Get “Screen Overloaded” Kids Outside – with the Help of TurfMutt!

Alexandria, Va. - School is back in session for students around the country – and many kids, if attending school from home, are spending lots of time online and in front of screens.

Mutt Mulligan (“Mo-Mo”), a rescue dog who is “pawing it forward,” reminds us that enjoying time in the parks and yards nearby is good for us and for the planet. As the official spokesdog of the TurfMutt Foundation, Mo-Mo knows a thing or two about yards – and the boundless energy that many children need to expend outdoors.

Right now the safest place to spend time may be your personal green space – your yard. It can help your children de-stress, widen their play area, and build up knowledge in science and math. Mutt Mulligan offers tips to help make the most of your yard as an outdoor classroom.

Tip #1: Get outside throughout the day. Take a 20-minute break between classes at home, head out to the backyard and breathe some fresh air. During a lunch break, take a quick visit to the park. After spending a long day indoors, encourage children to get outside to enjoy the family yard.

Tip #2: Notice the different kinds of plants in your yard. Take kids around the outside of your home. Encourage them to take notes and sketch what they see. How is the landscape changing this time of year? What animals or birds might be nesting in or feeding on plants in the yard as the season progresses? What makes your yard unique from the others in the area? Draw the living (plants, trees, grass) and the non-living (patios, grills) parts of your landscape.

Tip #3: Learn about the world beneath little feet. Explain that one of the benefits of plant-filled green spaces is that they provide habitats, or natural homes, for many different creatures. Look for birds, bees and other creatures that have made both urban and suburban neighborhoods their home. Use a magnifying glass to help your child explore what lives in the grass or is resting on shrubs and trees.

Tip #4: Map out the living landscapes in your neighborhood. Go on a living landscape hunt. Walk around your neighborhood with your child and sketch the living landscapes, creating a map with symbols for trees, bushes, flowers and grass. You can also add markers for animal or insect habitats, or water sources.

Tip #5: Make a nature journal. Get some paper or a notebook and keep a record of when your family is outside and what you do when you are there. It can be as simple as jotting down the date and the activity you did outside, or as detailed as adding sketches of plants or animals observed, and more. Review the journal at dinnertime or weekly to see how much time you spent outside.

Tip #6: Put the right plant in the right place. If you’ve decided to add some new plants to your yard as a family activity, check the USDA Plant Hardiness Zone Map to find out what plants are best for where you live. Use a mix of native and adaptive plants and place them where they will thrive – a teachable moment for children!

Tip #7: Visit TurfMutt.com to play games and read digital storybooks for free to learn more. The website for the TurfMutt environmental education and stewardship program for grades K-8 offers home-based activities, digital storybooks, lesson plans for families and teachers, and more.

About TurfMutt

TurfMutt was created by the Outdoor Power Equipment Institute’s (OPEI) TurfMutt Foundation and has reached more than 70 million children, educators and families since 2009. Through classroom materials developed with Scholastic, TurfMutt teaches students and teachers how to “save the planet, one yard at a time.” TurfMutt is an official USGBC® Education Partner and part of their global LEARNING LAB. TurfMutt is an education resource at the U.S. Department of Education’s Green Ribbon Schools, the U.S. Department of Energy, the U.S. Environmental Protection Agency, Green Apple, the Center for Green Schools, the Outdoors Alliance for Kids, the National Energy Education Development (NEED) project, Climate Change Live, Petfinder and the U.S. Fish and Wildlife Service. In 2017, the TurfMutt animated video series won the coveted Cynopsis Kids Imagination Award for Best Interstitial Series. TurfMutt’s personal, home habitat is featured in the 2017-2019 Wildlife Habitat Council calendars. More information at www.TurfMutt.com.

Experience the Freedom of Radical Self-Acceptance with Transformative Healing Method

Boston, MA, September 23, 2020 — Do you constantly wonder what you’re saying, doing or thinking that’s causing you to feel “less than”? Are you always looking for ways to fix something about yourself? You’re not alone—far from it, in fact—and the good news is that you have the power to find your way back to the person you know you are deep down. It’s been inside you all along. 

