Khiron Corporate Update: Company Reports Accelerated Increase in Medical Cannabis Prescriptions
Khiron reaches more than 3,500 medical cannabis prescriptions filled
Medical cannabis prescriptions increased by over 450% in Q3, compared to Q2 of 2020
Khiron's clinics exceeded 9,000 monthly patient consultations in September, marking a return to pre-pandemic monthly levels, supported by the launch of telehealth consultations
Khiron was declared a National Strategic Project by the Government of Colombia in September, accelerating its ability to register and introduce new SKUs in the medical cannabis and consumer-packaged goods categories
Khiron became the first company to sell medical cannabis in Peru, introducing its new CBD brand AlexinTM, sold under its previously announced agreement with Farmacia Universal, the largest compounding pharmacy in Peru
In September, the Company signed partnerships with 15 clinics and health centres in Colombia, extending education and sales reach further across the country
As the exclusive LatAm provider, Khiron began sales of medical products to patients participating in Project Twenty21 in the UK, the largest medical cannabis patient registry in Europe
Medical cannabis e-learning platform introduced in UK in partnership with the Medical Cannabis Clinicians Society, an independent, clinician-led organization sharing guidance to lead the medical cannabis conversation in the UK
Khiron's e-learning program accelerates medical cannabis knowledge for doctors participating in Project Twenty21, which now includes over 9,000 registrants
TORONTO, Oct. 9, 2020 /CNW/ - Khiron Life Sciences Corp. ("Khiron" or the "Company") (TSXV: KHRN), (OTCQX: KHRNF), (Frankfurt: A2JMZC), a vertically integrated cannabis leader with core operations in Latin America and Europe, is pleased to provide a corporate update on its global medical cannabis operations, including accelerating growth of 450% in its Colombian medical cannabis prescriptions, first sales in the UK, and entry into the Peruvian market.
"We have been saying for some time that we are in the execution phase of our business strategy. Measurable developments over recent weeks substantiate our approach and importantly, the ability of our team to execute on the plan. Despite the impact of the global pandemic, our medical cannabis sales are seeing accelerated growth in Colombia, with more than 3,500 prescriptions now filled. In addition, we supplied medical cannabis to Project Twenty21 participants in the UK, and began medical cannabis sales in Peru. Further, as a result of our timely adoption of technology-based solutions, clinic consultations returned to pre-pandemic monthly levels in September," comments Alvaro Torres, Khiron CEO and Director.
About Khiron Life Sciences Corp. Khiron is a vertically integrated medical and CPG cannabis company with core operations in Latin America, and operational activity in Europe and North America. Khiron is the leading cannabis company in Colombia and the first company licensed in Colombia for the cultivation, production, domestic distribution and sales, and international export of both low and high THC medical cannabis products. The Company has filled medical cannabis prescriptions in Peru and has a presence in Mexico, Uruguay, UK, Spain and also in Germany, where it is positioned to begin sales of medical cannabis.
Leveraging its first-mover advantage and patient-oriented approach, Khiron combines global scientific expertise, product innovation, agricultural infrastructure, wholly-owned medical clinics, and online doctor education programs to drive prescription and brand loyalty to address priority medical conditions. Its Wellbeing unit launched the first branded CBD skincare brand in Colombia, with KuidaTM now marketed in multiple jurisdictions in Latin America, the US and UK. The Company is led by Co-founder and Chief Executive Officer, Alvaro Torres, together with an experienced and diverse executive team and Board of Directors.
This press release may contain certain "forward-looking information" and "forward-looking statements" within the meaning of applicable securities legislation. All information contained herein that is not historical in nature may constitute forward-looking information. Khiron undertakes no obligation to comment on analyses, expectations or statements made by third-parties in respect of Khiron, its securities, or financial or operating results (as applicable). Although Khiron believes that the expectations reflected in forward-looking statements in this press release are reasonable, such forward-looking statement has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Khiron's control, including the risk factors discussed in Khiron's Annual Information Form which is available on Khiron's SEDAR profile at www.sedar.com. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Khiron disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.
Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.
SOURCE Khiron Life Sciences Corp.
Pedal for Kids Raises $225,891 to Support Families at the Children's!
Event participants rose to the occasion despite today's uncertain climate.
