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.
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.
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.
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
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
BioCanRx Invests $10M in Promising New Cancer Immunotherapy Research and Biomanufacturing to Benefit Canadians
Funding will move novel cancer technologies from the lab to the clinic
OTTAWA, ON, Sept. 22, 2020 /CNW/ -BioCanRx, Canada's Immunotherapy Network, today announced funding of $10M for 14 cancer immunotherapy research projects and eight core and biomanufacturing facilities. In addition to BioCanRx's investment, matching partner contributions of $16.5M increase the total investment in Canadian translational cancer immunotherapy research and manufacturing facilities to $26.5M.
Cancer is one of the biggest health challenges facing Canadians. Nearly 1 in 2 Canadians is expected to develop cancer in their lifetime. BioCanRx is working to turn the tide and improve outcomes for patients by accelerating the development of promising immunotherapy treatments which could be more effective, affordable and safe than conventional cancer therapies.
"We're collaborating and building teams across Canada to find new ways for the body's immune system to outsmart and kill cancer. This new funding is helping to bridge the research gap between lab discoveries and clinical trials to ultimately benefit patients," said Dr. John Bell, BioCanRx's Scientific Director and a senior cancer research scientist at The Ottawa Hospital and the University of Ottawa.
BioCanRx's investments in the development of novel therapies continue to be guided and benchmarked by its Research Management Committee composed of internationally renowned academics and industry leaders in the field of cancer immunotherapy. The focus of the newly funded projects includes highly innovative and novel approaches to cancer treatment, targeting difficult to treat cancers where current options are limited. The project investment portfolio includes cross-disciplinary teams from across the country working on new, rational combination approaches and unique cell, vaccine/virus-based and antibody immunotherapies. Investments in Canada's biomanufacturing capacity also feature prominently and additional sites across the country will be added to our point-of-care cell manufacturing network to enhance access to life-saving therapies to patients across the country.
BioCanRx, a Government of Canada Network of Centres of Excellence, has been renewed for a 3-year cycle. In its first cycle of five years, BioCanRx invested $18.5M in Canadian immunotherapy research including eight "first-in-human" clinical trials. BioCanRx leveraged $62M in partnered funds and established core and biomanufacturing facilities to accelerate the pace of moving science discoveries out of the lab and into the clinic. A key investment enabled the building of Canadian capacity for point-of-care CAR T cell manufacturing. BioCanRx also formed the Cancer Stakeholder Alliance, made up of 51 cancer charities and non-government organizations, to help integrate the "patient voice" into all aspects of its clinical and science program and provide guidance with respect to health policy investments.
Additional Quotes:
Ken Newport, Chair, Board of Directors, BioCanRx:
"BioCanRx is investing in the best Canadian innovations in the field, always looking for a clear path to the clinic for the benefit of patients. It's also key to invest in the next generation of researchers. That's why we're committed to training and helping to build capacity in Canada for a thriving health biotechnology sector."
Dr. Stéphanie Michaud, President & CEO, BioCanRx:
"Working with our partners in industry, patient groups, not for profits and government organizations, BioCanRx is translating immune-based technologies from the lab into early phase clinical trials. We're also committed to working in parallel to address the socio-economic factors necessary for their adoption in the Canadian healthcare system."
Dr. Duncan Stewart, Executive Vice-President, Research, The Ottawa Hospital, CEO and Scientific Director, Ottawa Hospital Research Institute and Professor, University of Ottawa
"The Ottawa Hospital Research Institute is proud to host the BioCanRx network. Working together, we are providing crucial support for groundbreaking cancer immunotherapy research that could save and transform lives."
