New Trial Data: Senzer's Inhaler Delivers Cannabinoids Faster at Lower Doses
LONDON, Sept. 25, 2018 /CNW/ - The physical uptake of pharmaceutical cannabinoids when inhaled through Senzer's unique respiratory device is more than 50 times faster than oral delivery, at just a fraction of the dose, according to data released today under a clinical trial conducted in the US.
Senzer, a UK-based drug delivery company, reported the success of a 36-subject pharmacokinetic trial conducted in the US by its partner, Insys Therapeutics, Inc. a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology. Insys holds the license to use Senzer's device to deliver the cannabinoid, Dronabinol, in the US and the trial is part of its goal to achieve regulatory approval from the U.S. Food and Drug Administration. Senzer's patented device allows conversion of cannabinoids into very small particle sizes, and other research by the Company has shown that this allows delivery of actives deep into the lung, into the smaller distal passageways. Unlike other respiratory approaches, such as nebulizers or mainstream inhalers, Senzer's offering can result in a much more rapid uptake of the drug, comparable to injectables or IVs.
"These positive results generated by Insys show how our device can deliver cannabinoids faster and in much smaller doses, which should be of great benefit for both patients and health professionals," Senzer CEO Alex Hearn said. "Our approach is unique in this exciting sector, and offers a simple and minimally invasive way to ensure much more effective delivery of pharmaceutical-grade cannabinoids."
Insys reported the study enrolled 36 subjects and compared a single 0.35 mg dose of inhaled dronabinol to a single 5.0 mg dose of oral dronabinol (Marinol capsule). The findings indicated that inhaled dronabinol, even at just 7% of the oral dose, had a much faster absorption rate. The difference in Tmax-–the time to peak concentration (Cmax) of drug in blood plasma-–was over 50 times faster with the test product: 2 minutes with the inhaled dronabinol, compared to 1.53 hours with the oral dronabinol. In addition, Cmax with both formulations was similar, despite the considerable difference in doses, Insys reported.
"This pharmacokinetic study provides evidence of our unique drug-device combination's viability as a mechanism to deliver dronabinol into the distal lung for rapid systemic absorption," said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics. "Its completion represents the next step in our clinical development program for dronabinol inhalation as an investigational product concept, which has future potential in the treatment of a variety of conditions, including anorexia in cancer."
About SENZER
SENZER Ltd. is a U.K.-based inhalation technology company specializing in the development and commercialization of therapeutic delivery systems of cannabinoid products, and it is developing a pipeline of inhalation and delivery products to meet unmet medical needs. Senzer's platform is based around a patented device that allows swift and effective inhaled delivery of cannabinoids, as well as other active pharmaceuticals.
About INSYS
INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients' quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating anaphylaxis, epilepsy, Prader-Willi syndrome, opioid addiction and overdose, and other disease areas with a significant unmet need.
SOURCE Senzer Limited
Reclaim your skin with Dermakalm specialty skincare line
TORONTO, Sept. 25, 2018 /CNW/ - November is eczema awareness month. Also known as dermatitis, eczema is a chronic inflammatory skin condition characterized by dry skin with very itchy red patches that may ooze, become scaly, crusted or hardened. Eczema can affect any part of the body and anywhere from 10 to 20% of the Canadian population is affected.
Although genetic, immunological and environmental factors play a key role, the specific cause of eczema is not known. While no cure has yet to be found for eczema, and no treatment successfully works for everyone, there are ways to manage eczema to make it more tolerable including: frequent bathing and moisturizer application, as well as the use of over-the-counter (OTC) creams designed for eczema such as Dermakalm.
Dermakalm Eczema Creams are non-greasy, specialized formulations containing aluminum silicate which help provide temporary relief of symptoms of atopic eczema and hand and contact eczema.
Unlike other eczema product offerings, Dermakalm is free of corticosteroids, fragrance, parabens and artificial colouring. Dermakalm helps activate the skin's own repair mechanism through the combination of moisturizing lipids and a mineral complex.
Developed with dermatologists, Dermakalm Eczema Creams are available OTC in adult and infant/children (eight weeks and older) formulations for atopic eczema and in adult formulations for hand and contact eczema.
- Dermakalm Eczema Cream (Face and Body)
- Dermakalm Eczema Cream for Infants and Children (Face and Body, eight weeks+ years old)
- Dermakalm Hand and Contact Eczema Cream
If you've experienced it yourself, you know how frustrating it can be dealing with eczema. Skin ailments can adversely affect an individual's mental well-being and severely influence their personal, professional and social life. Common psychological problems associated with skin issues include feelings of stress, anxiety, anger, depression, shame, social isolation, and low self-esteem.
Dermakalm can help break the cycle, allowing you to reclaim your skin.
To learn more, please visit dermakalm.com/eczema
SOURCE Paladin Labs Inc.
SE Health marks 110 years
MARKHAM, ON, Sept. 25, 2018 /CNW/ - This Canadian social enterprise is no stranger to change. Marking its 110th year this September, Saint Elizabeth – now known as SE Health – has been a driving force of health innovation and care since 1908. What started out as four visiting nurses in downtown Toronto has evolved into a mobile team of 9,000 health professionals bringing a full range of services to people and families in homes and neighbourhoods across Canada.