There Is Nothing to Fix: Becoming Whole through Radical Self-Acceptance from Suzanne Jones may be the last self-help book you will ever need. Jones has helped thousands of participants with her life-changing somatic healing program, and in her book she leads you on a journey back to your authentic self by guiding you through a personal exploration of recovery, growth and resilience. There Is Nothing to Fix is The Power of Now meets Brené Brown meets the #MeToo movement. Interspersed with case studies and stories of real people—stories you can connect with—the book illustrates the power of Jones’s approach to create innate healing and hope.

Jones begins where most teachings on self-compassion, emotional regulation and healthy relationships end, by going to the source of lasting change—the body. This book provides a practical lens through which readers can understand their responses and emotions while offering step-by-step guidance for changing these responses, all with an emphasis on compassion and empowerment. Through this revolutionary approach you will be able to experience true freedom from the constant urge to fixyourself from the outside. Jones teaches you everyday tools to build self-confidence, self-compassion and most important, self-acceptance—tools that have been within you all along.

In today’s struggle to feel connection and approval in our chaotic and critical world, There Is Nothing to Fix teaches us how to suspend judgment, become curious and find emotional freedom from within.

Suzanne Jones is an expert in the field of trauma recovery through somatic methods. She has presented workshops and talks at Omega Institute, Kripalu, mental and behavioral health facilities in the greater Boston area, and national conferences. She has been profiled on CNN and in Yoga Journal, the New York TimesShape and Whole Living, and she's been interviewed by author Rick Hanson for his Foundations of Well-Being online course. Jones founded the TIMBo Collective (formerly called yogaHOPE) in 2006 and developed the TIMBo program for transforming trauma in 2009. Since its launch, her program has been delivered to over 4,000 women in the U.S., Haiti, Kenya and Iran, and helped transform client care at organizations in Massachusetts; Washington, DC; and Georgia, serving women overcoming homelessness, addiction and domestic violence. Jones also writes a blog for the TIMBo Collective and Elephant Journal

There Is Nothing to Fix is her first book and has won a silver medal from the Nonfiction Author’s Association book awards, a bronze medal from the Wishing Shelf Book Awards, was a finalist in the International Book Awards and has been nominated for a 2020 Readers’ Choice award. 

For more information, please visit www.suejonesempowerment.com, or connect with the author on Instagram: @thereisnothingtofix; or on Facebook: There is Nothing to Fix.

There Is Nothing to Fix: Becoming Whole through Radical Self-Acceptance

Publisher: LAKE Publications 

ISBN-10: 1734083506 

ISBN-13: 978-1734083507

Available from Amazon.comAudible.comBarnesandNoble.com and Target.com

###

Immediate Resources Needed to Clear Backlog of Patient Services and Surgeries

TORONTO, Sept. 23, 2020  /CNW/ - Amid the rise in positive cases in Ontario, the Ontario Medical Association (OMA) is calling for an immediate and significant infusion of resources to address the extensive existing backlog in medically necessary patient services and surgeries so that the coming surge doesn't put us further behind.  

The OMA is encouraging the government to:

  • Designate and fund "COVID-19 hospital sites" within a region to isolate known COVID-19 cases from other patients and allow the remainder of hospitals to focus on addressing the backlog. 
  • Provide necessary resources to increase capacity and enable more procedures and services. These resources could include establishing Alternate Health Facilities, expanding Independent Health Facilities and out-of-hospital premises, and designating non-COVID-19 sites such as specialty hospitals, as well as keeping operating rooms open longer hours. 
  • Implement innovative funding models, such as expanding quality-based procedure funding to these facilities, as well as keeping operating rooms open longer hours. 
  • Undertake, with the OMA, comprehensive vaccination strategies and surge planning for hospitals. 
  • Make virtual care options permanent, more accessible and available for all appropriate health care needs. 
  • Provide mental health supports for physicians, who are not eligible for standard workplace programs. 
  • Provide support to keep community doctor's offices and clinics viable.

"Clearing this backlog is enormously challenging within our current model. It is essential that we look at innovative patient-focused solutions." said OMA President Dr. Samantha Hill. "Ontario's doctors are calling for immediate action to ensure patients receive the highest quality of care as quickly as possible." 