BioCanRx, Canada's Immunotherapy Network, is a network of scientists, clinicians, cancer stakeholders, academic institutions, NGOs and industry partners working together to accelerate the development of leading-edge immune oncology therapies for the benefit of patients. Our vision is to cure patients and enhance the quality of life of those living with cancer. BioCanRx invests in leading edge immune oncology research translating world-class technologies from the lab into early phase clinical trials. BioCanRx provides researchers with access to funding, expertise, training and manufacturing facilities and is a leader in the translation, manufacture and adoption of cancer immunotherapies. The network is committed to training and developing the talent needed for a thriving health biotechnology sector in Canada. BioCanRx receives funding from the federal government's Networks of Centres of Excellence, and support from industry, the provinces and charities. The network is hosted by the Ottawa Hospital Research Institute.
GOODLIFE LAUNCHES EXCLUSIVE PARTNERSHIP WITH REGYMEN FITNESS
GoodLife invests in the health of Canadians with next-level group fitness ‘experience’
[London, ON] — GoodLife Fitness, Canada’s largest fitness chain, has teamed up with Louisiana-based REGYMEN Fitness to offer members a revolutionary small-group workout with a high-energy, social atmosphere and fresh daily programming.
The partnership allows GoodLife to become the sole distributor of REGYMEN’s cutting-edge programming in Canada.
“Securing the exclusive rights to bring REGYMEN to Canada really amplifies GoodLife’s offering. We can now deliver a studio experience, with science-based, high-intensity workouts, alongside all the services and amenities of our current GoodLife clubs,” said David ‘Patch’ Patchell-Evans, founder and CEO of GoodLife Fitness. “We’re investing to bring more world-class fitness programming to Canadians at a time when we all need new options to be physically active.”
Launched in Baton Rouge, Louisiana, in 2018, REGYMEN combines interactive play and unparalleled program variety with its three unique workout streams – BURN, BOX and BUILD. The multi-platform approach offers ever-evolving sessions to maintain variety and prevent member plateauing.
BURN is a science-backed HIIT workout that incorporates cardio stations like the treadmill, ski erg, and assault bike along with kettlebells, TRX, dumbbells, core exercises, and stabilization movements to provide an incredibly effective 60-minute workout experience.
BOX* is a hybrid cardio and strength training session with heavy bag training, where Members will punch, knee, elbow, lift and box their way to an elevated heart rate and powerful workout.
BUILD includes Olympic barbells, bumper plates, battle ropes, and more to create a workout centered around increasing lean body mass while improving strength, flexibility, and technique.
Each REGYMEN class incorporates a high-energy atmosphere that encourages social interaction and creates a healthy, supportive team environment. The ever-changing programming comes in 30, 60 and 90-minute variations, providing highly efficient workouts for all fitness levels while accommodating busy schedules. Fitness tracking technology allows for individualized training experiences, while also promoting healthy competition among participants.
Dan McDonogh, director of programming and performance with GoodLife Fitness, said at a time when the fitness industry is feeling the effects of the pandemic lockdown, GoodLife is investing to expand its programming.
“Right now, it’s more important than ever that we expand our offering and give Canadians something to get excited about. REGYMEN has been hugely successful in the US since it launched, and many of our members have been waiting for us to bring it to Canada,” McDonogh said. “With endless combinations of functional programming, state of the art technology, rock star instructors, and unique studio design with audiovisual effects and specialty lighting, REGYMEN delivers an exclusive group fitness experience that drives results and will keep people coming back for more. Our members certainly deserve it.”
REGYMEN studios will be built within new and existing GoodLife Clubs and will offer their own schedule of workouts exclusively to GoodLife members who have purchased Performance memberships or the REGYMEN add-on. Single and multi-use passes can also be purchased. Performance memberships begin at $49.99 biweekly.
GoodLife built its first two REGYMEN studios during the pandemic’s peak shutdown period, meaning they are designed and operated according to The GoodLife Standard, a comprehensive health and safety plan focused on ensuring physical distancing, reducing capacity levels in our Clubs, and enhanced cleaning and sanitization practices.