"The playground today is very different but the core inspiration for our work as a not-for-profit charity remains the same: Empower people with the knowledge and tools to live their best lives – and work with partners to build a stronger and more inclusive society," says Shirlee Sharkey, who has led SE Health as its CEO since 1992.
As corporate brands transform to become more purpose-led, organizations like SE Health must continue to evolve their skills and offerings to fill gaps and create value. It is this type of agile thinking that fuelled the launch of SE Global, an advisory services arm that is helping international health systems improve the patient experience, grow a quality talent pool and optimize operations. Earlier this year, SE Health formalized a new partnership with Royale Home Health to support knowledge transfer, capacity development and best practices in the Middle East.
Closer to home, SE Health works with governments, hospitals, regional health authorities, the seniors' living sector, and individuals and family caregivers to help Canadians live and age with health, vitality and dignity. This includes partnering with health systems to design and deliver specialized transition and reactivation programs that bridge care from hospital to home. Other partnerships include working with digital health companies like Fonemed to open the door to new possibilities in care.
With an aging population, the demand for smart services and high quality care in the home will only continue to increase. That bodes well for the future of SE Health, which has grown 144% in the past decade alone and operates both a standalone research centre and network of health career colleges to meet the knowledge and education needs of a rapidly-changing industry.
In the future, the way we live and die will be nothing like what it has been for the past century or more. To prepare the organization for its next 110 years, SE Health has established SE Futures, a core team of disruptors and designers that is guiding stakeholders towards a future that is more predictive, proactive, decentralized, continuous, people-powered and values-based.
Reflecting on the success and evolution of SE Health, Ms. Sharkey highlights the role of its culture and people: "They say in life, you get what you give. At SE Health and Elizz, we're about spreading hope and happiness and that's something that never gets old."
To learn more about the ways SE Health is dedicated to a brighter future of health care at home, view our 2018 Impact Report or explore our new website at sehc.com.
About SE Health
SE Health is a not-for-profit social enterprise applying knowledge, vision and drive to forever impact how people live and age at home, today and into the future. With Canadian roots and 110 years of expertise, the organization brings quality excellence and innovation to home care, seniors' lifestyle, and family caregiving. Through its team of 9,000 Leaders of Impact, SE Health delivers 20,000 care exchanges daily, totaling 50 million in the last decade alone. Visit us online at sehc.com.
SOURCE Saint Elizabeth Health Care
The Kindness Advantage: Cultivating Compassionate And Connected Children
By Dale Atkins, PhD and Amanda Salzhauer, MSW
Greenwich, CT, September 24, 2018 — Kindness leads to compassion and happiness, future success, better relationships, improved self-esteem, and good mental and physical health. And don't we all want that for our children, our families and our community? The Kindness Advantage: Cultivating Compassionate and Connected Children provides parents with a practical and concrete guide to equip their child with the skills they need to have a positive influence on the world. This book goes well beyond teaching "please” and "thank-you.” It will show parents how to help their child form compassionate habits that will last a lifetime.
The Kindness Advantage is written by mental health professionals Dale Atkins and Amanda Salzhauer. Both experts are available to speak on topics that affect children and families to emphasize how to tap into kindness when dealing with such issues as bullying, school shootings, child welfare, community service, and the intergenerational divide. The Kindness Advantage is for parents who see the need for more civil, respectful, and considerate behavior among children. Research shows that children who are raised in a culture where giving and compassion are valued become happier and more positively engaged with those around them. Some of the characteristics in deeply connected people are empathy, acceptance, and questioning. These and other characteristics are essential to being kind and charitable, and vital to living a purposeful life.
First, The Kindness Advantage helps parents recognize these qualities; next, it shares ways to nurture them in everyday life. Finally, it shows parents how to teach them to their children. In Part Three there are additional chapters to support these efforts, with conversation starters, strategies to help children relax, tips for troubleshooting challenging situations, along with recommendations for adults and children interested in learning more. There are also several blank pages at the end of the book for taking notes, writing questions, and keeping track of resources with the hope that this book with turn into the family's personal activity workbook. Each fundamental characteristic includes an introduction along with:
1) Text to be read and discussed with the child.
2) Questions to help children connect the concept with their own life experience.
3) Ideas and activities to weave that concept into everyday life.
4) Inspiring real-life stories about children who make a difference.
5) Quotes from children, clergy, and community leaders and others about the values of caring and compassion.
The Kindness Advantage is based on a simple yet powerful premise: that living a compassionate life, one in which kindness is highly valued, is the key to our children's current and future wellbeing. There are so many ways to create meaningful connections with others. The Kindness Advantage is designed to be used in whatever way works best for families, giving their children the advantage of kindness to last a lifetime.
