New Brunswick’s rushed flavour ban fails to consider the consequences
Beamsville, ON, June 11, 2021 (GLOBE NEWSWIRE) -- The Canadian Vaping Association (CVA) is deeply saddened by New Brunswick’s decision to ban flavoured vape products. The CVA warned the province that banning flavoured products would be ineffective for youth protection and would cause a spike in smoking rates and black-market products. Unfortunately, regulators largely refused to engage on the issue and rushed to pass the ill-conceived ban.
Not only has New Brunswick failed the adult smokers that rely on flavoured products to remain smoke-free, but it has also failed to consider the economic costs of the policy. Specialty vape shops are small family run businesses, and their survival is dependent on flavoured products. Unlike the products sold in convenience stores, specialty store products rely on flavours to convert smokers. The flavour ban will result in the closure of dozens of small businesses, broken lease agreements and approximately 200 lost jobs. The destruction of these small businesses comes at a time when local economies are especially fragile after months of COVID related shutdowns.
While well intentioned, the flavour ban will do little to protect youth as surveys find that most youth are acquiring vape products through social sourcing and foreign websites. There is also little evidence to suggest that flavour bans are effective for preventing youth use. Following Juul’s removal of flavours in the US, youth did not stop vaping but instead switched to tobacco, mint and menthol flavours. Additionally, there has yet to be any data to suggest Nova Scotia’s flavour ban had any impact on youth vaping rates.
“We are saddened that another province has refused to take the time to get vaping regulation right. This decision was made using flawed and, in some cases, completely inaccurate information about vaping. As a final warning to the province, a new study has found that San Francisco, an early adopter of flavour bans, has had a 30% increase in youth smoking rates. I will be sending an official letter to the Premier ensuring that when the results of San Francisco are replicated in New Brunswick, the Premier acknowledges responsibility as a supporter of this bill,” said Darryl Tempest, Executive Director of the CVA.
The CVA has shared the research and the science on vaping. This government has knowingly and willingly ignored the facts. The result of the ban will be a flood of black-market products, an increase in cigarette sales and smoking related deaths. These consequences must be acknowledged.
TORONTO, June 11, 2021 /CNW/ - Ontario's doctors will be joining many others in cautiously taking part in patio dining, larger outdoor gatherings and other activities permitted in the first stage of the province's reopening plan today.
But the Ontario Medical Association urges everyone to avoid closed spaces, participate only in what is permitted with the new guidelines and continue with existing public health measures to ensure the third wave of COVID-19 was the final wave.
The OMA encourages everyone to get vaccinated as soon as they can. It asks the government to continue to focus vaccination efforts on hotspots where the highly contagious Delta variant remains a threat.
"Like many Ontarians, we are excited to begin the process of recovery and reopening," said OMA President Dr. Adam Kassam. "We know that the outdoors and seeing loved ones is vital to our well-being. Being fully vaccinated is crucial to ending this pandemic, and we encourage all Ontarians to book their next vaccine appointment as they become eligible."
About the OMA
The Ontario Medical Association represents Ontario's 43,000 plus physicians, medical students and retired physicians, advocating for and supporting doctors while strengthening the leadership role of doctors in caring for patients. Our vision is to be the trusted voice in transforming Ontario's health-care system.
SOURCE Ontario Medical Association
Parents say the pandemic has introduced new mental health challenges in their children
OTTAWA, June 09, 2021 (GLOBE NEWSWIRE) -- A new poll shows 62 per cent of parents say the pandemic has worsened the mental health challenges of their children, and 48 per cent say it has even introduced new mental health challenges where none previously existed.
The survey, commissioned by the Inspiring Healthy Futures initiative and conducted by Abacus Data, also shows the majority of parents expect longer-term residual effects of the pandemic on their children’s mental health, even after it ends.
“While the numbers are alarming, they are not surprising,” said Emily Gruenwoldt, President and CEO of Children’s Healthcare Canada and Executive Director of Pediatric Chairs of Canada. “These concerns from parents match what we are seeing in children’s hospitals across the country: record numbers of children visiting the hospital with mental health concerns, many of whom did not have any identified symptoms before the pandemic.”
According to the poll, only a quarter of parents say they have received enough support from governments during the pandemic, and the vast majority would like to see a variety of policy solutions to address child and youth mental health and broader well-being.