The first-ever REGYMEN studio offered by GoodLife Fitness will open Monday, September 28, at GoodLife’s brand new 60,000-square foot location in Oakville. The launch at Oakville Place will be followed up with the opening of a studio at GoodLife Windsor Dougall & Cabana. GoodLife plans to open REGYMEN studios in Ottawa, Winnipeg, Calgary, and Toronto.
“All our programs have camaraderie in common: we’re focused on bringing people together in the spirit of social fitness. We’ve found a way to fuse technology with workouts backed by science in a welcoming, social atmosphere where the trainers go above and beyond, said EK Navan, co-founder of REGYMEN Fitness. “Not only are you going to have a blast with our gaming approach, you’re going to love our creative programming and ever-changing workout options that give you room to grow. REGYMEN combines interactive play and unparalleled program variety to drive member success to a new level, all in less than one hour.”
The master franchise rights agreement is a first-of-its-kind for REGYMEN, although the company previously launched studios within larger fitness clubs alongside their standalone offerings in the United States.
About GoodLife Fitness
Proudly Canadian since 1979, GoodLife is the largest group of fitness club chains in Canada and the fourth largest overall in the world. With almost 400 Clubs from coast-to-coast, over 11,000 employees and more than 1.5 million members, GoodLife is helping to transform the health and fitness of 1 in 25 Canadians every day. The GoodLife group of clubs includes GoodLife Fitness, Fit4Less, ÉconoFitness, and Oxygen Yoga & Fitness. www.goodlifefitness.com
About REGYMEN Fitness
REGYMEN Fitness is a high-energy, boutique fitness studio with three platforms: Burn, focusing on cardio and weights; Box, focusing on power punching and core work; and Build, focusing on compound movements and explosive cardio. Classes track heart rate and use analytics to help members set goals while giving them real-time access to the progress of their workout. It was created by fitness industry experts Edward Navan, Troy Archer and Donnie Jarreau in 2015 and launched franchising opportunities in 2018. To learn more about franchising opportunities, visit https://regymenfitnessfranchise.com/.
*The BOX program will initially remain off the REGYMEN schedule. GoodLife will introduce the BOX part of the REGYMEN workout when it is approved under regional and provincial public health regulations.
Holistic, Science-Backed Program Helps Build a Healthier Relationship with Food, Eating and Weight
San Francisco, CA, Sept. 22, 2020 — Could a dietary lifestyle that nourishes us physically, emotionally, spiritually and socially be the answer to stemming America’s rising tide of overeating and obesity?
Original research points to yes, and in Whole Person Integrative Eating: A Breakthrough Dietary Lifestyle to Treat the Root Causes of Overeating, Overweight, and Obesity, nutrition researcher Deborah Kesten, M.P.H., and behavioral scientist Larry Scherwitz, Ph.D., offer documented proof that by nourishing ourselves multi-dimensionally each time we eat, we can develop deeper, healthier relationships with food and eating that leads to attaining and maintaining weight loss. The authors’ Whole Person Integrative Eating (WPIE) program is not a diet that a person goes on … then off. WPIE is a scientifically sound, dietary lifestyle designed to be practiced for a lifetime.
"If people follow the revolutionary program outlined in this game-changing, insightful book, it may be the most helpful step they can take toward losing weight and keeping it off," says bestselling author Kenneth Pelletier, M.D., clinical professor of medicine at University of California School of Medicine, San Francisco.
Divided into three parts, Whole Person Integrative Eating begins by describing seven root causes of overeating: Emotional Eating, Food Fretting, Fast Foodism, Sensory Disregard, Task Snacking, Unappetizing Atmosphere and Solo Dining. A Self-Assessment Quiz follows, with 76 questions to help readers identify their unique food choices and eating behaviors that lead to overeating and weight gain. Part Two provides a step-by-step guide to WPIE antidotes for each overeating style. It also explains why the elements of WPIE work and how they can be incorporated into daily life. And Part Three offers over 30 recipes based on the three main criteria of WPIE: fresh, whole and "inverse,” meaning mostly plant-based foods with small or no servings of animal-based foods.