Pre-COVID-19, Ontario's doctors saw 340,000 patients a day. However, from March to the end of July, patients received 11.1 million fewer services from their physicians as compared with the same period last year – a reduction of 24 percent.  A September 1, 2020 paper published by the Canadian Medical Association Journal estimated that between March 15 and June 13, 2020, there was a backlog of 148,364 surgeries in Ontario, which would take 84 weeks to clear. 

After hours and weekend work for physicians is not enough to solve this problem alone.  There are only so many physicians who can perform these procedures and they were already working very long hours before the pandemic.

Until a vaccine or effective treatment for COVID-19 is found, physicians will be unable to see as many patients or perform as many surgeries per day due to increased infection control procedures including the extra time required to sanitize exam rooms and equipment between patients, change PPE, and maintain strict physical distancing protocols in waiting rooms. It will be extremely challenging to catch up on the backlog without a significant infusion of resources in the short term.

"Ontario's doctors have been working closely with the government throughout the pandemic to provide their unique expertise", said OMA CEO Allan O'Dette. "We are looking forward to learning more about the government's Keeping Ontarians Safe plan.  As an organization we want to continue working with the government to ensure patients have the best care possible by modernizing and integrating the health-care system. We need to apply our COVID lessons to create a safer, stronger, even more patient-centred system."        

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

Working and learning virtually is a stressful new reality, and those who still physically go to work/school are under entirely new stresses of safety concerns. Healthy Minds Innovations (HMI), has developed a free meditation App to teach you how the mind can be trained to be more focused, calm, and resilient through meditation training. Anyone can use the App as a tool to navigate everyday life including at school and the workplace. The Center for Healthy Minds at the University of Wisconsin-Madison and their non-profit, HMI, are both led byNeuroscientist Dr. Richard Davidson. He's spent years researching the science of well being. Dr. Cortland Dahl joined his team and used his PHD thesis to create a framework for four pillars of scientifically training the mind; called ACIP; Awareness, Connection, Insight, Purpose - details on that, below.
Any interest in speaking with Dr. Cortland Dahl? Dr. Dahl a Research Scientist at Center for Healthy Minds and Chief Contemplative Officer at HMI as well as the voice of the App.

Screen Shot 2020-07-10 at 2.18.32 PM.png

Path to a Healthy Mind; a process through Awareness, Connection, Insight and Purpose - or ACIP, as we call it. The science shows that well-being is a skill that can be improved and measured - here’s the basics:

  • Awareness: One step is to train your mind to be more calm and focused by practicing mindfulness and strengthening attention. These skills help us be more present in our relationships, and less distracted at work. They also help us notice our impulses and emotional reactions before they overwhelm us.
  • Connection: But mindfulness is just the beginning, we can also learn simple skills to build healthy relationships and foster caring interactions with other people. This starts by learning to be more compassionate to ourselves, and then extending kindness and appreciation to others. Eventually, we can even find ways to be more empathetic and caring in challenging and stressful situations.
  • Insight: One of the most powerful forms of practice is self-inquiry. The skill of self-inquiry helps us see how our thoughts, emotions, and beliefs shape our experience. This gives us deep insight that creates a flexible, resilient sense of self. We can hold our views and beliefs in a healthy way and let go of self-defeating attitudes and expectations.
  • Purpose: Our personal values and principles are central to well-being, and clarifying them is a skill we can practice in everyday life. This shift in perspective brings depth to our relationships, meaning to our work and pursuits, and gives us the inner resources to learn and grow from life’s challenging moments.


The Center for Healthy Minds at the University of Wisconsin-Madison conducts transformational scientific research on healthy qualities of mind and explores how these qualities might be cultivated on an individual and global scale.  For decades, Dr. Richard Davidson and the Center have investigated the science of emotions, contemplative practices and qualities of mind that are suspected to affect well-being, including attention, resilience, equanimity, savoring positive emotions, kindness, compassion, gratitude and empathy. Healthy Minds Innovations, Inc. (HMI) is a non-profit affiliated with the Center for Healthy Minds to turn these groundbreaking insights into action, with a mission to translate this science into tools to cultivate and measure well-being.  Our latest development is Healthy Minds @Work, a product designed to bring well-being to the workplace. The @Work offering is a fee-based service that includes use of the workplace-focused Healthy Minds Program app, live-trainings and customized back-end data reporting and measurement for management and HR professionals to access.