MONTREAL, Oct. 9, 2020 /CNW Telbec/ - The Montreal Children's Hospital Foundation is happy to announce that the 2020 special edition of Pedal for Kids raised $225,891 for the Children's young patients and their parents, who need support now more than ever. Despite the many challenges posed by COVID-19, organizing committee members, participants and donors worked together to ensure the success of the Foundation's flagship event.
A year unlike any other!
The 17 participating teams – most of them from the private sector – weren't able to take their traditional ride through the streets of downtown Montreal, so they celebrated their fundraising efforts safely with a virtual event on Saturday, September 26. The event Co-presidents, Rudy Azoulay and Eddy Farrace, expressed their gratitude. "Although they couldn't participate in team-building activities with their colleagues, over 360 participants demonstrated their commitment in an inspirational way," said Mr. Farrace. "Given the unprecedented situation, the $225,891 raised for the Healthy Kids Fund is even more remarkable," added Mr. Azoulay.
The Healthy Kids Fund supports the Hospital's most urgent needs, allowing our medical experts to offer essential care to countless young patients who desperately need it, now and beyond the pandemic. "The participants' support for our young patients and their families is invaluable, especially now. It's reassuring to be able to count on the generosity of a whole community and our precious donors to help the Children's find unexpected ways to heal," said Renée Vézina, the Children's Foundation president.
Now more than ever, funds raised will make all the difference for sick children like Daniel, the event spokeschild. When Daniel was born, his parents were concerned to learn that he was deaf. At the age of three, the boy started the process for a bone anchored hearing aid (BAHA) implant, a procedure that would require four surgeries at the Children's. "The implant allowed me to hear, like everyone else," explained Daniel. "And it's all thanks to generous people like the Pedal for Kids participants."
The teams
Over the past 29 years, Pedal for Kids has brought together hundreds of thousands of people, as well as hundreds of businesses and community groups, raising over $13 million for sick children. From the bottom of our hearts, we thank this year's participating teams: Air Canada Vacations, AppDirect, Colliers International, Cossette, Daniel's Ride, Deloitte, Harrison's Ride, Jarislowsky Fraser, Jean Fortin & Associates, Morgan Stanley, Osler, Paysafe Group, Rio Tinto, Robinson Sheppard Shapiro, Scotiabank, TD Wealth Management, Tecsys Inc.
The organizing committee
Year after year, the organizing committee's dedication, essential to the success of Pedal for Kids, is an inspiration to the Children's Foundation. Given this year's unprecedented situation, we are especially grateful to them. For their tireless work, we would like to thank the members of the committee: Eddy Farrace, Rudy Azoulay, Michael Conway, Paul Normandin, John Lukca, Anthony Pepper, Michel Théroux, Johanne Sabourin and Suzanne Eissa.
ABOUT PEDAL FOR KIDS
Pedal for Kids began in 1992 when Sylvie Lalumière and Michael Conway decided to raise funds in memory of their daughter Meagan, who received treatment at the Montreal Children's Hospital. 29 years later, almost 300 000 cyclists and 200 participating teams have contributed to save lives. Their support is essential to the improvement of pediatric care, and equally to the innovation of several treatment centres, including the Wake-up Centre, the Family Resource Centre, the Psychiatry Department, the Adolescent Clinic and the Craniofacial and Cleft Palate Unit. For more information, please visit Pedal For Kids.
ABOUT THE MONTREAL CHILDREN'S HOSPITAL FOUNDATION
The mission of the Montreal Children's Hospital Foundation is to inspire and mobilize the community to support innovation in research, teaching and care at the Montreal Children's Hospital, the pediatric teaching hospital for McGill University's Faculty of Medicine, and pediatric research at the Research Institute of the McGill University Health Centre. The Children's Foundation has launched the largest fundraising campaign for a pediatric hospital in Quebec's history, with a goal of $200 million to advance innovative projects that will push the envelope in pediatrics on an international scale and help the Children's Find Unexpected Ways to Heal. Since its inception in 1973, the Foundation has raised over $500 million, which has transformed the lives of sick children through innovative research and teaching projects, and cutting-edge care. For more information, please visit childrenfoundation.com.