“As the end of Canada’s public health crisis lies ahead, what we are going to see left behind it is a children’s crisis,” said Lisa Wolff, Director of Policy and Research for UNICEF Canada. “Inspiring Healthy Futures presents a roadmap for recovery; for how Canada can address their immediate needs, and make sure children, youth and families are our collective focus for the long haul.”
The Inspiring Healthy Futures report is the result of eight months of consultations, including more than 1,500 voices from across the country. Youth, parents, service providers, youth-serving agencies, educators and researchers co-created inclusive, accessible, and flexible policy solutions to tackle child and youth post-pandemic recovery proactively and sustainably.
You can read the Inspiring Healthy Futures vision here.
About
About the survey The survey was conducted by Abacus Data with 2,000 Canadians, including 456 parents of children under 18, from May 26 to 28, 2021. A random sample of panelists was invited to complete the survey from a set of partner panels based on the Lucid exchange platform. These partners are typically double opt-in survey panels, blended to manage out potential skews in the data from a single source.
The margin of error for a comparable probability-based random sample of the same size is +/-2.17 per cent and 4.58 per cent respectively, 19 times out of 20.
The data were weighted according to census data to ensure that the sample matched Canada’s population according to age, gender, educational attainment, and region. Totals may not add up to 100 due to rounding.
About UNICEF Canada’s One Youth UNICEF Canada’s One Youth is working to make Canada the best place in the world to grow up. As the global UN agency for kids, UNICEF has worked to improve conditions for every child around the world for 75 years, and has saved more children’s lives than any other humanitarian organization. UNICEF Canada’s One Youth brings that work to Canada by measuring child and youth well-being, and advocating for the right to a childhood.
About Children’s Healthcare Canada Children’s Healthcare Canada is a national association representing health service delivery organizations serving children and youth across the continuum of care. Through purposeful partnerships, Children’s Healthcare Canada accelerates excellence and innovation in health systems caring for children and youth.
About Pediatric Chairs of Canada Pediatric Chairs of Canada represents the Department Heads (Chairs) of Pediatrics within the 17 Canadian medical schools. Collectively they provide national leadership in research and education to promote the health and healthcare of children and youth in Canada.
Canadian Medical Auctions Launches First Auction in Toronto, Canada
TORONTO, June 9, 2021 /CNW/ - Canadian Medical Auctions, dedicated to the re-marketing and auction of surplus healthcare equipment, is delighted to announce their official launch, as the first specialized medical equipment auction house in Canada.
Part of the BMA Group, Canadian Medical Auctions facilitates the collection, asset management and sale of used medical equipment to 10,000 buyers in more than 60 countries worldwide.
EVP and COO Helen Wilks leads the Canadian Medical Auctions team. "Transparency and flexibility in service are at the heart of our operations. The CMA team are thrilled to be partnering with hospitals, clinics, manufacturers and healthcare providers to help realize maximum market value for surplus equipment," she said. "We offer a very local and personal service, while facilitating access to a dynamic international marketplace. It's an exciting time to present a unique opportunity for Canadian healthcare providers to take advantage of the group's established global reach, using our service to alleviate traditional challenges that come with managing used equipment."
President and founder, Markus Grad, is behind BMA Group's expansion to North America. "Our exponential growth has been evident in the UK and more recently France – and expanding across the Atlantic was the logical next step for us," he explained. "Our international proposition is derived from a desire to give a wider audience access to realising the full potential of their surplus assets, alongside continuing to satisfy our ever-growing buyer demand for purchasing used medical devices and equipment."
With the auction model, both buyers and consignors benefit from the transaction. When bidding, the buyer sets the price they are willing to pay, while sellers receive the highest true market value.
A key motivation behind the group - and one that has received a welcome reception across Canada so far - is the sustainability impact. "Historically, surplus equipment has often been destroyed, involving high levels of landfill," says Wilks. "As we all rightly focus more on the circular economy, this service to prolong the life of surplus medical assets is a timely one for Canada".
Canadian Medical Auctions is this week pleased to kick-off of their first timed medical equipment auction, taking place now until Wednesday June 16th, 2021 at 11:00 a.m. EST. The auction is held online, with the equipment located at their warehouse in Oakville, Toronto. 240+ lots include ventilators, dialysis machines, ultrasounds, ECG machines, spectrometers and much more. To view the catalogue and bid, visit https://www.canadianmedicalauctions.ca.