About the Authors:
Dale V. Atkins, PhD, is a licensed psychologist with more than forty years of experience as a relationship expert focusing on families, wellness, managing stress, and living a balanced, meaningful life. Author of six books and many chapters, articles, and journals for popular and professional audiences, Dale is a featured speaker who leads seminars worldwide on raising financially responsible, and charitable children. Dale is a frequent guest expert in the media and appears regularly on NBC's TODAY and CNN. Dale has a private psychology practice in New York City. She has two children and six grandchildren, and lives in Connecticut. She can be found on Twitter (@DrDaleAtkins), Facebook, and at www.drdaleatkins.com.
Amanda R. Salzhauer, MSW, has worked as a social worker in clinics and private practice. She has been a member of several nonprofit boards, including Riverdale Neighborhood House and the Board of Overseers for the Dartmouth Center for Social Impact. She has three children and lives in New York City.
The Kindness Advantage: Cultivating Compassionate and Connected Children
By Dale Atkins, PhD and Amanda Salzhauer
Available wherever books are sold or to order from the publisher, contact: (800) 441-5560 or www.hcibooks.com
ISBN: 9780757320997
$15.95
Release date: September 2018
###
TIP SHEET:
Suggested Author Interview Questions:
1) Why kindness/What is the Kindness Advantage?
2) What were we seeing that made us want to write the book? Tell us about the journey of writing this book?
3) Talk about your relationship and family background?
4) How do you get kids to be charitable?
5) What are 3 everyday things you can do to help your child become kinder?
6) Why start so early? Where is the evidence for starting early?
7) How do you teach kindness?
8) Why is it important to be kind? Examples of what society looks like when people are not kind.
9) What do you do when your kid is not being kind?
Praise for The Kindness Advantage:
Dr Atkins and Ms. Salzhauer are keenly aware of how we as parents grow, learn and change. They support our deepest intention to support our children to thrive in the world by providing clear and actionable steps to build up this tremendously important capacity. Atkins and Salzhauer offer a map for parents and children to travel together, so that the same daily routine might add a detour or re-route to take the high road. Bravo to Dale Atkins and Amanda Salzhauer for focusing parents around a path to true fulfillment for our children. Enjoy sharing this adventure in kindness with your children!
Lisa Miller, PhD, author of The Spiritual Child; The New Science of Parenting for Health and Lifelong Thriving: "In this day and age, kindness and connection are especially important. An accessible and informative guide, The Kindness Advantage is a must read for parents of all ages.”
Judson Brewer MD PhD, author of The Craving Mind: From Cigarettes to Smartphones to Love – Why We Get Hooked and How We Can Break Bad Habits: "Dale Atkins and Amanda Salzhauer's book, The Kindness Advantage, can serve as a partial antidote to these turbulent times. They remind us that kindness is both a moral behavior that can improve the status of the world, but also be advantageous to the individual who practices kindness. The book's blend of significant and relevant issues in psychology, education, and humanism provides a myriad of practical suggestions to help us raise kind children. The book will serve as a resource to parents and educators. By teaching the components underlying kindness children can be provided a framework where we can both teach and weave these crucial lessons into the lives of children.
The section on relaxation, breathing, visualization and mediation is a gift to the children in our lives and ourselves. We cannot impart the lessons of kindness when we ourselves are agitated and distressed by the tumult in our lives and in our worlds. Likewise, children have difficulty being kind when they are in the grip of negative emotions. This section provides children and adults the tools to master negative emotions. We highly recommend this book to be read, saved and used as a long term resource in your child rearing library.”
Norma D. Feshbach, Ph.D. Professor, Chair, Interim Dean Emeritus UCLA, and
Laura E. Feshbach, Ph.D. in Child Clinical Psychology from University of Washington: "The Kindness Advantage is the perfect book. Building on scientific evidence about developing aspects of kindness, such as empathy, it gives clear, practical advice to parents and suggests engaging activities and stories for children. Nothing could be more important today than increasing compassion and decreasing polarization and acrimony. I am going to give this book to my son who has a young daughter.”
Dr. Susan Fuhrman, Ph.D., President Emerita, Teachers College Columbia University: "In times of discord and polarization, kindness is a family value that can often be overlooked and underestimated. But, in truth, few parental responsibilities carry more weight -- and bring more joy -- than teaching children the power of flexing their own kindness muscles. Steeped in research and brimming with practical tips, The Kindness Advantage provides parents with a blueprint for nurturing empathy in young children, while offering real-life stories that both instruct and inspire. This is a thoughtful guidebook for parents, caregivers, and any adults looking to help build happiness, raise good citizens, and create harmonious communities."
Myung Lee, Executive Director of Fund for Cities of Service: "The Kindness Advantage … is exactly what we need more of right now. With empowering examples and science-based truths, Dale and Amanda share what it takes to foster kindness, empathy, compassion, and heart in our families. Parents will learn how to take on social questions and connect in a way that will improve the lives of their children and help create a more nurturing world. Highly recommended!”
Amy McCready, Author and Founder, Positive Parenting Solutions: "This enormously insightful book provides an inspiring and fundamental blueprint on how kindness can and should be taught to children. It provides essential ways to have conversations with your children on how to be kind. The Kindness Advantage reinforces how considerate and kind behavior can be life-changing and life lasting for children to help make the world a better place.”
