry, XPhyto targets growth through commercialization of its product pipeline and focused investment in impact driven innovation with the potential for meaningful value creation.
Further to XPhyto’s press release dated January 18, 2021, the Company’s core milestones for this year include the commercialization of infectious disease diagnostics, the clinical validation of transdermal and sublingual drug formulations and continued investment in psychedelic medicine.
Regarding XPhyto’s drug formulation business, the Company is pleased to set out the strategy and milestones for 2021 of its wholly owned German subsidiary, Vektor Pharma TF GmbH (“Vektor”). Vektor will position itself for commercial manufacturing, pipeline development and drug formulations for critical mental health conditions.
“2021 is expected to be a transformative year for Vektor. We will be building on significant momentum from 2020 as we advance our drug formulation, contract development, and psychedelic business,” said Prof. Dr. Thomas Beckert, managing director of Vektor Pharma TF GmbH. “The addition of scalable in-house manufacturing capability creates the potential for significant growth across virtually all of our development and commercialization programs.”
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 thin film drug formulations, particularly transdermal patches and sub-lingual (oral) strips for the delivery of active pharmaceutical ingredients (“API”) for the treatment of pain and neurological conditions.
Posted by AGORACOM
at 7:41 AM on Monday, January 18th, 2021
Commercialization of rapid COVID-19 PCR test
Clinical validation of transdermal and sublingual drug formulations
Psychedelic API production, drug formulation and clinical integration
XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB: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.
Diagnostics
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.
Psychedelics
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.
Posted by AGORACOM
at 12:37 PM on Thursday, January 7th, 2021
(CSE:XPHY / OTC:XPHYF / FSE:4XT)
Completed Successful SARS-CoV-2 RT-PCR Diagnostic Test Kit Validation
Secured Exclusive Psychedelic Drug Development Agreement
Appointed European Healthcare Executive to Board of Director
Engaged German Partner for Development of Psilocybin API Production
Announced Update on Contract Drug Delivery Program
Announced Update on Oral Thin Film Drug Delivery Program
Provided Update on Parkinson’s Transdermal Patch
Three Xphyto Divisions:
1. Vektor Pharma TF: World-class thin film drug delivery platforms for transdermal and oral dissolvable dosage forms
2. 3a-Diagnostics: Rapid, low-cost screening tests for pandemic and dental health applications
3. Xphyto Laboratories Inc.: Development of industrial production processes for emerging active pharmaceutical ingredients, including psychedelics and cannabinoid isolates
1. Vektor Pharma TF GmbH – Drug Delivery
100% owned XPhyto subsidiary
Global leader in design, testing and manufacture of therapeutic film drug delivery systems
Major pharma clients – past, present and future
Focused and nimble team – rapid turnaround on new opportunities
Versatile platform technology
Transdermal patches (TDS) – slow and steady release
Oral dissolvable film (ODF) sublingual strips – instant bioavailability
EU GMP facilities in Baden-Württemberg, Germany
Holder of numerous German narcotics import and manufacturing licences
XPhyto Drug Development Pipeline – Stage 1 & 2
Platform technology
Scalable product development pipeline
High-growth and new API opportunities
Neurological indications
Generic and hybrid-generic drug formulations
2. 3a-Diagnostics GmbH – Rapid Testing
XPhyto has an exclusive development, technology purchase and licence agreement
Specializing in the development, production, and marketing of low-cost point-of-care screening test systems:
COVID-19 rapid PCR Kit
COVID-19 disposable ultra-rapid test
Oral biosensors for the instant detection of bacterial and viral pathogens
Influenza A, H1N1 (swine flu), H5N1 (avian flu), Strep A, stomatitis, periimplantitis and periodontitis
Biosensor screening platform for high-throughput for identification of new biosensor targets for new biosensor products
Development partially funded by grants from the German Federal Ministry of Education and Research (BMBF)