SOURCE The Montreal Children's Hospital Foundation
GREY STATE ANNOUNCES LAUNCH OF ANTIMICROBIAL* PROTECTIVE FACE COVERINGS WITH HEIQ V-BLOCK
Grey State, in Collaboration with HeiQ, to Develop Masks Enhanced with HeiQ V-Block Technology New York, NY -October 9, 2020-Designed in response to the current pandemic, Grey State created a collection where comfort is key, and safety is paramount. The protective collection is made with comfortable fabrics with antimicrobial*, detachable face masks to complement, not complicate fashion. The face masks are enhanced with innovative HeiQ V-Block -a Swiss antimicrobial* technology which provides protection for fabrics against microbes. HeiQ V-Block technology does not irritate the skin and is non-toxic. HeiQ V-Block is US EPA registered, OEKOTEX® certified, ZDHC and bluesign® homologized. Treated textile articles are compliant with US FIFRA. "During these uncertain times, safety and comfort become top priorities when it comes to purchases. Physically and emotionally, consumers crave items that provide both reassuring comfort and a defense against external threats." Founder and CEO Saima Chowdhury states, "Here at Grey State, we offer our new 'Protective Collection'-combining both needs and offering customers items they can reach for day after day to provide built-in protection." Known for effortless style, the "Protective Collection" is an assortment of sweatshirts and hoodies crafted from the same supple fabrics for which the brand is known. Terry, eco-fleece, recycled cotton, jersey, modal and poplin in a soft, neutral color palette are accented with stars, camo, and tie-dye for a luxurious and laidback look. Zippered hood pockets and removable masks offer convenience and comfort in knowing that protection is within reach. The collection retails from $88-$98 and is available exclusively at https://greystateapparel.com/. With a focus on responsible manufacturing, Grey State continues to adhere to the UN's sustainability goals to ensure apparel is produced with the highest standards. Therefore, with every purchase one dollar is donated to One Tree Planted. For more information, visit https://greystateapparel.com/. * Antimicrobial properties built in to protect the product. This product does not protect users or others against human pathogens including bacteria, viruses, germs or other disease organisms. Link to Imagery Here About Grey State:At Grey State we make clothes that fit both your body and life. Our mission is to help you move through life with ease, comfort, and style. Grey State is owned and operated by women who empower other women, and care deeply about people and the planet. We believe that everybody in our supply chain deserves fair wages, healthy working conditions, and a sense of dignity about their work. We also work hard to keep our environmental impact as low as possible. We're not perfect, but we believe that small actions can make a big impact. Welcome to an entirely new state of being. About HeiQ:Founded in 2005 as a spin-off from the Swiss Federal Institute of Technology Zurich (ETH), HeiQ is a leader in textile innovation creating some of the most effective, durable, and high-performance textile technologies on the market today. HeiQ's purpose is to improve the lives of billions of people by perfecting an everyday product: Textiles. Combining three areas of expertise - scientific research, specialty materials manufacturing and consumer ingredient branding - HeiQ is the ideal innovation partner to create differentiating and sustainable textile products and capture the added value at the point of sale. With a total capacity of 35'000 tons per year HeiQ manufactures in the USA, Switzerland and Australia serving its chemical specialties in over 60 countries worldwide.HeiQ, Viroblock and HeiQ Viroblock are trademark(s) or registered trademark(s) of HeiQ Materials AG. The use of these trademark(s) is subject to approval from HeiQ.
4 Ways to Improve Your Breathing and Stamina for Cold Weather Runs
A brisk run in cold weather can be invigorating for many people. However, it can also be tough to complete a set goal if a runner isn’t making the most of their lungs or doesn’t seem to have the stamina to last. Here are just four possible ways people who enjoy running in the cold might manage their breathing and stamina reserves.
Be Consist
Before you work on any of the ways to control your breathing and improve your stamina, you should start here. You need to make a true commitment to yourself and ensure that you will maintain your regimen once you start. It is a good idea to start with small, intense training sessions that progress naturally to broader workouts with more volume.
Build Muscle Slowly
Even if you’re ready to tackle the longest run of your life, it is a good idea to start with small gains that you can build on incrementally over time. You can get a set of weight room equipment that should have everything you might need to start working on the core and limbs. Building up muscle allows your body to do more for longer periods, and it goes right along with working on proper breathing exercises. Strength training can also help to reduce the risk of general injury.
Alter Rest Times
All training for stamina should have built-in rest times that allow your body to recover from the intensity of the workouts. You should consider relatively lengthy recovery times if you are not used to strength or stamina training at first. After you feel improvements, you can set tighter limits on the wait times between sessions.
Use Heart Rate Data
Monitors that keep track of your heart rate during runs are not brand new, but many people still run with nothing more than standard athletic gear. This approach is fine, but there’s no reason not to take advantage of some of the modern technology that can specifically benefit a runner looking for stamina gains. In most cases, these monitors will collect data that will tell you how efficient your body is at doing hard work and recovering from it. You can track improvements by following the changes in this data.