Laura Schroff, #1 New York Times and internationally bestselling author of An Invisible Thread:
"The Kindness Advantage is the ray of hope that we all need in this harsh, heavy, world. It is a blueprint of how to partner with the next generation to live our inherent values, to tap our organic ability to love, and to create a kinder culture. Many thanks to Dale Atkins and Amanda Salzhauer for bringing this much-needed gift to the world!”
Rev. Susan Sparks, Pastor, Comedian, and Author of Laugh Your Way to Grace: "As a physician who uses mindfulness practices extensively in working with patients, health care professionals, and people dealing with all varieties of stress, I love that this book incorporates those practices into a guide for parents who are teaching their children to be kind. The authors wisely lead with the evidence that kindness leads to greater happiness, meaning, and wellbeing, and then provide a myriad of inspirational examples and ideas for children and parents. Grandparents, who are often crucial inspirational figures in children's lives, may particularly benefit from ideas for intergenerational collaborations in kindness.”
Patricia A. Bloom, M.D., Certified Teacher of Mindfulness-Based Stress Reduction;
Clinical Associate Professor of Geriatrics, Mount Sinai Medical Center, New York, NY: "With optimism and compassion, The Kindness Advantage offers practical tips and real-world examples parents and educators need to teach empathy, compassion, and kindness to our children. Along the way, it also provides opportunities to reflect on our values and experiences as adults. This book speaks to the innate desire of every child to be good to themselves and those around them. Dale Atkins and Amanda Salzhauer make the case for kindness as the tool to radically transform our children's lives, and our own.”
Naila Bolus, President & CEO, Jumpstart: "Just like we see in kids who have the empathy advantage, children who are raised with the kindness advantage are happier, connected, compassionate, and will have what they need to become change makers in their world. The Kindness Advantage offers parents the tools to teach these skills and more to their young children. With the extensive examples of activities provided in the The Kindness Advantage, parents can pick and choose what resonates with them to create a personalized approach to bringing kindness into their everyday lives.”
Michele Borba, Ed.D., author of UnSelfie: Why Empathetic Kids Succeed in Our All-About-Me World: "It is through kindness that we find inner peace, and understanding of our humanity, our interconnectedness. Thank you Dale Atkins and Amanda Salzhauer for gifting us with The Kindness Advantage, a guide to share this most powerful and important tool with our children.”
Janet Slom, MFA, founder, Mindfulness-Based Self Expression: "The Kindness Advantage provides practical wisdom and good-sense guidance to help you scaffold your child's journey toward goodness of heart. This book is a gift which has arrived at the perfect time for our world.”
Amishi Jha, Ph.D., Neuroscientist and Researcher: "Before we expect kindness from others, we have to nurture it in ourselves. Thanks to The Kindness Advantage we now have the recipe to raise children that better the world not because of what they have done, but because of who they are. And, in the process, we can learn to become kinder people in an often divisive and complicated world.”
Loss Is A Four-Letter Word: A Bereavement Boot Camp for the Widowed
By Carole Brody Fleet
"Carole Brody Fleet is forthright in dealing with many of the difficult issues surrounding widowhood, demonstrating that you do not have to live in your past. It's not an either-or situation. She teaches the important lesson that you can incorporate your previous life into a new life.”
—Jane Brody, personal health columnist, The New York Times
Deerfield Beach, FL, September 24, 2018 — No widow or widower look exactly the same. No widowhood looks exactly the same. Therefore, no healing journey or timeline is an identical experience. The word "loss” contains only four letters, but its size belies the amount of fear it produces at even its mere mention. Even more terrifying and enormous is the reality of loss–specifically, the loss of a spouse.
Widowhood has the capacity to keep those affected from moving forward into a new and fulfilling life. The loss of a spouse is frightening. The call for relatable and actionable direction and advice remains a very real need for the widowed community, and that is just what Loss is a Four-Letter Word offers. Award-winning author Carole Brody Fleet personally experienced the pain and grief as a young widow and mother; leaving her and her 9-year-old daughter alone. Loss is a Four-Letter Word shows readers a way out, a way to move forward– not "get over”–their most profound loss in positive ways. Fleet combines no-nonsense, direct advice with specific, boot-camp style "assignments” that are framed with compassion and humor to help them through a most challenging life-journey.
A short sample of the Bereavement Boot Camp Lessons:
• Lesson One: I'm Still Here
• Lesson Two: "My Healing Journey Is Mine”
• Lesson Three: Stop Putting Off Proactivity
• Lesson Four: "I Turn to… Who?”
• Lesson Five: Put Your Tits on Your Back
• Lesson Six: Get Up, Get Moving… Get Out!
• Lesson Seven: It's Your Turn
• Lesson Eight: Past, Present, and Future: You Can Have All Three
Loss is a Four-Letter Word gives readers help without reproach, education without lecture, and support without judgment, condition, or negative opinion. All of which provides a necessary light during such devastating times. Fleet tells them, "Because while our spouses may have departed this earth, we are still here. And we matter too.”