Screen Shot 2020-07-10 at 2.42.06 PM.png

The Cannabis That Helps Fight Cancer: This October, Autumn Brands Pledges Proceeds to the Breast Cancer Resource Center of Santa Barbara 

In honor of Breast Cancer Awareness Month, the majority-female managed cannabis cultivator takes a stand against a disease that affects nearly 1 in 8 women   

SANTA BARBARA, California – (September 22nd, 2020): In honor of Breast Cancer Awareness Month, 50% female-owned Autumn Brands invites customers to join in the fight - during the entire month of October, the company pledges $.50 cents from every jar featuring the pink tamper seal to the Breast Cancer Resource Center of Santa Barbara. Backed by decades of hard-won, sustainable farming expertise, pesticide-free Cannabis cultivator Autumn Brands stands out as a sixth-generation, family-run operation dedicated to clean growing practices that prioritize consumer safety and product quality. With a majority-female staff, the brand stands firm in its role as a neighbor, friend, and ally to the local Santa Barbara community in an effort to win the battle against a disease that affects nearly 1 in 8 women.   

Through constant innovation that goes above and beyond the industry standard approach, the Autumn Brands team remains committed to the wellbeing of the planet, its customers, and the close-knit community in which they farm. Integrating measures such as world-class air purification technology, along with operating on a closed-loop watering system that relies on no-spray greenhouse farming techniques, the brand continuously puts health and safety first. The result is a superior selection of sun-grown, hand-harvested flower lovingly cultivated to preserve its natural healing benefits and complement a variety of wellness goals, from pain relief and relaxation to mental focus and physical performance.

When customers choose from Autumn Brands’ premium selection of pesticide-free flower, pre-rolls, and pre-filled cartridges, they get far more than a top-quality toke; with each purchase, consumers play an important role in supporting a 50% female-owned and operated local business that actively seeks to promote good health and wellbeing for all. Plus, this October, selecting from Autumn Brands’ expertly curated leaf products featuring the pink tamper seal helps to raise awareness about breast cancer while providing essential support and wellness services to the local community through the Breast Cancer Resource Center of Santa Barbara.

Throughout the month of October, join in the fight against breast cancer by looking for Autumn Brands’ locally-cultivated glass jar cannabis flower with the pink tamper seal, available at select California dispensaries. Learn more about the Breast Cancer Resource Center of Santa Barbara at BCRCSB.org. Browse the Autumn Brands estate-grown selection and locate the nearest participating seller online at AutumnBrands.com. Follow @AutumnBrands on Instagram for the latest product releases and updates. 

# # #

About Autumn Brands:

Autumn Brands is a licensed California cannabis cultivator dedicated to the synergy of health and wellness. The Autumn Brands’ family farm started in Holland more than a century ago, and today, sixth-generation farmers apply the same expertise garnered in growing the world’s finest tulips to producing pure and potent strains of cannabis in sunny, coastal Santa Barbara County. Autumn Brands is proud to be 50 percent woman-owned, united by the vision of two families, free of pesticides and other harmful chemicals. For more information, visit www.autumnbrands.comor email leighanne@anderson-pr.com.

About Breast Cancer Resource Center:

The Breast Cancer Resource Center of Santa Barbara (BCRC) is a community resource center that empowers women who have been diagnosed with breast cancer to advocate for themselves and make informed decisions regarding breast health. At the BCRC women are heard and find emotional support in actively navigating their cancer treatment and survivorship health. Breast Cancer Resource Center is a registered 501(c)(3) nonprofit under EIN 91-1790842. Donations are tax-deductible to the fullest extent allowable under the law.

Common Injuries to Be Aware of When Starting a Workout Routine

Workout injuries can happen to anyone regardless of the fitness level or experience that you have. The good news is that you will learn how to mitigate them once you know the specific injuries. This way, the zeal to exercise and become fit will not burn out for you. Here are the common injuries that you need to know before you start exercising.