Like any physical training, improving your stamina or breathing won’t take place overnight. It may take a few days before you start to notice any results, and you might need to incorporate more than one tip into a regular exercise routine to get the outcomes you want. Don’t forget that there are several types of running you can do in cold weather, and you can increase your stamina for different sets depending on your preferences.
Brooke Chaplan is a freelance writer and blogger. She lives and works out of her home in Los Lunas, New Mexico. She recommends looking into unflavored CBD animal tinctures for your pet. For more information, contact Brooke via Facebook at facebook.com/brooke.chaplan or Twitter @BrookeChaplan
Russell Alexander Law Firm Offers Tips for Divorcing in Ontario During the Coronavirus Pandemic
Lawyers say couples should be prepared, as courtroom procedures have changed
LINDSAY, Ontario —With marriages strained by the coronavirus pandemic, interest in divorce is spiking. But divorce lawyer Russell Alexander warns that couples seeking to separate need to be prepared for a much different process than that which pre-dated the pandemic. Alexander is author of the new book, “Everything You Always Wanted to Know About Divorce, ” which he delayed the release of just to include a special bonus chapter on divorcing during a pandemic.
Courtroom procedures have changed due to social distancing requirements, while backlogs have made cases move slower than ever. Everyone from lawyers to judges will be communicating through videoconferencing apps.
“The process of going through a divorce has undergone a dramatic transformation since March,” said Alexander, who founded the Russell Alexander Collaborative Family Lawyers which has offices throughout Ontario. “It’s harder, takes longer and can be more frustrating. That’s why we recommend working together instead of going to court.”
Russell Alexander Collaborative Family Lawyers has long helped clients find alternatives to messy and expensive courtroom battles, but Alexander said that a collaborative approach is more important than ever. With courtrooms facing a backlog of cases, divorces are taking longer and even when couples get time before a judge they are often talking through videoconferencing apps, which can make the process more stressful.
Alexander recommended that anyone seeking a divorce make sure that they have an up-to-date computer and high-speed internet in order to videoconference with their lawyers and court officials; consider alternatives to going to court; and be patient as the process unfolds.
“Divorce is never easy, but divorcing during a pandemic is going to be more stressful than usual as it drags on,” added Alexander. “If you don’t try a collaborative approach, you may find the pandemic is over before your marriage.”
Thebook, “Everything You Always Wanted to Know About Divorce,” is available to purchase online at Amazon, Barnes & Noble and Apple Books, as well as through Bibliotheca, Rakuten Kobo, Tolino and Baker & Taylor. Readers may also pick up a copy at the list price of $22.12 at the firm’s six offices throughout Ontario. All proceeds will be donated to theGiving Fundin support of various community-based programs.
These Brands Rally For World Mental Health Day & Beyond!
World Mental Health Awareness Day is Saturday, October 12th. According to the CDC 40% of US adults reported struggling with mental health or substance use during the peak of the Covid-19 pandemic. Now more than ever, it is important to not only be mindful of our own mental health but also the mental health of those around us. To further bring awareness to mental health Yunizon, OH.SOand TAFT are proud to donate a portion of proceeds to select mental health charities and support awareness year round.
Yunzion Eyewear will donate 15% of all proceeds to the National Alliance on Mental Illnessand will give you 15% off your order.Founders, Rebecca Lay and Kimberly Van-Schoyck created the brand with the goal to bring mental health awareness to the forefront of the fashion industry. The brands core principles: free expression, inclusivity and belonging create an environment that is free of inhibitions and judgment, resulting in a sense of belonging that is fundamental to human satisfaction. We see a balanced state of mind as key to promoting these principles and are advocates for mental health initiatives. In line with this, we donate a portion of our proceeds to the National Alliance on Mental Illness. We are committed to being part of the solution because we are all "Under One Sun".
OH.SO will donate 25% of proceeds to the American Foundation for Suicide Prevention. Selfcare collection OH.SO takes mental health seriously. This year, the brand has committed to donating 25% of proceeds to the American Foundation for Suicide Prevention. The brand's mission is to make people feel OH.SO good about what we put on our bodies. Products are free from any chemicals, cruelty, GMOs or gluten. This California-based collection uses high quality natural ingredients, essential oils and colloidal silver - which is powerful enough to kill bacteria and odor-causing germs on contact but gentle enough for even the most sensitive skin.