Canadian Medical Auctions is Canada's specialist medical equipment auction house. Dedicated to managing surplus, obsolete, end-of-line and decommissioned medical equipment from all healthcare environments, Canadian Medical Auctions holds regular online auctions and private sales, catering to more than 10,000 buyers in over 60 countries.
SOURCE Canadian Medical Auctions
OMA estimates pandemic backlog of almost 16 million health-care services
TORONTO, June 9, 2021 /CNW/ - The COVID-19 pandemic has created a backlog of almost 16 million health-care services, or more than one for every Ontario resident, according to new estimates taken from OHIP data and released today by the Ontario Medical Association.
The OMA compared OHIP billings for six procedures in 2020 and the same period in 2021, and found the estimated backlog was greatest for MRIs (477,301), followed by CT scans (269,683), cataract surgery (90,136), knee (38,263) and hip (16,506) replacements and coronary artery bypass grafts (3,163).
"Three serious waves of infections have created a lengthy backlog of surgeries, diagnostic exams and other health-care procedures," OMA President Dr. Adam Kassam said Wednesday.
"We have also heard from community-based family doctors and specialists, who are reporting conditions that were left undiagnosed during the pandemic as patients avoided seeking help. Some conditions have grown more serious as non-COVID patients waited longer for treatment."
The pandemic backlog is more pronounced in community settings over hospitals, suggesting that while Ontarians have been actively getting their COVID vaccinations they have been deferring visits with their family doctors where they could have been screened and treated for chronic conditions.
Highlights:
Total estimated backlog of 15.9 million health-care services across all services and settings
The backlog is greater in community settings (9.6 million) than in hospitals (6.5 million)
Clearing the backlog working at 120 per cent would take:
22 months for knee replacements
21 months for cataract surgeries
14 months for hip replacements
10 months for cardiac surgery
10 months for MRIs
4 months for CT scans
The OMA has posted an infographic with this information at the bottom of this page.
The pandemic backlog estimated by the OMA is in addition to the wait list for procedures that existed before the pandemic began.
The OMA is developing recommendations on how to address the backlog so that Ontario patients can get the care they need as quickly as possible.
The OMA data follows a recent report by the province's Financial Accountability Office that showed it will take more than three years and $1.3 billion to clear the backlog of surgeries and diagnostic procedures. Ontario's Science Table said in April that almost a quarter million Ontarians were waiting for surgery.
Addressing the surgery backlog will require supportive services such as home care, long-term care and primary care as the pandemic's impacts reach beyond operating rooms.
Ontario's doctors expect the demand for mental health and addictions care will exist and grow for years after the CVID-19 pandemic. Mental health diagnoses attributed to the 1918 Influenza Pandemic continued for six years after it ended.
"The pandemic has created a significant backlog of services and procedures that will require a multi-disciplinary and collaborative approach to address," said OMA CEO Allan O'Dette. "The OMA is committed to working closely with government and other allied health professionals on practical solutions to wait times for diagnostic tests and treatments that Ontarians need."
About the OMA
The Ontario Medical Association represents Ontario's 43,000 plus physicians, medical students and retired physicians, advocating for and supporting doctors while strengthening the leadership role of doctors in caring for patients. Our vision is to be the trusted voice in transforming Ontario's health-care system.
SOURCE Ontario Medical Association
Recovering the Momentum of Reusables in Retail: Report
VANCOUVER, BC, June 9, 2021 /CNW/ - New research from the National Zero Waste Council, in collaboration with the University of Toronto's Dalla Lana School of Public Health, sheds light on the safe use of reusable items in retail settings during the COVID-19 pandemic.
"Prior to the COVID-19 pandemic, items like refillable mugs and reusable shopping bags were becoming ubiquitous, in line with growing public concerns about single-use items and the negative impacts of plastic waste on marine ecosystems," said Jack Froese, Chair of the National Zero Waste Council. "While the pandemic has slowed down the progress on reusables, we now know that there are many opportunities to recover the momentum without compromising public safety."
As part of the national response to COVID-19, public health authorities across Canada issued precautionary guidelines and directives for retail establishments to limit viral transmission risk. The specific guidelines varied widely between jurisdictions and many retailers adopted even more cautious policies. This response, coupled with the fact that the science around viral surface transmission is still emerging, contributed to uncertainty around the safety of reusable options and noticeably diminished the presence of reusable bags, containers and utensils in retail settings — particularly in the early months of the pandemic.