Ankle Sprain

Typically, an ankle sprain occurs when a ligament stretches beyond its limits or tears. When your foot rolls when doing jumping exercises, you will start to experience some pain. The affliction is usually accompanied by swelling, stiffness, tenderness, and bruising. When that happens, you need to see a podiatrist for immediate treatment to ease the inflammation.

Knee Injury

If you are lifting heavy weights, an injury can happen since you are putting pressure on your knees. Also, improper knee alignment during workouts can lead to harm. Therefore, you can avoid the pain by lifting weights that suit your body. You should align your knees well before engaging in lifting exercises.

Elbow Strain

It is also known as tendinitis since the harm causes inflammation to your tendon. You can get elbow strain when you repeatedly throw a ball or lift weights in a bid to get fit. If you are struggling to do arm exercises, the injury can occur. On that account, you need to take it easy on the workouts so that you won't have an elbow strain.

Shin Splints

The injury happens when the shinbone on your lower leg can't handle tough workouts anymore. It means that you will experience the pain when you overwork the bone tissue, muscles, and tendons on your leg. For instance, if you are riding a bicycle or running long miles, shin splints occur. Therefore, you can rest for a while or ice the shin to get rid of the pain.

Wrist Pain

Front squats can cause wrist pain, especially if you are using weights in the exercise. What's more, intensive push-ups can lead to injury since they place stress on your wrists. Hence, you can do light activities that don't strain your wrists for comfort.

Workouts are incredibly essential to keep your body healthy, but they come with risks. The secret is not to overdo the exercises since the injuries can cause a setback to your fitness groove. It would help if you started with light lifting so that your body can get accustomed to the machines slowly.

Drake’s Organic Spirits Enters Japan

Leading distiller of ultra-premium organic vodka and rum brings it Spiked Ice freeze-and-eat adult treats to Costco locations in the Land of the Rising Sun

Minneapolis, MN ( September 22, 2020 ) – Drake’s Organic Spirits announced today the launch of its popular Spiked Ice freeze-and-eat adult treats at all 27 Costco locations in Japan, which owns the world’s third-largest economy and is populated by over 125 million people.

Drake’s Organic Spiked Ice freeze and eat or chill and drink popsicles feature 15% ABV and only 80 calories each. Spiked Ice is available in four flavors - Mango Rum Punch, Vodka Lemonade, Watermelon Martini and Classic Mojito - and are made with Drake’s award-winning all-organic ultra-premium vodka and white rum.  They contain no artificial colors or flavors and freeze with twice the ABV as other brands. 

Adhering to Japan’s strict organic standards and requirements is the biggest hurdle for overseas firms trying to get a foothold in the nation. All Drake’s Organic Spirits are certified USDA organic, non-GMO Project Verified, gluten-free, vegan and kosher.  The five certifications ensure a cleaner drinking option that comes only from the highest quality organic ingredients. 

“We’re thrilled that consumers in Japan will now be able enjoy Drake’s highly-popular Spiked Ice treats,” said Drake’s Founder and CEO Mark Anderson.  “Japanese customers are extremely quality conscious and Japan was among the first countries to seek organic and non-gmo products. Spiked Ice is perfect for a market ready for our great tasting, high-quality organic certified spirits. Drake’s is still the only spirit brand in the world to hold all five health and wellness certifications.”

The launch of Drake’s Organic Spirits products in Japan was scheduled for earlier 2020 but delayed due to the global coronavirus pandemic.  A complete list of Costco locations in Japan can be found at https://www.costco.co.jp/store-finder .

About Drake’s Organic Spirits 
Minneapolis-based Drake’s Organic Spirits was launched in 2017.    Drake’s uses the highest quality USDA organic and non-GMO Project Verified ingredients to create a line of ultra- premium spirits and mixes. Drake’s Organic Vodka, Drake’s Organic White Rum and Drakes Organic Spiced Rum offer a no-grain, no-gluten, no-gmo, ultra-premium and 12-times distilled handcrafted spirits at a better price than the leading premium brands.  The company recently began producing bulk sanitizer to meet the need for cleaner, safer environments.

Drake’s Organic Premium Vodka was awarded Double Gold and Drake’s Organic White Rum  received Gold at the most recent Wine & Spirits Wholesalers of America (WSWA) Convention & Exposition in Orlando, FL.  The highly-respected awards are widely considered among the most prestigious in the industry because judges are industry experts who blind taste-test each spirit. 