About the Author:
Carole Brody Fleet is the award-winning author of When Bad Things Happen to Good Women, Happily EVEN After, and Widows Wear Stilettos. Widely recognized as America's go-to expert on life adversity and grief recovery, Ms. Fleet is also a three-time contributor to the iconic Chicken Soup for the Soul book series, as well as a regular contributor to The Huffington Post and to ThirdAge.com. Ms. Fleet is also a popular motivational speaker and with her inimitable message of "What Now and What Next?” Ms. Fleet offers practical, emotional, and even humorous guidance to the millions who have experienced any kind of loss or challenge in their lives.
Loss Is A Four-Letter Word: A Bereavement Boot Camp for the Widowed
By Carole Brody Fleet
ISBN: 9780757321214
September 2018
$15.95
Available wherever books are sold or to order directly from the publisher, contact:
(800) 441-5569 or www.hcibooks.com
###
Suggested Interview Questions:
1. Where did the title of the book come from?
2. How does Loss is a Four-Letter Word differ from all of the other "grief” books?
3. What inspired you to write Loss is a Four-Letter Word?
4. What inspired you to begin writing in the loss / grief recovery genre in the first place – after all, these are not the happiest subjects in the world.
5. This is the first time that any of your writings have included a discussion on spirituality in connection with grief recovery. Why did you decide to include a chapter on spirituality when you have shied away from it in the past?
6. What are some of the lessons and experiences that you felt were especially necessary to communicate in the book?
7. What are some of the most common problems and challenges that face the widowed and what are the best ways to move past those challenges?
8. You have received hundreds of thousands of letters over the years. If you had to pick just one thing, what would be the one most common problem that people write to you about?
9. One of your favorite subjects concerns some of the things that people say when trying to help or otherwise comfort someone coping with loss. Even though most likely mean no harm, what are some of the dumbest things that you know people have said?
10. What are some of the first steps to take at the beginning of a healing journey?
Reviews:
Karen Noé, author, We Consciousness: 33 Profound Truths for Inner and Outer Peace and Your Life After Their Death: A Medium's Guide to Healing After a Loss: "Carole Brody Fleet has done it again! In Loss is a Four Letter Word, she offers practical, straightforward advice on how to move forward on a positive path after losing a loved one. I've had Carole as a guest on the "Angel Quest” radio show a number of times because of how much she has benefited my listeners with her knowledge. If it sounds like I am impressed with her, it's because I am. I love this book, and I love Carole!”
Lisa Lockwood, crime analyst, author, police and military veteran: "What I love and appreciate is Carole Brody Fleet's firsthand knowledge and approach on the most taboo topic in society. Having gone through personal loss, I always learn something about how to approach the topic with empathy and how to permit others to comfort me in the worst of times.”
Stacey Gualandi, Emmy award-winning journalist: "Carole Brody Fleet has faced painful challenges and loss with courage and resilience. Through her own personal healing, we can all learn from and be inspired by her. I have a four-letter word for Carole: HERO.”
Kristin Higson-Hughes, Senior Features Editor, Women's World Magazine: "Just as there is no timetable to grief, there certainly is no checklist on how to recover strength and joy after suffering a loss. Here you will find authentic, candid, trustworthy, and--perhaps most pertinent of all--pragmatic advice promising that although the landscape of life may forever be changed, the future can still hold purpose, beauty, and magic. With a signature style all her own, Carole Brody Fleet "trains" you to find yourself again (hint: there's no wrong path, but some are healthier for your soul!). Together, you will navigate everything from social media to financial matters to the possibility of finding love again. Sure, it can feel impossible to do, and even more so to find answers, but sign up, dear recruit, and discover this book's wit and wisdom, and its author's enormous-as-the-universe heart!"
Kim Iversen, nationally syndicated radio show host: "Carole is an angel, not just an expert. Many of us have no clue what to say to a loved one going through tremendous loss. We sit by and watch helplessly as they struggle with their 'new normal'. Carole's book is a must read; not just for widows, but for those of us who love a widow as well. As a relationship radio talk show host, I have always had words to comfort and guide someone through every type of heartache-----every heartache except the death of a spouse. This type of loss leaves many of us speechless. Finally, someone who knows what to say when the rest of us do not."
PharmaMar Presents the Overall Survival Data From the Phase I/II Study of lurbinectedin in Combination With Doxorubicin for Relapsed Small Cell Lung Cancer
- The results are from Cohort B of the Phase I/II Study in patients with relapsed Small Cell Lung Cancer (SCLC). This study preceded the Phase III ATLANTIS study with the same doses and a similar population
- The poster has been presented at the World Congress of the International Association for the Study of Lung Cancer (IASLC 2018), in Toronto
- The data reveal an Overall Survival of 10.2 months in patients with SCLC and a chemotherapy free interval (CTFI) of 30 days or longer, reaching 11.5 months in platinum-sensitive patients
- Safety data, Overall Survival and also Progression Free Survival can be observed on the poster
MADRID, Sept. 24, 2018 /CNW/ - PharmaMar (MCE: PHM) has presented data during the International Association for the Study of Lung Cancer (IASLC 2018), that is taking place from the 23rd to the 26th of September in Toronto (Canada), on Overall Survival (OS) from the Phase I/II Study of lurbinectedin in combination with doxorubicin for relapsed small cell lung cancer.
