New 12-month analysis data from ETNA-AF non-interventional study show low bleeding and intracranial hemorrhage (ICH) rates in frail and elderly AF patients on LIXIANA® (edoxaban) during routine clinical care

• Newly presented data provide reassurance around edoxaban use in vulnerable populations of frail, elderly and renally impaired patients 
• Clinician's perception of frailty found to potentially be a better marker of clinical outcomes than age
• The global ETNA-AF program, which includes ETNA-AF-Europe, is the largest prospective, non-interventional study investigating a single NOAC to date

LAVAL, QC, Aug. 31, 2020 /CNW Telbec/ - Servier Canada announces one-year results of four sub-analyses from the European and global ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation) program, a non-interventional safety study evaluating edoxaban (known by the brand name LIXIANA^®) treatment in routine clinical practice in >26,000 patients around the world with atrial fibrillation (AF).^i,ii,iii,iv New 12-month data from the European and global ETNA-AF registries showed rates of bleeding and intracranial hemorrhage (ICH) were considered low by the authors' assessment in frail and elderly patients in routine clinical care.^i,ii,iii Findings are available virtually at ESC Congress 2020, the annual meeting of the European Society of Cardiology, 29 August – 01 September, and are part of the largest prospective, non-interventional study program investigating a single non-vitamin K antagonist oral anticoagulant (NOAC) in patients with non-valvular atrial fibrillation (NVAF) to date. 

In vulnerable populations such as the elderly, frail and those with renal impairment – a common comorbidity for people with AF – anticoagulation for stroke prevention is often not prescribed due to the risk of bleeding, despite these patients being among those most at risk for ischemic events like stroke.^v However, outcomes from ETNA-AF reinforce the effectiveness and safety of edoxaban in these populations. 

"Elderly and frail patients have been underrepresented in certain AF stroke prevention trials, leaving a lack of evidence to support routine NOAC use in these patients," said Dr Ameet Bakhai, Consultant Cardiologist & Cardiovascular R&D Director Royal Free London NHS Trust, UK. "However, these new data should provide clinicians with some confidence of edoxaban's efficacy and safety profile to reduce the risk of stroke for the elderly and frail AF populations." 

ETNA-AF-Europe Registry Outcomes: Frailty and renal function 
Anticoagulation presents multiple challenges in patients who are frail, as well as those with both frailty and renal impairment.^vThe first of the two data analyses from the 13,092 patient-wide ETNA-AF-Europe registry, assessed key clinical outcomes and risk scores in frail and elderly patients versus non-frail or younger patients correspondingly.ⁱ Frailty – commonly defined as those at increased risk of disability, hospitalization, and mortality^vi – was determined by physician perception.ⁱ 

Results from 1,392 patients, who were considered frail, showed:ⁱ

• Rates of intracranial hemorrhage (ICH) remained low by the investigators' assessment, regardless of frailty status or age, despite frail patients being four times more likely to suffer mortality and presenting with higher rates of major bleeding compared to the non-frail cohort 
• Per year, ICH occurred in 0.15% of patients in the frail cohort, compared to 0.27% of those in the non-frail cohort 
• Per year, major bleeding occurred in 2.18% of patients in the frail cohort, compared to 0.95% of those in the non-frail cohort 
• Per year, total mortality occurred in 10.43% of patients in the frail cohort, compared to 2.49% of those in the non-frail cohort

In addition, the analysis suggested that clinician's perception of frailty appeared to be a better marker of clinical outcomes than age.ⁱ

In the second analysis from the ETNA-AF-Europe registry, 13,021 patients with renal impairment were observed to evaluate baseline characteristics and assess follow-up outcomes at one-year.ⁱⁱ The presence of AF is linked with a greater risk of developing moderate and severe renal impairment, and clinically, anticoagulation presents multiple challenges in patients with impaired renal function because the pharmacokinetic properties and bioavailability of the treatment are often altered in those patients.^vii,viii Findings of this analysis indicated that across the three groups, who were categorized according to their creatinine clearance (CrCl) levels, those treated with edoxaban had low rates of ICH and hemorrhagic stroke, by the investigators' assessment, and these results were similar in patients across all groups studied.ⁱⁱ Regarding renal function, ICH occurred in 0.18%, 0.32% and 0.17% of patients annually, in the following categories moderate to severe renal disease (CrCl ≤50 mL/min), mild renal disease (CrCl (50–80) mL/min ) and normal renal function (CrCl ≥80 mL/min)respectively, while hemorrhagic stroke occurred in 0.04%, 0.17% and 0.10% of patients in the aforementioned groups, respectively.ⁱⁱ