For more information, please visit http://www.drakesorganicspirits.com, facebook: http://www.facebook.com/drakesorganic/, Instagram: @drakesorganic, or contact email sales: info@drakesorganicspirits.com.

Exercise before menopause is important to optimise health in later years

The small blood vessels in muscles of women after menopause are less able to grow compared to young women, according to new research published today in The Journal of Physiology. This means exercising before menopause is all the more important for women in order to develop blood vessels in muscles, and thus the ability to develop muscle strength.  

Recent studies have shown that there are some substantial differences in the way the blood vessels, which influences susceptibility to conditions like heart disease and stroke, are affected by aging and physical activity between women and men, a difference which to a large extent is related to the female sex-hormone, estrogen.   

Estrogen is protective of the heart and blood vessels in women for about half of their lives, but, at menopause, there is an abrupt permanent loss of estrogen, leading to a decline in the health of our blood vessels. 

In this study, the researchers at the University of Copenhagen examined the smallest of blood vessels in muscle, called capillaries. The number of capillaries in skeletal muscle can change a lot and is mainly affected by how much the muscle is used, such as during exercise. This is the first study to isolate and examine cells from skeletal muscle samples of young and old women. 

Capillaries in skeletal muscle (as opposed to heart muscle) are very important for skeletal muscle function, physical capacity and health as it is here that oxygen and nutrients, such as sugar and fats, are taken up into muscle when needed. It is known that loss of capillaries in muscle can affect insulin sensitivity and thereby the development of Type II diabetes.  

The study also found that, when the aged women completed a period of aerobic exercise training by cycling, they did not achieve an increase in the number of capillaries in muscle, in contrast to what has been repeatedly shown in young and older men. 

Aging is known to lead to a loss of capillaries in the muscle, an effect which, in men, has been shown to be counteracted by a physically active lifestyle. This new study suggests that women do not attain capillary growth as readily and that an underlying cause may be a flaw in the cells that make up capillaries.  

It is important to underline that both men and women have a vast benefit from being physically active throughout life, regardless of age, but the current study supports the idea that women may benefit from being physically active before menopause, while they still have estrogen, so that they have a good physical starting point as they get older.  

The researchers studied older women (over 60 years old) and young (around 25 years old) ones. The women underwent a series of physical tests, and the researchers obtained small samples from their thigh muscles.  

The muscle biopsies were used to isolate blood vessel cells and muscle cells for further detailed study in the lab. The older women then also conducted 8 weeks of cycling training, where they trained three times per week at moderate to high intensity.  

The women were tested for fitness and several other parameters before and after the training. After the training period samples were again obtained from the thigh muscle and used for analysis of capillary number and specific proteins. 

Line Nørregaard Olsen, first author on the study said: 

“Another aspect that is worth highlighting is that many people doubted that the older women could handle such intensive training. However, the women, who conducted the cycle exercise training (spinning training) 3 times per week for 8 weeks, with heart rates over 80% of maximal heart rate for more than 60% of the time, were excited and handled the training without problems. This underlines that the popular view of how hard women of that age can train should be revised. 

Notes for Editors 

  1. Full paper title: Link to paper https://physoc.onlinelibrary.wiley.com/doi/abs/10.1113/JP280189 (link will only work after the embargo date. Before then, please email the press office for a copy of the paper) 
  1. The Journal of Physiologypublishes advances in physiology which increase our understanding of how our bodies function in health and disease. http://jp.physoc.org  
  1. The Physiological Society brings together over 4,000 scientists from over 60 countries. The Society promotes physiology with the public and parliament alike. It supports physiologists by organising world-class conferences and offering grants for research and also publishes the latest developments in the field in its three leading scientific journals, The Journal of PhysiologyExperimental Physiology and Physiological Reportswww.physoc.org  

Clinical Data From Full Phase 1 Cohort of Investigational Sotorasib Published in New England Journal of Medicine

NSCLC Data Featured in Proffered Presentation Session at Virtual ESMO 2020

Manuscript Represents First Phase 1 Results Published for a KRASG12C Inhibitor

MISSISSAUGA, ON, Sept. 22, 2020 /CNW/ - Amgen has announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumours, were published in the New England Journal of Medicine (NEJM). Data from 59 patients with advanced non-small cell lung cancer (NSCLC) reported in the NEJM manuscript were also featured during an oral presentation at ESMO 2020. Please note the safety and efficacy of sotorasib is still under investigation and market authorization has not been obtained.