The National Zero Waste Council sought to better understand the risk of reusables during the pandemic, as well as the long-term implications for their viability in retail settings. The council approached the research team from the University of Toronto's Dalla Lana School of Public Health for its expertise in epidemiology, environmental and occupational health, public health policy and waste studies.
A summary of Canadian public health authorities' guidance with respect to the use of reusables
A review of current scientific evidence, available as of January 2021, regarding the transmission of COVID-19 via contaminated surfaces
An examination of changes in consumer and retailer behaviours with respect to reusable items
The research team concluded that as long as precautions remain in place, reusable items may be used in retail settings during the COVID-19 pandemic.
"The science shows us that items such as reusable bags, containers and cutlery do not pose any higher risk of virus transmission in retail settings than disposable items, as long as appropriate safety precautions are in place," said Pete Fry, Chair of the National Zero Waste Council's Product Design and Packaging Working Group. "This research will be welcomed by the many local governments that are working to reduce waste, and looking for a science-based understanding of the risks of using reusables during the COVID-19 pandemic in order to establish best practices for retailers and consumers in their communities."
Transitioning to reuse-based products and services presents significant opportunities. According to the council's 2021 report, Waste Prevention: The Environmental and Economic Benefits for Canada, replacing 20 per cent of single use packaging with reusable packaging could prevent more than 300,000 tonnes of plastic waste in Canada per year, representing a $773-million economic opportunity.
Webinar — June 24, 2021
Interested to learn more about opportunities to use reusables during the COVID-19 pandemic? Join a webinar on June 24, from 10 to 11:30 a.m., to hear public health researchers and industry experts discuss opportunities to reintroduce and accelerate the use of reusables in retail settings. Register here: nzwc.ca/events/reusables-in-retail/
About the National Zero Waste Council
The National Zero Waste Council, an initiative of Metro Vancouver, is leading Canada's transition to a circular economy by bringing together governments, businesses and NGOs to advance a waste prevention agenda that maximizes economic opportunities for the benefit of all Canadians.
SOURCE National Zero Waste Council
Fraser Institute News Release: Funding hospitals based on patient services means better health care for Canadians
VANCOUVER, British Columbia, June 10, 2021 (GLOBE NEWSWIRE) -- Paying hospitals based on services provided to patients, instead of allocating pre-defined annual budgets, could improve the quantity and quality of health care services while reducing wait times for Canadians, finds a new study released today by the Fraser Institute, an independent, non-partisan, Canadian public policy think-tank.
“The way we fund hospitals in Canada matters a great deal when it comes to how many patients are treated, and how we either encourage or discourage hospitals to be more efficient and productive,” said Nadeem Esmail, senior fellow at the Fraser Institute and author of Understanding Universal Health Care Reform Options: Activity-Based Funding.
The study highlights the potential improvements in health care when hospitals are funded on a per patient service basis—also known as activity-based funding.
Currently, hospitals across Canada are predominantly funded with lump sum payments, known as global budgets, regardless of how many patients are treated or what treatments are performed. This actually incentivizes hospitals to treat fewer patients to avoid exceeding budgets.
But when hospitals are paid a pre-defined amount of money for each patient cared for based on their particular condition and unique care needs, it creates powerful incentives to treat more patients. In other words, when “money follows patients”, patients transform from a drain on hospital budgets into a source of revenue.
Crucially, nearly every other developed country with a universal health-care system has moved towards activity-based funding in recent decades, whereas Canada is among the last to continue to use lump sum payments.
And among those universal health care countries that have switched to per patient services hospital funding, activity-based funding has been found to improve access to services, improve cost efficiency and increase transparency all without necessarily increasing total expenditures.
“The evidence from around the world is very clear—changing the incentives for hospitals improves care for patients,” Esmail said.
“While governments might prefer global budget funding for its administrative simplicity, it serves neither the interests of patients nor the interests of taxpayers who fund their care,” said Esmail.
Flair Airlines Begins Service with the First of 13 New Boeing 737-8 Aircraft
The growing ULCC starts passenger service with inaugural flight from Edmonton to Toronto
EDMONTON, Alberta, June 10, 2021 (GLOBE NEWSWIRE) -- Flair Airlines, Canada’s only independent ultra low-cost carrier (ULCC), begins service today with the first of 13 new Boeing 737-8 aircraft joining the fleet as the airline begins rapid growth to provide affordable, low fare air travel to 19 Canadian destinations.