TAFT offers free mental health services for all employees and gives back to the Crisis Text Line. DTC men's shoe brand, TAFT clothing, advocates for Mental Health all year long. In addition to free mental health services for all employees, the brand also gives back to the Crisis Text Line. Founder Kory Stevens, who has struggled with depression, uses TAFT as a platform for mental health advocacy and to connect directly with his customers, who may be facing similar challenges. Both Kory and his wife are involved with Room Here, an organization reframing the conversation around mental fitness.
What to Do When Faced With Chronic Ankle Rolling
Chronic ankle rolling can put you at risk for suffering recurring sprains. It can also be harder for you to walk and complete your daily activities. If you are an athlete or someone who works out frequently, then you are more likely to suffer from chronic ankle rolling. Fortunately, there are many ways that you can treat this problem.
Get Physical Therapy
Your doctor may recommend that you get physical therapy. Physical therapy can help strengthen the tendons and muscles in your ankle. Your physical therapist can have you perform a variety of exercises. They can also use various modalities, such as ultrasound, heat, ice and electrical stimulation. Furthermore, your physical therapist can tailor your treatment to match the sports and activities that you do.
Wear the Right Shoes
If your ankles are rolling regularly, you likely have weak ankles. This means that even when your ankles feel healthy, they are missing important muscular structures that help keep them steady. Wearing the right shoes when you walk can help with this. Motion control and arch support found in sports shoes are very useful for those with weak or pronating ankles and help give support while your muscles grow.
Ankle Braces
If your ankle rolling is severe and the ankle itself is still in the process of healing, wearing an ankle brace can give the support you need. These help keep your ankle straight while you walk, which can be uncomfortable, but it is necessary if you want your ankle to heal properly. If your ankle isn’t showing any improvement with a brace, make sure you speak with a doctor to see if more serious measures need to be taken.
Medication
Over-the-counter medications, such as Advil or Tylenol, can help you treat chronic ankle rolling. They can help alleviate pain and inflammation. If you have less inflammation, then it will be easier for you to heal. However, it is important to note that over-the-counter medications are not meant to be used for long periods of time. You can also soak your ankle in Epsom salts to help reduce the swelling and relax tight muscles.
Surgery
If non-surgical treatments are not working, then it is time to talk to your doctor. They may recommend that you get surgery as a last resort. A surgeon can repair the damaged tendons and ligaments. Your activity level and severity of the instability will determine the type of surgery that you need. The recovery time can also vary.
It can be a lot harder for you to complete simple tasks if you suffer from chronic ankle rolling. However, you can treat this condition by getting physical therapy. You can also take an Epsom salt and use an ankle brace. Medication is another thing that can be helpful. If home treatments do not work, then it may be time to get surgery.
Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs
Lilly submitted request for emergency use authorization (EUA) for monotherapy to U.S. Food and Drug Administration (FDA)
New data show combination therapy met primary and secondary endpoints, reducing viral load, symptoms and hospitalizations; EUA request to follow
Plan to initiate a large open-label pragmatic study in COVID-19 outpatients in October
Media and investor call to be held at noon EDT today
TORONTO, Oct. 8, 2020 /CNW/ - Eli Lilly and Company (NYSE: LLY) yesterday announced additional details on its SARS-CoV-2 neutralizing antibody programs – including interim data on combination therapy in recently diagnosed patients with mild- to moderate COVID-19 – and plans to make these therapies broadly available to patients.
The pace of this development program is unprecedented," said Dr. Doron Sagman, Lilly Canada's vice president of R&D and Medical Affairs. Lilly's highly skilled and dedicated scientific teams have made significant advances in a very short period of time. These data offer initial evidence that these antibodies could be an effective treatment for COVID-19 and that they could be available for medical use in the near future."
Investors, media and the general public are invited to review a webcast that took place yesterday at noon EDT, where Lilly provided more data and discussion on these programs. The webcast information is available here.
Combination therapy clinical trial data
Data from a new interim analysis of the BLAZE-1 clinical trial showed that combination therapy with two of Lilly's SARS-CoV-2 neutralizing antibodies reduced viral load, symptoms, and COVID-related hospitalization and ER visits. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in the outpatient setting. The combination cohort enrolled recently diagnosed patients with mild- to moderate COVID-19, who were assigned to 2800 mg of each antibody (n=112) or placebo (n=156).