(Logo: http://mma.prnewswire.com/media/624563/PharmaMar_Logo.jpg)
An OS of 10.2 months has been observed in the study for patients treated with lurbinectedin in combination with doxorubicin in patients with a CTFI of 30 days or longer, reaching 11.5 months in platinum-sensitive patients (CTFI- equal or better than 90 days).
We believe that the OS periods observed in this trial are more favorable than those seen in historical trials of the primary treatments used for second line in SCLC, such as topotecan or the CAV combination (cyclophosphamide, adriamycin, vincristine).
This Phase I/II multicenter, clinical study has analyzed the second line treatment of patients with SCLC, corresponding to cohort B (n=27), of the study, involving a doses of 2mg/m[2] of lurbinectedin + 40mg/m[2] of doxorubicin, the same doses and similar population to that being evaluated in the randomized Phase III ATLANTIS Study. In July 2018 this study reached its recruitment objective of 600 patients from 160 centers in 20 countries, and the results are expected at the end of 2019.
Dr. Martin Forster, MD, PhD, of the University College London Hospitals and UCL Cancer Institute, UK, has commented, "I have been involved in a wide number of trials with lurbinectedin for more than five years, both in studies as a single agent and in combination, and I think that it is a molecule with a novel mechanism of action and promising anti-cancer activity, which has exhibited acceptable safety profile both as a single agent and in combination. I consider lurbinectedin as an innovative molecule, which I think may have an important role to play in the treatment of patients with this particularly aggressive type of lung cancer, if approved."
Dr. Emiliano Calvo, MD, from the START Madrid-CIOCC Early Phase Clinical Drug Development program, at Hospital Madrid Norte Sanchinarro, Madrid, Spain, has affirmed that, "It is very necessary to have new alternatives for the treatment of this type of aggressive cancer. As we have been able to observe in the Overall Survival data, the combination of lurbinectedin plus doxorubicin appears to show a greater benefit than the current standard treatments, therefore, possibly providing a new therapeutic alternative for the patients that suffer this terrible illness." He adds, "Patients with small cell lung cancer need new therapeutic alternatives, and the results of this lurbinectedinstudy could help change the landscape of treatment in an environment where, unfortunately, important progress has not been made within the last 15-20 years."
Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.
About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several ty-pes of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical enterprise, Zelnova Zeltia.
To learn more about PharmaMar, please visit us at http://www.pharmamar.com.
About lurbinectedin
Lurbinectedin (PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.
Visit PharmaMar on:
Twitter
Facebook
LinkedIn
Instagram
YouTube
SOURCE PharmaMar
It’s Not Just About Snoring;
Sleep Apnea Can Prove Fatal
Many people may think sleep apnea is just an inconvenience for those who are afflicted with the condition. Others may think it is unfortunate for those forced to listen to their partner’s snoring.
But sleep apnea also can be lethal.
“A person can go for weeks without food, days without water, but only minutes without air,” says Dr. Daniel Klauer, DDS, author of Achieve Your Victory: Solutions for TMD and Sleep Apnea (www.drdanielklauer.com).
“Waking up gasping for air is more than an inconvenience; it can be life-threatening. People who have sleep apnea should not shrug it off as something minor.’’
Actress Carrie Fisher’s death was attributed – at least in part – to sleep apnea. Other celebrities with sleep apnea listed as a contributing factor in their deaths include actor John Candy, rock star Jerry Garcia and NFL player Reggie White.
Klauer says disturbances in sleep bring decreased levels of oxygen to the brain, which can lead to a host of health issues such as heart disease, hypertension and diabetes. A 15-year study of more than 10,000 adults, published in the Journal of the American College of Cardiology, also found strong links between sleep apnea and cardiovascular diseases.
Deaths from sleep apnea alone are not common, but sleep apnea elevates the risk of dying from other issues. People with untreated sleep apnea are more likely to have a heart attack; have a higher risk of having a stroke; and have three times the risk of a premature death. One study showed that 42 percent of the deaths in sleep apnea patients were due to heart disease.
Klauer says there are four signs someone could suffer from sleep apnea:
- Snoring. Approximately 35 percent of married couples sleep in separate bedrooms due to snoring. Snoring isn’t always a sign of sleep apnea, Klauer says, but it is typically one of the symptoms. If snoring is accompanied with choking or gagging sounds through the night, then the sleeper is experiencing sleep apnea.
- Patient stops breathing during sleep. Sleep apnea sufferers stop breathing 30 or more times an hour for a minimum of 10 seconds or more at a time. The interruptions in sleep lessen the oxygen flow to the brain, and the brain doesn’t function well on low oxygen.
- Day fatigue. Most victims of sleep apnea report feeling tired most of the time. And since a person with sleep apnea typically has shallow breathing or wakes up constantly, in addition to being tired during the daytime, they are also usually drowsy and irritable – which are symptoms of somebody who is simply not getting enough sleep.