“Today marks a huge milestone as Flair grows to bring affordable travel options to more Canadians,” says Stephen Jones, President and CEO, Flair Airlines. “Canadians have been paying too much for too long, and Flair is changing that thanks to the addition of the new 737-8 aircraft which provide us the efficiencies and ability to scale our service. Today’s inaugural flight kicks off our rapid growth.”
The inaugural flight of Flair’s first new 737-8 will depart Edmonton at 5:30pm MT and arrive in Toronto at 11:20 pm ET. Piloting the inaugural flight will be two veteran leaders at Flair: Captain Matt Kunz, Vice President, Business Transformation and Operations, and Captain Harold Knop, Regulatory Compliance and Certification Manager.
The new aircraft allow Flair to achieve the lowest cost per seat mile of any Canadian airline. The aircraft will deliver fuel savings and cut the airline’s CO2 emissions by 14%. Lower per passenger emissions are a vital step in lowering Flair’s carbon footprint as it works to become Canada’s greenest and most sustainable airline.
Flair’s pilots, maintenance professionals, flight attendants and safety officers have been conducting extensive testing and training programs to prepare for the addition of the new aircraft. Flair’s team has been working closely with Boeing and been on-site throughout the testing and delivery phase of each aircraft.
Flair began taking delivery of the 13 new aircraft in May. The 737-8 aircraft are joining Flair’s existing fleet of 737-800 aircraft and deliveries continue throughout 2021. By the middle of next year, Flair will have a fleet of 16 aircraft and be well on the way to achieving its “F50” ambition of growing to 50 planes within five years.
About Flair Airlines
Flair Airlines is Canada’s only independent Ultra Low-Cost Carrier (ULCC) and is on a mission to liberate the lives of Canadians by providing affordable air travel that connects them to the people and experiences they love. With an expanding fleet of Boeing 737 aircraft, Flair is growing to serve 19 cities across Canada. For more information, please visit www.flyflair.com
RYAH Group, Inc Publishes Report on Medical Cannabis Use for Pain
TORONTO, June 10, 2021 (GLOBE NEWSWIRE) -- via InvestorWire -- RYAH Group, Inc. (CSE:RYAH) (“RYAH” or the “Company”) is pleased to announce that its wholly owned subsidiary, RYAH Medtech Inc. ("RYAH Medtech"), has published a data report on use of medical cannabis among patients with pain conditions. The data report features insights into the use of cannabis to treat pain conditions by patients within the RYAH Data ecosystem and whether cannabis may be one of the alternative treatment solutions to reduce opioid use-related problems associated with existing treatment options. The publication is based on user feedback provided by more than 40,000 patients that have reported to the RYAH Data ecosystem.
The report provides a breakdown based on patient gender, main conditions related to pain management and corresponding strain types and reveals that pain is one of the top three conditions for medical cannabis treatment within the RYAH Data ecosystem and also seems to be one of the most interesting symptoms for researchers. As of the date hereof, one of the world’s largest clinical trials in cannabis is focused specifically on pain management, and further to RYAH's recent press release, the RYAH Smart Dry-Herb Inhaler has been selected as the device for such study (with RYAH Medtech recently having completed its initial shipment of RYAH Smart Dry Herb Inhalers and RYAH Cartridges to the U.K. clinic conducting the study).
“The RYAH data report on cannabis use for pain management comes at a turning point as studies on alternatives to opioids in treatment and potential efficacy of chronic pain start to accelerate,” says Gregory Wagner, CEO of RYAH. “The opioid crisis, which began with initially good intentions to more effectively treat pain, created a flood of opioids being prescribed, up from an estimated 70 million prescriptions in the 1990s to more than 255 million by 2012. RYAH is committed to providing the tools needed to effectively monitor and measure dosing in plant-based medicine treatments and to providing data analytics in order for the industry to make more informed decisions around alternative treatments to opioids."
About RYAH Group, Inc.
RYAH Group, Inc. (“RYAH”) is a connected device and big data and technology company focused on valuable predictive analysis in the global medical plant and nutraceutical intake industry. Its robust artificial intelligence platform aggregates and correlates HIPAA-compliant patient data, which is intended to help doctors and patients personalize plant-based treatments to better predict treatment outcomes. The data collection is relevant for clinics, doctors, dispensaries and pharmaceutical companies and licensed processors (LPs) to monitor and manage formulation effects on patients and demographics. With a strong IP portfolio, RYAH gathers deep and insightful data on the complete patient session and formulation life cycle.