The combination therapy significantly reduced viral load at day 11 (p=0.011), meeting the primary endpoint of the study. Most patients, including those receiving placebo, demonstrated near complete viral clearance by day 11. Further, combination treatment reduced viral levels at day 3 (p=0.016) and day 7 (p<0.001)—earlier time points during the course of infection when higher viral loads are typically seen. Combination therapy also significantly reduced the time-weighted average change from baseline from day 1 to 11. An exploratory analysis showed that the proportion of patients with persistent high viral load at day 7 for combination therapy was lower (3.0 percent) versus placebo (20.8 percent), corresponding to a nominal p value of p<0.0001 without multiplicity adjustment. No emergent putative resistance variants have been observed thus far in patients treated with combination therapy.
Combination therapy also met prespecified clinical endpoints, including the time-weighted average change from baseline in total symptom score from day 1 to 11 (p=0.009). The improvement in symptoms was observed as early as three days after dosing and was similar in magnitude and timing to improvements previously seen with LY-CoV555 monotherapy. The rate of COVID-related hospitalization and ER visits was lower for patients treated with combination therapy (0.9 percent) versus placebo (5.8 percent), a relative risk reduction of 84.5 percent (p=0.049). This was also similar to observations for LY-CoV555 monotherapy.
Combination therapy has been generally well tolerated with no drug-related serious adverse events. In LY-CoV555 monotherapy studies there have been isolated drug-related infusion reactions or hypersensitivity that were generally mild (two reported as serious infusion reactions, all patients recovered). Treatment-emergent adverse events were comparable to placebo for both LY-CoV555 monotherapy and combination therapy.
Lilly is working to publish the monotherapy and combination therapy data in peer-reviewed journals as soon as possible.
Manufacturing and supply update
To be able to quickly provide treatment to patients around the world, Lilly invested in large-scale manufacturing of both antibodies at risk – even before data demonstrated their potential to become a meaningful therapeutic option for COVID-19.
For monotherapy, Lilly is focused on the 700 mg dose of LY-CoV555 since similar clinical effects were seen across all dose levels tested in BLAZE-1. Lilly anticipates it could supply as many as one million doses of 700 mg LY-CoV555 monotherapy in Q4 2020, with 100,000 available in October. With respect to the supply of combination therapy, Lilly anticipates it will have 50,000 doses available in Q4 2020. The supply of combination therapy will increase substantially beginning in Q1 2021, as additional manufacturing resources come online throughout the year, including Lilly's recently announced manufacturing collaboration with Amgen (NASDAQ: AMGN). Lilly is also pursuing additional partnerships to provide antibodies to resource-limited countries.
Regulatory update
Based on the combination therapy data, along with the previously disclosed findings for LY-CoV555 monotherapy, Lilly has engaged global regulators, including the FDA, regarding potential Emergency Use Authorization (EUA). Lilly has now submitted an initial request to the FDA for EUA for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild- to moderate COVID-19. We expect to submit a subsequent request for EUA for combination therapy in November, pending clinical trial enrollment, once additional safety data accumulate and sufficient supply is manufactured. Lilly anticipates having data to support a biologics license application (BLA) submission for combination therapy as early as Q2 2021. Conversations with global regulators, including Health Canada, are ongoing.
The BLAZE-1 clinical trial (NCT04427501) continues to enroll a confirmatory cohort of higher-risk patients who have been recently diagnosed with mild- to moderate COVID-19, testing the ability of the antibody combination to reduce the number of patients with persistently high viral load and reduce COVID-related hospitalizations. In addition, Lilly is studying lower doses of combination therapy and alternative delivery options in planned or ongoing clinical trials. Other ongoing clinical trials include a Phase 3 study of LY-CoV555 monotherapy for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987). In addition, LY-CoV555 monotherapy is being tested in the National Institutes of Health-led ACTIV-2 and ACTIV-3 studies of ambulatory and hospitalized COVID-19 patients. Data from these other ongoing trials are not yet available. Thus far, over 850 trial participants have been dosed with LY-CoV555 (alone or in combination with LY-CoV016), contributing to the safety data supporting this potential treatment.
Open-label pragmatic study in COVID-19 outpatients
To generate additional efficacy and safety data, Lilly plans to initiate a pragmatic, open-label study in the coming weeks, enrolling patients treated with either monotherapy or combination therapy, with a focus on collecting data regarding hospitalizations, deaths and safety.