- Teeth grinding. This is the condition known as bruxism. Sleep apnea sufferers may awake with sensitive teeth or tight jaw muscles, Klauer says. It happens because the breathing airway is obstructed. According to the National Sleep Foundation, one in four people with obstructive apnea grind their teeth.
“Too many people may think their partner’s snoring is just an inconvenience, so they move into the next bedroom and think the problem is solved,” says Klauer. “Many times, the person who suffers from sleep apnea just gets used to the snoring and waking in the middle of the night. So once their partner moves into another bedroom, they stop taking it seriously. But to ignore those symptoms and not talk to your doctor could be a fatal mistake.”
About Dr. Daniel Klauer, DDS
Dr. Daniel Klauer, DDS, is author of Achieve Your Victory: Solutions for TMD and Sleep Apnea (www.tmjsleepindiana.com). Since 2013, Dr. Klauer has limited his practice to treating patients with craniofacial pain, TMD, and sleep breathing disorders. Dr. Klauer is board certified with the American Board of Dental Sleep Medicine, American Board of Craniofacial Pain, and the American Board of Craniofacial Dental Sleep Medicine. He is diplomate eligible with the American Board of Orofacial Pain. He attended the University of Notre Dame and was a member of the Big East Championship Varsity Golf Team. After graduating from the University of Notre Dame, Dr. Klauer earned his doctor of dental surgery degree (DDS) from Ohio State University.
Namaste The Hard Way: A Daughter's Journey to Find Her Mother on the Yoga Mat By Sasha Brown-Worsham
"A moving, profound story about the love between mothers and daughter and what they share, even after death. You definitely don't have to have even stepped foot in a yoga studio to appreciate this story. It's the kind of book that stays with you long after you finish and make you want to hold the people you love even closer.” − Mandy Stadtmiller, Author of Unwifeable
"My mother used to chant in Sanskrit in her study before sunrise every morning. Though she died when I was 16—22 years ago—I always hear her voice that way. Off-key, but strangely hypnotic, the language both complicated and pure, reverberating around our house.”
– from Namaste the Hard Way
Deerfield Beach, FL, September 24, 2018 — While other moms were at Bible study, Sasha Brown-Worsham's mom was studying Sanskrit; while others were finding friendship at Tupperware parties, her mom was finding enlightenment at the ashram. It wasn't until she was gone that Brown-Worsham began to appreciate her mother's bravery and the profound role that yoga would play in her adult life. In Namaste the Hard Way: A Daughter's Journey to Find Her Mother on the Yoga Mat, Brown-Worsham deftly captures the universal experience of the mother-daughter bond, teenage angst, and coming of age while sharing the life skills learned in her journey to becoming a Yogi.
This is not your mother's yoga book. The author writes with the heartfelt humor of a teenage girl going through loss, love, and self-discovery. As a rebellious child with a racing mind, Brown-Worsham takes us through the wisdom she learned from the guidance and loss of her passionate, yoga-practicing mother who was taken too soon by breast cancer.
After her mother's death, Brown-Worsham ran as far away from yoga as she could until a running injury left her needing the very thing she was running from. It was there—on the mat— that she processed her grief and found her mother again. In the space of her yoga mat, she and her mother connect across time.
According to ancient Indian philosophy, Sanskaras are the thought patterns and scars that arise from our personal pain. In Namaste the Hard Way, pain and self-discovery are brilliantly paired with the grounding teachings of yoga. Inhalations help us strengthen and embolden. Exhalations help us surrender and accept. Every posture is a metaphor, every class an opportunity to see with new eyes. The story of adolescence is one that we can all resonate with, and the teachings of yoga offer us guidance, wisdom, and strength.
About the Author:
Sasha Brown-Worsham is a writer, editor and yoga teacher whose work has been featured in The New York Times, Cosmopolitan, Redbook, Boston Globe, and countless other publications. She was the lifestyle editor at both Cafe Mom and She Knows Media for many years and was also a staff writer at both publications. Currently, she is a contracted writer for Destination America's blog, The Hauntist. She has written on everything from haunted corn fields to Bernie Sanders to onesies and SUP Yoga.
Namaste the Hard Way: A Daughter's Journey to Find Her Mother on the Yoga Mat
By Sasha Brown-Worsham
HCI Books
ISBN-9780757320606
$15.95
September 2018
Available wherever books are sold or to order directly from the publisher, contact: (800) 441-5569 or www.hcibooks.com
Golden Leaf Holdings’ Subsidiary, Medical Marijuana Group Corp, Acquires Sales License from Health Canada
TORONTO – September 24, 2018 – Golden Leaf Holdings Ltd. (“Golden Leaf” or the “Company”) (CSE:GLH) (OTCQB:GLDFF), a cannabis company with cultivation, production and retail operations built around recognized brands, today announced its 100 percent-owned Canadian subsidiary Medical Marijuana Group Corporation (“MMG”), a Licensed Producer in St Thomas, Ontario received its Sales License from Health Canada on Friday September 21, 2018. The news is a significant milestone for the Canadian LP.