Global ETNA-AF: Treatment of elderly patients 
Findings from one of two global sub-analyses showed that at 12 months, rates of ICH were consistently low across all age groups, while CV mortality increased numerically with age, but to a lower extent than all-cause mortality.ⁱⁱⁱ Additional findings from the global registry, assessing the safety and effectiveness of edoxaban given at the recommended or non-recommended dose in AF patients during one-year observation in routine clinical practice, showed that edoxaban is being prescribed at the label recommended dose in the vast majority of patients, but that non-recommended edoxaban dosage tends to occur more frequently when the CrCl or body weight was closer to the threshold of dose reduction.^iv

"AF is common in the elderly population as are comorbidities and higher rates of CV events, including bleeding, which all need to be managed with a great deal of consideration for the challenges they present for both clinicians and patients," said Wolfgang Zierhut MD, Executive Director Medical Affairs and Head Thrombosis and Cardiovascular at Daiichi Sankyo Europe. "These latest data show the consistency of edoxaban treatment in providing benefits to a wide range of patients." 

ETNA-AF is one of more than 10 randomized, controlled trials (RCTs), registries and non-randomized clinical studies that comprise the Edoxaban Research Program, EDOSURE.

All of the ETNA-AF non-interventional study data presented at ESC Congress 2020 can be found here.

About ETNA-AF
ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation) is a global program that combines data from distinct non-interventional studies in Europe, East Asia, and Japan in a single database. A total of more than 28,000 patients will be included in the ETNA-AF registries and followed for two years (patients in Europe will be followed for four years). The primary objective of ETNA-AF is to collect information on the use of edoxaban in routine clinical practice, including the safety and efficacy profile in non-preselected patients with NVAF.^{ix,x,xi,xii,xiii}

About AF
AF is a condition where the heart beats irregularly and rapidly. When this happens, blood can pool and thicken in the chambers of the heart causing an increased risk of blood clots. These blood clots can break off and travel through the blood stream to the brain (or sometimes to another part of the body), where they have the potential to cause a stroke.^xiv

AF is the most common type of heart rhythm disorder affecting approximately 350,000 Canadians and is associated with substantial morbidity and mortality.^xv,xvi Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.^xvii One in five of all strokes are as a result of AF.^xvii 

About Edoxaban
Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting.  Edoxaban was discovered and developed by Daiichi Sankyo Co., Ltd. On June 27, 2016, Daiichi Sankyo and Servier Canada entered into an agreement whereby Servier Canada would market the oral, once-daily anticoagulant edoxaban in Canada, upon approval by the Canadian health authority. Edoxaban is currently marketed in more than 30 countries and regions around the world.

About the Edoxaban Clinical Research Program 
More than 10 studies, more than 100,000 patients worldwide
Daiichi Sankyo, the company that discovered edoxaban, is committed to expanding scientific knowledge about edoxaban, as demonstrated through research programs evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE) designed to further build on the results of the pivotal ENGAGE-AF and Hokusai-VTE studies.  More than 100,000 patients worldwide are expected to participate in the Edoxaban Clinical Research Program, which is comprised of more than 10 RCTs (randomized, controlled trials), registries and non-randomized clinical studies, including completed, ongoing and future research. Our goal is to generate new edoxaban clinical and real-world-data regarding its use in AF and VTE populations, providing physicians and patients worldwide with greater treatment assurance.

About Servier Canada 
Servier Canada is the Canadian affiliate of Servier Group, an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 149 countries and a total revenue of 4.6 billion euros in 2019, Servier employs 22 000 people worldwide. Entirely independent, the Group reinvests on average 25% of its turnover (excluding generics) every year in research and development and uses all its profits for development. Corporate growth is driven by Servier's constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development. Servier has been present in Canada since 1978.