"We are pleased to present the updated Phase 1 results of CodeBreaK 100, the largest Phase 1/2, and first-in-human, clinical study for a KRASG12C inhibitor," said Dr. Suna Avcil, executive medical director, Amgen Canada. "This data, combined with data presented earlier this year, offers important insight into the development of therapeutic options for non-small cell lung cancer, advanced colorectal cancer, and other solid tumours."

A total of 59 patients with NSCLC were treated, of which 34 received the 960 mg daily dose (data cutoff of June 1, 2020). The data demonstrated confirmed objective response rate (ORR) and disease control rates (DCR) in these heavily pretreated patients.

Activity was seen across all dose levels in patients with NSCLC. Tumour shrinkage was assessed in patients at the first week-6 assessment. 

Tolerability in patients with NSCLC was consistent with previously seen CodeBreaK 100 results. No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events(TRAEs). The most common TRAEs were diarrhea (25.4%), alanine aminotransferase (ALT) increase (20.3%), aspartate aminotransferase (AST) increase (20.3%), fatigue (10.2%) and nausea (10.2%). Eleven (18.6%) patients had grade 3 or higher TRAEs, one of whom had grade 3 TRAEs of ALT and AST increases that led to discontinuation of treatment.

"KRAS G12C is a driver mutation that is central to the biology of non-small cell lung cancer, colorectal cancer and other solid tumours. Historically, this mutation has been considered un-druggable" said Dr. Adrian G. Sacher, M.D., M.M.Sc., F.R.C.P.C., Division of Medical Oncology & Hematology Princess Margaret Cancer Centre. "These findings provide important insight into therapies that may target KRAS G12C in metastatic non-small cell lung cancer."  

The ESMO oral presentation included Phase 1 NSCLC results published in NEJM, as well as data on potential biomarkers of response to sotorasib that demonstrated clinical activity across a range of KRAS G12C mutant allele frequencies (MAFs), PD-L1 tissues expression levels, tumour mutational burden (TMB) plasma levels and tissue co-mutational profiles.

About KRAS
The RAS gene family, which has been the subject of almost four decades of research, contains some of the most frequently mutated oncogenes in human cancers.[i],[ii] KRAS is the most prevalent variant within this gene family and is particularly common in solid tumours.  It also accounts for about 13 per cent of non-small cell lung cancers, three to five per cent of colorectal cancers and one to two per cent of numerous other solid tumours, making this among the most broadly represented mutations across cancer patient subgroups.[v],[vi],[vii],[viii],[ix]. With the discovery and exploitation of a unique surface groove in the KRASG12C protein, Amgen was able to advance the first investigational KRASG12C inhibitor into the clinic and is exploring the potential of KRASG12C inhibition across multiple tumour types.

About CodeBreaK
The CodeBreaK clinical trial program for Amgen's investigational drug sotorasib is designed to study patients with an advanced solid tumour with the KRAS G12C mutation.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumours. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumour type and stage of disease. The primary endpoint for the Phase 1 study is safety, and key secondary endpoints include objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day. 

Additional information about CodeBreaK clinical trials can be found at http://www.codebreaktrials.com.

About Amgen Canada

As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new ways of using existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca and follow us on www.twitter.com/amgencanadagm.

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene Ltd. or any collaboration or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2  or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat COVID-19), or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by Health Canada, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

References
[i]Cox AD, et al. Nat Rev Drug Discov. 2014;13:828-851.
[ii]Fernandez-Medarde A, et al. Genes Cancer. 2011;2:344-358.
[iii]Biernacka A, et al. Cancer Genet. 2016;209:195-198.
[iv]Stephen AG, et al. Cancer Cell. 2014;25:272-281.
[v]Neumann J, et al. Pathol Res Pract. 2009;205:858-862.
[vi]Jones RP, et al. Br J Cancer. 2017;116:923-929.
[vii]Wiesweg M, et al. Oncogene. 2019;38:2953-2966.
[viii]Canon J, et al. Nature. 2019;575:217-223.
[ix]Zhou L, et al. Med Oncol. 2016;33:32.
[x]Ryan MB, et al. Nat Rev Clin Oncol. 2018;15:709-720.