An excerpt from the Foreword of Whole Person Integrative Eating by New York Times best-selling author Dean Ornish, M.D., Clinical Professor of Medicine, University of California:
“[The book] offers an evidence-based alternative to the conventional wisdom about attaining and maintaining weight loss. What’s groundbreaking about Kesten and Scherwitz’s research is twofold: They have created a scientifically sound, comprehensive, and integrative program for treating overeating, overweight, and obesity based on these principles. And in addition to what (food choices) and how(eating behaviors) we eat, they have identified seven statistically significant root reasons to explain why we overeat: what they call “new normal overeating styles” and eating behaviors that also have a profound influence on how much we eat and weigh.”
The authors’ paradigm-shifting message is that food influences not only the physical dimensions of health, but also our emotional, spiritual and social well-being. Their dietary lifestyle can build bridges between the millions who struggle with overeating and weight issues and the medical community. And it can inspire us all to re-envision our relationships with food, eating and weight, so that each time we eat, we are nourished … for life.
Deborah Kesten, MPH,is an international nutrition researcher, award-winning author, and medical/health writer, with a specialty in preventing and reversing obesity and heart disease. She served as Nutritionist on Dean Ornish, M.D.’s first clinical trial for reversing heart disease through lifestyle changes, the results of which were published in the Journal of the American Medical Association. She has served as Director of Nutrition at cardiovascular clinics in Europe and on the Board of Directors of the American Heart Association, San Francisco, for 10 years.
Kesten has published more than 400 nutrition and health articles. Her first book, Feeding the Body, Nourishing the Soul, received the first-place gold award in the Spirituality category from the Independent Publisher Book Awards. Whole Person Integrative Eating has been honored with the #1 gold, best-book award in the Health category by Book Excellence Awards. She is a VIP Contributor at Arianna Huffington’s Thrive Global, and is married to behavioral scientist and co-author of Whole Person Integrative Eating, Larry Scherwitz, Ph.D.
LITTLE ACT. FOREVER IMPACT. AG HAIR INTRODUCES HEALTHY HAND SOAP AND LOTION
Vancouver-based hair care company expands new body care line with antimicrobial hand soap and lotion
Vancouver, B.C. (September 22, 2020): AG Hair is proud to extend its Body Care Collection to include new Healthy Hand Soap and Lotion. The Body Care Collection launched this past spring when the company pivoted to formulate Hands Free Sanitizer Gel and Spray to help fill an urgent demand. AG’s Body Care Collection is designed to provide universal utility — using the highest quality ingredients to create clean solutions for every body. With this most recent launch, AG’s focus remains on hands, understanding that keeping them clean and hydrated is vital to personal health and navigating this new normal as safely as possible.
Knowing that frequent hand washing is the most effective way to remove germs and bacteria, AG sought to develop a hand wash that people not only trust but genuinely enjoy using. Healthy Hand Soap ($9.99 / 12 oz) is formulated with benzalkonium chloride and antimicrobial essential oils that help reduce bacteria on the skin while aloe vera and cucumber extracts add essential hydration to keep hands feeling smooth. Dry or cracked hands can attract germs and bacteria and risk getting infected. To help keep them smooth, soft and safe, AG is launching Healthy Hand Lotion ($12.99 / 3 oz) to use after handwashing or sanitizing. Nourishing shea butter is combined with hydrating hyaluronic acid, moisturizing Argan and Abyssinian oils and infused with soothing aloe and cucumber extracts. In addition, this light and naturally fragranced hand lotion is antimicrobial adding even more protection.