Asked for comment, President of MMG Phillip Millar said, “We are thrilled with the news. All of our product in inventory will move immediately to buyers and could contribute approximately US$900,000 to third quarter GLH revenue. All 2018 product we can grow is already pre-sold under very favourable wholesale pricing. Our plan for 2019 is to secure direct-to-customer licensing and supply the profitable medical patients’ market with the assistance of our sister company MMC, also 100 percent-owned by GLH, which currently has patient lists that can account for 100 percent of our production capacity. We expect the complete value chain of seed to consumer will result in high profit margins.
Today, we have one of Canada's most advanced indoor grow operations with exceptional yields and preeminent cannabis products. Now that the sales license has been approved, we are able to ship our top-quality product to a waiting wholesale buyer. Numerous new orders are now being received on a daily basis. We want to leverage this momentum to stay focused on achieving profitability and creating value for shareholders.”
William Simpson, CEO of Golden Leaf Holdings, commented, “We anticipate this news to contribute to our third quarter revenue numbers and foster increased investor confidence in our company. With recreational cannabis becoming legal in Canada in the fourth quarter of 2018, we are well situated to take advantage of anticipated product demand in an exciting market. This accomplishment is the first of many steps that establishes us as an international cannabis company.”
When asked about next steps, Mr. Millar replied, “MMG has submitted Building Permit applications with the St. Thomas Municipality for expanded space to allow for cannabis oil and edibles production. Indications are that the Canadian Government will approve the production and sale of such products about a year from now. MMG expects to be able to leverage Golden Leaf’s existing capabilities with these products that it currently produces and sells on the west coast of the United States.”
To be added to the distribution list please email ir@goldenxtrx.com with “GLH” in the subject line.
About Golden Leaf Holdings
Golden Leaf Holdings Ltd. is a Canadian company with operations in multiple jurisdictions including Oregon, Nevada and Canada, with cultivation, production and retail operations built around recognized brands. Golden Leaf distributes its products through its branded Chalice Farms retail dispensaries, as well as through third-party dispensaries. Golden Leaf’s cannabis retail operations and products are designed with the customer in mind, focused on superlative in-store experience and quality products. Visit goldenleafholdings.com to learn more.
New Poll: Canadians Strongly Agree that Access to Affordable Prescription Medicines is Most Important Priority for NAFTA 2.0
TORONTO, Sept. 24, 2018 /CNW/ - A new poll confirms that Canadians do not want their access to generic and biosimilar medicines traded away under a new NAFTA deal.
There are several proposals on the table in the NAFTA negotiations that would require changes to Canada's laws and delay when lower-cost generic and biosimilar drugs can enter the market. This includes longer periods of data protection for expensive biologic drugs. If Canada were to adopt the proposals, every single Canadian would be negatively impacted by the billions of dollars in additional drug costs created through delayed access to generic and biosimilar medicines.
The poll found that Canadians feel that access to more affordable prescription medicines is much more important than any other area of negotiation that has dominated the media coverage of the NAFTA negotiations – including supply management system for agricultural products, automotive issues, exemptions for cultural industries and investor-state dispute resolution.
Canadians feel that NAFTA 2.0 should increase access to generic and biosimilars medicines. Canadians believe that access to affordable prescription medicines is the most important outcome of NAFTA 2.0, and four in five feel that it's important that NAFTA revisions should not delay Canadians access to more affordable versions of expensive biologic drugs. Four in five Canadians also say it's important that NAFTA 2.0 not create new barriers for the implementation of National Pharmacare in Canada.
Two in three Canadians say it is very important that NAFTA 2.0 does not increase prescription drug costs, delay access to affordable drugs or limit the options of prescription drug coverage.
More than 80 per cent of Canadians say it's important that NAFTA 2.0 put Canadians' access to affordable prescription drug coverage ahead of the profits of brand-name drug companies based in the United States.
"This poll confirms that Canadians do not support any concessions in a new NAFTA that will delay their access to more affordable generic and biosimilar medicines," said Jim Keon, President of the Canadian Generic Pharmaceutical Association. "The CGPA urges the Government of Canada to stand firm and not trade away timely access to generic and biosimilar medicines in a new NAFTA.
"Any such concessions would be harmful to Canadians, harmful to our industry and provide an enormous gift to the brand-name pharmaceutical industry – an industry that already enjoys some of the highest prices in the world for their products and some of the world's most favourable IP laws, while making virtually no investments in Canada."
About the Poll
The poll was conducted by Morning Consult for the Canadian Generic Pharmaceutical Association from September 14-16, 2018, among a sample of 2,203 Adults. The interviews were conducted online and the data were weighted to approximate a target sample of Adults based on age, race/ethnicity, gender, educational attainment and region. Results from the full survey have a margin of error of plus or minus two percentage points. To learn more about the poll, please visit www.canadiangenerics.ca/newnafta/
About the Canadian Generic Pharmaceutical Association
The Canadian Generic Pharmaceutical Association (CGPA) represents Canada's generic pharmaceutical industry. The industry plays an important role in controlling health-care costs in Canada. Generic drugs are dispensed to fill more than 71 percent of all prescriptions but account for account for only 21 percent of the $28-billion Canadians spend annually on prescription medicines:
SOURCE Canadian Generic Pharmaceutical Association