SOURCE Amgen Canada

Correction- EMBARGOED: Exercise before menopause is important to optimise health in later years

Peer reviewed                                                     Experimental study                                                                People 

UNDER STRICT EMBARGO UNTIL 01.00 GMT 23 SEPTEMBER 2020 

Not for publication or broadcast before this time  

The small blood vessels in muscles of women after menopause are less able to grow compared to young women, according to new research published today in The Journal of Physiology. This means exercising before menopause is all the more important for women in order to develop blood vessels in muscles, and thus the ability to develop muscle strength.  

Recent studies have shown that there are some substantial differences in the way the blood vessels, which influences susceptibility to conditions like heart disease and stroke, are affected by aging and physical activity between women and men, a difference which to a large extent is related to the female sex-hormone, estrogen.   

Estrogen is protective of the heart and blood vessels in women for about half of their lives, but, at menopause, there is an abrupt permanent loss of estrogen, leading to a decline in the health of our blood vessels. 

In this study, the researchers at the University of Copenhagen examined the smallest of blood vessels in muscle, called capillaries. The number of capillaries in skeletal muscle can change a lot and is mainly affected by how much the muscle is used, such as during exercise. This is the first study to isolate and examine cells from skeletal muscle samples of young and old women. 

Capillaries in skeletal muscle (as opposed to heart muscle) are very important for skeletal muscle function, physical capacity and health as it is here that oxygen and nutrients, such as sugar and fats, are taken up into muscle when needed. It is known that loss of capillaries in muscle can affect insulin sensitivity and thereby the development of Type II diabetes.  

The study also found that, when the aged women completed a period of aerobic exercise training by cycling, they did not achieve an increase in the number of capillaries in muscle, in contrast to what has been repeatedly shown in young and older men. 

Aging is known to lead to a loss of capillaries in the muscle, an effect which, in men, has been shown to be counteracted by a physically active lifestyle. This new study suggests that women do not attain capillary growth as readily and that an underlying cause may be a flaw in the cells that make up capillaries.  

It is important to underline that both men and women have a vast benefit from being physically active throughout life, regardless of age, but the current study supports the idea that women may benefit from being physically active before menopause, while they still have estrogen, so that they have a good physical starting point as they get older.  

The researchers studied older women (over 60 years old) and young (around 25 years old) ones. The women underwent a series of physical tests, and the researchers obtained small samples from their thigh muscles.  

The muscle biopsies were used to isolate blood vessel cells and muscle cells for further detailed study in the lab. The older women then also conducted 8 weeks of cycling training, where they trained three times per week at moderate to high intensity.  

The women were tested for fitness and several other parameters before and after the training. After the training period samples were again obtained from the thigh muscle and used for analysis of capillary number and specific proteins. 

Line Nørregaard Olsen, first author on the study said: 

“Another aspect that is worth highlighting is that many people doubted that the older women could handle such intensive training. However, the women, who conducted the cycle exercise training (spinning training) 3 times per week for 8 weeks, with heart rates over 80% of maximal heart rate for more than 60% of the time, were excited and handled the training without problems. This underlines that the popular view of how hard women of that age can train should be revised. 

ENDS 

Notes for Editors 

  1. Full paper title: Link to paper https://physoc.onlinelibrary.wiley.com/doi/abs/10.1113/JP280189 (link will only work after the embargo date. Before then, please email the press office for a copy of the paper) 
  1. The Journal of Physiology publishes advances in physiology which increase our understanding of how our bodies function in health and disease. http://jp.physoc.org  
  1. The Physiological Society brings together over 4,000 scientists from over 60 countries. The Society promotes physiology with the public and parliament alike. It supports physiologists by organising world-class conferences and offering grants for research and also publishes the latest developments in the field in its three leading scientific journals, The Journal of Physiology, Experimental Physiology and Physiological Reports. www.physoc.org