“The extension of our Body Care line was a natural progression for us,” says Graham Fraser, CEO of Vancouver-based AG Hair. “When we shifted our production to focus primarily on hand sanitizer in March, we realized we could provide much more in body care. We hope Healthy Hands Soap and Lotion gives customers a sense of security knowing that they can continue to stay safe through consistent handwashing, while not at the expense of damaging and drying out their skin.”Committed to helping the community, AG Hair created a custom hand lotion in a 2oz tube to thank essential workers of the Provincial Health Services Authority in British Columbia (PHSA). 20,000 Healthy Hand Lotions (not for resale) will be donated to PHSA employees throughout British Columbia. The physical act of cheering every evening may have faded in recent months, but AG wants health care workers to know how that it’s always 7 p.m. in their hearts. Healthy Hand Soap 12 oz, Healthy Hand Lotion 3 oz and a travel-sized Hands Free Sanitizer Gel 2 oz will be available on aghair.com the week of October 26 and will launch shortly thereafter on Amazon.
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About AG Hair Known for their meticulous selection of natural ingredients, AG creates a new standard of beauty through handcrafted products that deliver on their promise. Founded in 1989 in Vancouver, Canada by John and Lotte Davis, AG has become a name synonymous with integrity and a brand whose devotees can't help but 'Use. Love. Repeat.' Since 2017, AG Hair has been a Canada’s Best Managed Companies winner, becoming a Gold Standard winner in 2020. A portion of every bottle sold supports One Girl Can, a registered charity that provides educational opportunities to girls living in Kenya. Aghair.com
Don’t Lose Focus on Vision Health During COVID: Glaucoma Expert Shares His Tips for Healthy Eyes
New York, NY, September 22, 2020 — The COVID-19 pandemic may have changed the way we visit our doctors, but it shouldn’t prevent us from staying up-to-date with our usual health care appointments, including vision checkups.
“During the coronavirus pandemic, people should guard their eyes with glasses or face shields to protect their eyes from virus infection," says Dr. Daniel Laroche, Director of Glaucoma Services and President of Advanced Eyecare of New York. People also need to know, even though there are many concerns about COVID-19, common-sense precautions can significantly reduce the risk of infection, he says, adding:“Wash hands frequently, follow good contact lens hygiene and avoid rubbing or touching our mouth, nose and especially our eyes.'' Dr. Laroche is also affiliated with the New York Eye and Ear Infirmary of Mount Sinai, Island Eye Surgical Center and New York University.
The COVID-19 pandemic has also changed the way people visit their doctors. For patients over 60, Dr. Laroche advises it's better to stay home and do telehealth over the phone or video consultation until the pandemic flattens. He also encourages people to wear face masks on visits and maintain social distancing, even if they are in a health clinic.
“Eyesight or human vision is one of the most important senses. As much as 80 percent of what we feel comes through our sense of sight. By protecting the eyes, people will reduce the chance of blindness and vision loss while also staying on top of any developing eye diseases, such as glaucoma and cataracts. A healthy brain function requires a healthy vision. The brain is our most essential organ, and it allows us to control other organs. Normal and healthy vision contributes to improved learning and comprehension for a better quality of life,” says Dr. Laroche.
Dr. Laroche says there is another critical issue that COVID-19 has brought to the forefront and that is the issue of health care disparities among Black and Brown people. “Nationally, African American deaths from COVID-19 are nearly two times greater than would be expected based on their share of the population. In four states, the rate is three or more times greater. In 42 states, plus Washington, D.C., Hispanics make up a greater share of confirmed cases than their share of the population. In eight states it’s more than four times greater,” he says, adding: “In stark contrast, white deaths from COVID-19 are lower than their share of the population in 37 states.”
Dr. Laroche says there are several things that can be done to not only address but to help combat this issue:
1. Increase the number of Black and Afro-Latino physicians worldwide.
2. Implement universal health care.
3. Increase wealth and education which produces better health.
4. Provide a living income stipend for poor people to access food and reduce malnutrition.
5. Eliminate racism to reduce stress.
6. Identify white supremist organizations as terrorist groups.
7. Recommend all corporations have people of color in the top management and leadership positions.
8. Eliminate sole reliance on standardized testing as the criteria to be used at entry to magnet schools.
9. Provide more funding to reduce homelessness and for mental health.
10. The government should also require medical school, research and hospital funding to diversify and benefit people of color.