Forward-Looking Statements
Certain statements contained in this press release constitute “forward-looking information” as such term is defined in applicable Canadian securities legislation. The words “may,” “would,” “could,” “should,” “potential,” “will,” “seek,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “expect” and similar expressions as they relate to the Company are intended to identify forward-looking information. All statements other than statements of historical fact may be forward-looking information. Forward-looking statements in this news release include statements relating to (i) cannabis as a possible alternative treatment option for various pain conditions; (ii) the previously announced study undertaken by the U.K. clinic on the safety and efficacy of cannabis and hemp for the treatment of patients suffering from chronic pain; and (ii) the size of the medicinal cannabis market. Readers are further cautioned that the assumptions used in the preparation of such forward-looking statements, including, but not limited to, the assumption that (i) the Company's financial condition and development plans do not change as a result of unforeseen events; (ii) there will continue to be a demand and market opportunity for the Company and its subsidiaries' product offerings and/or for cannabis as a potential alternative treatment option for various pain conditions; (iii) current and future economic conditions will neither affect the business and operations of the Company nor its ability to capitalize on anticipated business opportunities; and (iv) the previously announced study undertaken by the U.K. clinic has the potential to lead to results beneficial to the Company's business, although considered reasonable by management of the Company at the time of preparation, may prove to be imprecise and result in actual results differing materially from those anticipated, and, as such, readers are cautioned not to place undue reliance on forward-looking statements.
Forward-looking information reflects the Company’s current views and intentions with respect to future events and current information available to the Company and is subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements that may be expressed or implied by such forward-looking information to vary from those described herein should one or more of these risks or uncertainties materialize. These risks include, without limitation, risks associated with or inherent in (i) the general business and economic conditions in the regions in which the Company operates; (ii) the ability of the Company and its subsidiaries to execute on key priorities (including completion of acquisitions and strategic plans and the retention of key executives); (iii) the ability of the Company to integrate newly acquired businesses; (iv) the expected benefits of RYAH’s user-generated, HIPAA-compliant data and the anticipated results and experience users may receive from using RYAH products; (v) the Company's ability to implement business strategies and pursue business opportunities; (vi) disruptions in or attacks on (including cyber-attacks) the Company’s information technology, internet, network access or other voice or data communications systems or services; (vii) the evolution of various types of fraud or other criminal behavior to which the Company is exposed; (viii) the failure of third parties to comply with their obligations to the Company or its affiliates; (ix) changes to, or the application of, laws and regulations, legal and regulatory risks inherent in the cannabis industry; and (x) cannabis-related products manufactured for human consumption (including potential product recalls). Should any such factor affect the Company in an unexpected manner, or should assumptions underlying the forward-looking information prove incorrect, the actual results or events may differ materially from the results or events predicted. The forward-looking information included in this press release is made as of the date of this press release and is expressly qualified in its entirety by this cautionary statement. The Company undertakes no obligation to publicly update or revise any forward-looking information, other than as required by applicable law.
This press release includes market and industry data that has been obtained from third-party sources, including industry publications. The Company believes that the industry data is accurate and that its estimates and assumptions are reasonable, but there is no assurance as to the accuracy or completeness of this data. Third-party sources generally state that the information contained therein has been obtained from sources believed to be reliable, but there is no assurance as to the accuracy or completeness of included information. Although the data is believed to be reliable, the Company has not independently verified any of the data from third-party sources referred to in this press release or ascertained the underlying economic assumptions relied upon by such sources.
PharmaTher Provides Research and Development Update and Milestones for 2021
TORONTO, June 10, 2021 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to provide an update on the research and development initiatives of its psychedelic product programs and upcoming milestones for 2021.
“We are well-positioned, both financially and operationally, to execute on our remaining milestones for 2021, which includes completing a Phase 2 study with ketamine to treat Parkinson’s disease, a Phase 2 study with KETABET™ for treatment-resistant depression, and the development of our novel microneedle patches for delivering psychedelics such as ketamine, psilocybin, DMT, MDMA and LSD,” said Fabio Chianelli, CEO of PharmaTher. “The recent FDA acceptance of our IND to proceed to a Phase 2 study in Parkinson’s disease will pave the way for us to confidently submit future IND’s and advance clinical studies evaluating novel uses, formulations and delivery forms of psychedelics to treat various mental health, neurological and pain disorders.”