Moving forward, LY-CoV555 and LY-CoV016 will be referred to as bamlanivimab and etesevimab, respectively.
About BLAZE-1
BLAZE-1 (NCT04427501) is a randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of LY-CoV555 and LY-CoV016 for the treatment of symptomatic COVID-19 in the outpatient setting. To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion.
The monotherapy arms of the trial enrolled patients recently diagnosed with mild- to moderate COVID-19 in studying three doses of LY-CoV555 (700 mg, 2800 mg, and 7000 mg) versus placebo. The combination arm of the trial enrolled patients recently diagnosed with mild- to moderate COVID-19 in studying LY-CoV555 2800 mg plus LY-CoV016 2800 mg versus placebo. Placebo patients were shared across all therapy arms in the completed cohorts.
The primary outcome measure for these completed arms of the BLAZE-1 trial was the change from baseline to day 11 in SARS-CoV-2 viral load. Additional endpoints include the percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.
The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll an estimated 800 participants.
About bamlanivimab (LY-CoV555)
LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19. LY-CoV555 emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed enrollment and primary safety assessments of LY-CoV555 in a Phase 1 study of hospitalized patients with COVID-19 (NCT04411628) and long-term follow-up is ongoing. A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Lilly recently initiated a Phase 3 study for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987). In addition, LY-CoV555 is being tested in the National Institutes of Health-led ACTIV-2 and ACTIV-3 studies of ambulatory and hospitalized COVID-19 patients.
About etesevimab (LY-CoV016)
LY-CoV016 (also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can effectively block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. A SARS-CoV-2 challenge study was conducted in rhesus macaques and showed LY-CoV016 is effective for both prophylactic and therapeutic venues against SARS-CoV-2 infection. Lilly licensed LY-CoV016 from Junshi Biosciences after it was jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.
Lilly has successfully completed a Phase 1 study (NCT04441931) of LY-CoV016 in healthy U.S. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. LY-CoV016 has been well tolerated and no drug-related severe adverse events (SAEs) have been observed to date.
About Lilly's COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19.
About Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.
Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.
For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA.
SOURCE Eli Lilly Canada Inc.
ParaTough Cup: Home Edition encourages Canadians to try Para sport at home in support of athletes with a disability
Paralympic Foundation of Canada launches home edition of flagship fundraising event this month
Funds raised provide opportunities for people with a disability to access sport
OTTAWA, ON, Oct. 7, 2020 /CNW/ - The Paralympic Foundation of Canada is launching an innovative at-home version of its signature fundraising event this month, revamping its format due to the COVID-19 pandemic to encourage people across the country to try out some Para sport-inspired challenges from their own homes. ParaTough Cup: Home Edition fuelled by Petro-Canada™ will kick off October 9, raising funds to provide more opportunities for people with a disability to try sport at all levels.
"As we are not able to gather in person right now, we are excited to make this year's edition of ParaTough Cup nationwide and for Canadians to have the chance to experience activities that have been inspired by Para sport and hopefully have some fun with it," said Dean Brokop, Director, Paralympic Foundation of Canada. "Everyone in Canada should have access to sport, and funds raised through ParaTough Cup are critical to growing sport opportunities for people with a disability. Thank you in advance to everyone who supports ParaTough Cup this year; your support is so valued and is making a difference in the lives of many athletes with a disability."
Typically held in four cities across Canada each year – Toronto, Montreal, Calgary, and Vancouver – ParaTough Cup first began in 2017 in Toronto and officially crossed the $1 million threshold raised with its final event in early 2020. The event gives participants real-world experience of Para sport, trying multiple sports alongside their fundraising teams with the assistance of Para athletes onsite.
For the home edition, anyone can partake in ParaTough Cup by trying any of three adapted sport challenges – sitting volleyball, Para ice hockey, and wheelchair basketball. Demonstrated in videos by Para athletes, each challenge has been designed so they can be completed from the safety of one's own home or local park.