About Dr. Daniel Laroche
Dr. Laroche is an exceptional glaucoma specialist in New York. He studied and received his bachelor's degree from New York University and a medical doctorate with honors in research from Weil Cornell University Medical College. He underwent a medical internship at Montefiore Hospital and finished his ophthalmology residency at Howard University Hospital in Washington D.C., where he was the chief resident in his third year. He later completed his glaucoma fellowship at New York Eye and Ear.
For more information about Dr. Laroche, please call 212-663-0473 or visit: www.advancedeyecareny.com.
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Sanofi and GSK sign agreements with the Government of Canada to supply up to 72 million doses of adjuvanted COVID-19 vaccine
Signed agreements relate to vaccine candidate using Sanofi's recombinant protein-based technology combined with GSK's pandemic adjuvant
Both companies are committed to making their COVID-19 vaccine affordable and available globally
TORONTO, Sept. 22, 2020 /CNW/ - Today, Sanofi and GSK announce the signing of agreements with the Government of Canada for the supply of up to 72 million doses of an adjuvanted COVID-19 vaccine, beginning in 2021.
"This announcement showcases our unwavering commitment to develop a COVID-19 vaccine that is available to everyone when it comes to market," said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. "To address a global health crisis of this magnitude, it takes partnerships and we are grateful to Canada for its collaboration, and to GSK for partnering with us to develop a safe and effective vaccine."
Roger Connor, President of GSK Vaccines added, "GSK is proud to be working in partnership with Sanofi to make this vaccine available as soon as possible in Canada. Both companies have significant R&D and manufacturing capability worldwide and are already working hard to scale up production. This announcement from the Government of Canada supports our ongoing efforts."
Both companies' global manufacturing networks will play a pivotal role in the production of the COVID-19 vaccine for Canada. Additionally, Research and Development at Sanofi's Toronto vaccine manufacturing site will play a role in process and analytical development along with clinical manufacturing to support Sanofi Pasteur's overall global efforts to develop and manufacture a vaccine that protects against COVID-19.
"Sanofi has a long-standing legacy of developing safe and effective vaccines for Canadians," remarks Jean-Pierre Baylet, General Manager, Sanofi Pasteur Canada. "The partnership with the Government of Canada marks a key milestone in protecting and serving the Canadian population against COVID-19 and builds on our Toronto manufacturing site's more than 100-year history as a reliable public health partner."
Sanofi is leading the clinical development and registration of the COVID-19 vaccine, and a Phase 1/ 2 study was initiated on September 3 with a total of 440 subjects being enrolled. The companies anticipate results in early December 2020 to support the initiation of a pivotal Phase 3 study before the end of the year. If the data is sufficient for regulatory application, it is planned to request regulatory approval in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant respectively with the target of producing up to one billion doses in total per year, globally.
On the front lines in the fight against COVID-19
Sanofi is also developing a messenger RNA vaccine candidate in partnership with Translate Bio. This is in addition to continuing to develop, manufacture and supply a broad portfolio of life-saving vaccines and to ensure that patients have continued access to our medicines. More information about Sanofi's response to COVID-19 can be found here.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally. For further information, please visit www.gsk.com
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
SOURCE Sanofi Canada
Experience the Freedom of Radical Self-Acceptance with Transformative Healing Method
Boston, MA, September 22, 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 Times, Shape 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.