FDA Phase 2 Clinical Studies
For the rest of 2021, PharmaTher will focus on advancing three promising developments through clinical studies:
Ketamine for Parkinson’s Disease
Following the FDA acceptance of the Company’s investigational new drug application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease, the Company has begun clinical trial start-up activities to begin enrolling patients in Q3-2021 and to announce clinical results in Q4-2021.
For those interested in the study (ClinicalTrials.gov Identifier: NCT04912115), titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson's Disease,” please visit https://clinicaltrials.gov/ct2/show/NCT04912115?term=PharmaTher&draw=2&rank=1.
Assuming the Phase 2 clinical trial is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway in 2022.
KETABET™ for Treatment-Resistant Depression
The Company is preparing a pre-IND meeting request and briefing documents to submit to the FDA to support the clinical development of KETABET™ and the Phase 2 study for treatment-resistant depression. The Company intends to file the pre-IND meeting request this month, obtain FDA feedback on its clinical study design, and file the IND in Q3-2021.
With the overlap of the clinical operations from the Parkinson’s disease study, the Company has already activated start-up activities and identified potential clinical sites to screen and enroll patients for the proposed Phase 2 study in Q3/Q4-2021. The aim is to share clinical results by the end of this year.
Amyotrophic Lateral Sclerosis (“ALS” or “Lou Gehrig’s Disease”)
Following the Company’s recent submission to receive orphan drug designation for ketamine to treat ALS, the Company is working with its clinical advisors in finalizing a proposed Phase 2 study design. The objective is to request a pre-IND meeting with the FDA in Q3-2021 and submit the IND in Q4-2021.
PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS, which was discovered by Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O. Preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.
Microneedle Patch for the Delivery of Psychedelics
For the second half of 2021, PharmaTher will focus on working with its research and development partners to advance next generation microneedle patches for the delivery of psychedelics:
Hydrogel-Forming Microneedle Delivery System for Ketamine
PharmaTher is working with Professor Ryan Donnelly under a research agreement with The Queen’s University of Belfast to finalize the patented hydrogel-forming microneedle patch development to deliver ketamine and KETABET™.
The research leverages the successful proof of concept achieved in delivering esketamine, the S(+) enantiomer of ketamine, via the microneedle patch, which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format. Details of the research can be found in a published paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery.”
Validation and tech transfer to support clinical studies will be completed in Q4-2021. Interim development results will be made available as they arise throughout 2021.
Microdosing Psychedelics with GelMA Microneedle Delivery System
The Company is working with the Terasaki Institute, led by Dr. Ali Khademhosseini, under a research agreement to finalize the development of a proprietary microneedle delivery system comprised of a biocompatible and biodegradable gelatin methacryloy (“GelMA”) composite for use with psychedelics such as psilocybin, DMT, MDMA and LSD.
The GelMA patch delivery system is the driving force of the Company’s psychedelics microdosing program. It is expected that validation results in delivering these psychedelics will be completed in Q4-2021. Interim development results will be made available as they arise throughout 2021.
Clinical Manufacturing and Supply
The Company entered into a Co-Development Agreement with TSRL, Inc. to jointly develop a patented hydrogel-forming microneedle patch delivery technology licensed from The Queens University of Belfast, to control the manufacturing and supply of microneedle patches for the Companies respective clinical and commercial drug programs.
PharmaTher is focused on incorporating psychedelics (i.e. ketamine, psilocybin, DMT, MDMA and LSD) and TSRL is focused on incorporating antiviral medications (i.e. Zanamivir, other antiviral therapeutics and vaccines) in a microneedle patch with the potential to improve the safety (i.e. fewer side effects), efficacy (i.e. bioavailability, optimized dosing regimen including continuous system delivery) and compliance (i.e. storage, distribution and self-administration) of these compounds that currently must be taken orally, inhaled, injected and intravenously.
Recent activities included the tech transfer for scale-up and manufacturing of clinical supplies to a GMP contract research lab and a pre-IND meeting with the FDA that achieved agreement with the agency on proposed 505(b)2 product development plans.
The Company aims to validate clinical production of the microneedle patch this year and to enter into clinical studies in 2022 to deliver certain psychedelics such as ketamine, psilocybin, DMT, MDMA and LSD.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics to treat mental health, neurological and pain disorders. PharmaTher is currently conducting an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics. Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
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Cautionary Statement
This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the period of February 28, 2021 ("MD&A"), dated April 28, 2021, which is available on the Company's profile at www.sedar.com.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
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