Wheelchair Basketball Demonstrated by Tara Llanes, member of the Canadian women's national team and Lima 2019 Parapan Am Games gold medallist, and attempted by Nicolas-Guy Turbide, Para swimmer and Rio 2016 Paralympic Games bronze medallist
Sitting Volleyball Demonstrated by Shacarra Orr, Rio 2016 Paralympian and Tokyo 2020 athlete ambassador, and attempted by Rob Armstrong, member of Canadian national Para ice hockey team and PyeongChang 2018 Paralympic Games silver medallist
Para Ice Hockey Demonstrated by Billy Bridges, member of Canadian national team, five-time Paralympian and three-time Paralympic medallist (one gold, one silver, one bronze), and attempted by Melanie Labelle, member of Canadian national wheelchair rugby team and Lima 2019 silver medallist
Participants are asked to challenge, donate and share: record a video of themselves trying one of the sport challenges, donate online or via text, and then share their #ParaTough attempt on social media – perhaps even challenging their friends and family to do the same.
"ParaTough Cup is such an exciting event and the home edition is an awesome chance for everybody to get a little taste of how challenging yet incredibly fun Para sport is," said wheelchair basketball's Tara Llanes. "I really encourage people to try it out for themselves and donate even if it's just $5, $10, or $20. Sport has been my life and all people with a disability in this country should have the chance to play or compete – whether it's getting out there to be healthy and active or compete at a high level and represent Canada like me."
Anyone can donate via Paratoughcup.ca/donate or by texting PARATOUGH to 41010 to make a one-time donation of $10, $20, or $25. Together, Pfizer and ParaTough Cup: Home Edition presenting sponsor Petro-Canada, a Suncor business, will also donate $1 every time the hashtag #ParaTough is used on social media, up to a maximum of $30,000.
In addition, individuals can create their own fundraising pages and encourage their networks to donate, with prizes awarded based on fundraising totals and the top five fundraisers receiving a ParaTough Cup: Home Edition trophy. A silent auction will run online from October 19-30 as well.
ParaTough Cup: Home Edition will officially kick off on October 9. For more information, please visit Paratoughcup.ca.
The Paralympic Foundation of Canada is a registered charitable foundation and the philanthropic arm of the Canadian Paralympic Committee. Founded in 2015, the PFC believes that every single Canadian should be able to imagine themselves at the start line, regardless of ability. Funding provided by the PFC is critical to supporting and providing more opportunities to Para athletes and programs across the country.
SOURCE Canadian Paralympic Committee (Sponsorships)
Morneau Shepell launches unified telemedicine solution to enhance Canadians' total wellbeing
Company enters growing telemedicine market through its LifeWorks' business
TORONTO, Oct. 7, 2020 /CNW/ - Morneau Shepell, Canada's largest provider of wellbeing and mental health solutions, has expanded into the rapidly growing telemedicine market to provide the employees of Canadian clients and their families with easier, more convenient access to digital health care services.
Telemedicine is viewed today as a transformational development in improving access and reducing the costs of health care. To access this market opportunity, the company is launching a unified telemedicine service through its LifeWorks' business to provide Canadians with quick access to medical practitioners such as doctors, nurse practitioners, and other clinical professionals across the wellbeing spectrum.
"Telemedicine will shape the future of health care through consumer-grade platforms that unify and simplify the end-to-end patient experience, marrying digital scale with human personalization," said Neil King, president of LifeWorks and executive vice president of Morneau Shepell. "Today millions of employees and their families turn first to Morneau Shepell for support on a wide range of wellbeing issues. We have a unique opportunity to support their needs with a new generation of unified telemedicine solutions. It's a natural fit in our total wellbeing portfolio."
The new unified telemedicine solution, which can be accessed via the company's award-winning LifeWorks' platform, will deliver a comprehensive set of telemedicine capabilities that provide:
Faster access to care for patients wherever they are – anywhere.
A simplified patient experience, including easy onboarding and ongoing follow-up.
Access to multiple consultation approaches.
Integration into a continuum of care spanning multiple health care modalities.
Available in Canada now, telemedicine will be offered as an additional service within the LifeWorks' employee and family assistance programs, creating an integrated approach to total wellbeing.
About Morneau Shepell Morneau Shepell is a leading provider of technology-enabled HR services that deliver an integrated approach to employee wellbeing through our cloud-based platform. Our focus is providing world-class solutions to our clients to support the mental, physical, social and financial wellbeing of their people. By improving lives, we improve business. Our approach spans services in employee and family assistance, health and wellness, recognition, pension and benefits administration, retirement consulting, actuarial and investment services. Morneau Shepell employs approximately 6,000 employees who work with some 24,000 client organizations that use our services in 162 countries. Morneau Shepell is a publicly traded company on the Toronto Stock Exchange (TSX: MSI). For more information, visit morneaushepell.com.
SOURCE Morneau Shepell Inc
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