DECN ANNOUNCES COMPLETION OF CRITICAL INSTRUCTIONAL VIDEOS FOR ITS GENVIRO! SALIVA SWIFT KIT FOR USA AND INTERNATIONAL PROFESSIONAL USE
visuals will accompany distribution of company’s GenViro! Swift Kits globally and also be posted on the web site in english, and with sub-titles in german, russian, spanish and french
LOS ANGELES, CA—September 22, 2020 / Decision Diagnostics Corp. (OTC: DECN) www.decisiondiagnostics.co, a leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters through its subsidiary Pharma Tech Solutions, Inc., today announced it has completed the two professional use instructional videos that will accompany the Genviro! Covid-19 Saliva Swift Kit to market both in the US and internationally. The videos provide step-by-step instructions for professionals to follow to obtain the most accurate results with each and every use of the product. As stated in a prior press release, the international product launch for GenViro! Swift will commence on September 26, 2020, and is expected to be rolled out over several weeks with pricing having been recently announced.
“Achieving accurate results using the Genviro! Swift Kits among professionals and eventually with at-home users will rely heavily on the ability to properly administer the test. That’s why we spent significant time and effort on the production and final video product to create what we believe are straightforward and easy to follow instructions. Instructional videos are a part of both the FDA EUA and CE Mark Iso emergency processes. There will actually be 6 total videos. Two in English, one each for the domestic and international product versions, and then with sub-titles added, one each in German, Russian, Spanish and French,” said CEO Keith Berman.
As stated in a prior announcement, the Genviro! Covid-19 Saliva Swift Kits had already completed a rigorous round of testing at the company’s manufacturing and product development facility in Daegu, Korea.
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. is the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters. DECN's products are designed to operate efficiently and less expensively on certain glucose meters already in use by almost 7.5 million diabetics worldwide. With newly inspired technology diabetic test strips already in the final stages of development, DECN products compete on a worldwide scale with legacy manufacturers currently selling to 71+ percent of a $15+ billion at-home testing market. The company's new GenViro!™ product designed to test for Covid-19, is not yet available in the United States or Puerto Rico, but Emergency (EUA) Waivers are in process with the U.S. FDA. On September 26, 2020 the company plans to launch its International package versions of its GenViro! Swift Kit and Swift Meter.
Forward-Looking Statements:
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of September 21, 2020, regarding the company's business and performance, its prospects, current factors, the economy, and other future conditions and forecasts of future events, circumstances, and results.
Knowing that frequent hand washing is the most effective way to remove germs and bacteria, AG sought to develop a hand wash that people not only trust but genuinely enjoy using. Healthy Hand Soap ($9.99 / 12 oz) is formulated with benzalkonium chloride and antimicrobial essential oils that help reduce bacteria on the skin while aloe vera and cucumber extracts add essential hydration to keep hands feeling smooth. Dry or cracked hands can attract germs and bacteria and risk getting infected. To help keep them smooth, soft and safe, AG is launching Healthy Hand Lotion ($12.99 / 3 oz) to use after handwashing or sanitizing. Nourishing shea butter is combined with hydrating hyaluronic acid, moisturizing Argan and Abyssinian oils and infused with soothing aloe and cucumber extracts. In addition, this light and naturally fragranced hand lotion is antimicrobial adding even more protection. 
“The extension of our Body Care line was a natural progression for us,” says Graham Fraser, CEO of Vancouver-based AG Hair. “When we shifted our production to focus primarily on hand sanitizer in March, we realized we could provide much more in body care. We hope Healthy Hands Soap and Lotion gives customers a sense of security knowing that they can continue to stay safe through consistent handwashing, while not at the expense of damaging and drying out their skin.”Committed to helping the community, AG Hair created a custom hand lotion in a 2oz tube to thank essential workers of the Provincial Health Services Authority in British Columbia (PHSA). 20,000 Healthy Hand Lotions (not for resale) will be donated to PHSA employees throughout British Columbia. The physical act of cheering every evening may have faded in recent months, but AG wants health care workers to know how that it’s always 7 p.m. in their hearts. Healthy Hand Soap 12 oz, Healthy Hand Lotion 3 oz and a travel-sized Hands Free Sanitizer Gel 2 oz will be available on 