More information: www.servier.ca

References

COVID-19 Pandemic Has Not Stopped Canadians From Traveling to Lithuania for Joint Replacement

Pandemic has not stopped Canadians from traveling to orthopaedic surgery clinics in Lithuania. Most of these medical tourists come from the province of Alberta. There patients wait for more than a year to have orthopaedic surgeries, while government plans to make waiting times shorter are stuck.

August 31st, 2020. Due to the COVID-19 pandemic Canadian government recommends its citizens to avoid non-essential travel abroad. But medical tourists seeking joint replacement apparently consider their travels essential. As soon as borders with Europe were re-opened in July, orthopaedic patients from Canada came back to Lithuanian orthopaedic clinics. The chief surgeon of Nordothopaedics clinic, the leading international orthopaedic surgery center in Kaunas, Lithuania, said that the number of incoming Canadian patients is not lower than before the lockdown.

"Five patients from Canada came to us in August," stated Prof Šarūnas Tarasevičius, chief surgeon at Nordothopaedics clinic. "It is a very high number, if one considers the distance patients have to travel. Patients say they choose to travel long distances because of the unbearable waiting times at home."

He pointed out that half of all Canadian patients come from the province of Alberta, which has been struggling with long wait times for decades. Waiting for orthopaedic surgeries takes particularly long—the median waiting time between the visit to the general practitioner and the surgery was 62.5 weeks in 2019. Due to an almost complete absence of private healthcare, residents of Alberta have no alternatives in Canada.

Presently the Albertan government has taken steps to make waiting times shorter. The new laws allowing for partial privatization of medical services, including orthopaedic surgery, are under discussion, but they meet strong resistance from political opposition and society. The pandemic has caused additional delays of healthcare reforms and the recent private initiative to build a new orthopaedic surgery clinic in Alberta has also caused public controversy.

While discussion on changes is stuck, joint replacement patients are compelled to wait for surgeries. According to Prof Tarasevičius, their wait is very painful. Most need painkillers, and wear and tear of joints inhibits movement. Long waiting may also lead to further problems: a recent study indicates that 90% of patients wait too long for joint replacement surgeries, which often results in a loss of mobility and deteriorating health.

As Canadian patients themselves testify, waiting times have become too long for them even to consider.

"After a complete hip replacement was recommended by my family doctor, I haven't even gotten in to see the orthopedist surgeon to get on the waiting list," said Brent Stradeski, a 58-year-old Albertan. "Might be a year to three years until an actual surgery! I am a very active person and I could not wait that long. At Nordorthopaedics clinic the entire crew and staff were absolutely wonderful, professional and very caring. Two weeks after the surgery I was at home safe and feeling better than one could have imagined."

Mr. Stradeski applied for hip replacement at Nordorthopaedics clinic in May. His surgery took place in July—as soon as Lithuanian borders became open for travelers from Canada.

Most patients of Nordorthopaedics clinic appreciate quality and professionalism, which first of all depends on the experience of the chief surgeon. In his 15-year-long career Prof Tarasevičius has conducted more than 2000 joint replacement surgeries and co-authored over 150 scientific articles. The clinic offers hip and knee replacement packages. The packages include a 7-day or a 14-day recovery in Druskininkai. The hip replacement package with a 7-day recovery starts at €7,500, while the knee replacement package with a 7-day recovery starts at €7,530.

-END -

ABOUT NORDORTHOPAEDICS

Nordorthopaedics is a private clinic in Kaunas, Lithuania, part of Nordclinic, offering high-quality services and focusing on foreign patients. It is equipped with modern diagnostic and surgical facilities. Medical professionals at the clinic speak fluent English and show personal attention to every patient. www.nordorthopaedics.com/en.

Vaccination Even More Important in COVID Times

TORONTO, Aug. 31, 2020 /CNW/ - As the province prepares for the new school year, the Ontario Medical Association (OMA) is reminding parents to ensure their children's vaccinations are up to date.

When much of Ontario's economy shut down and people were asked to practice physical distancing, doctors' offices remained open and continued to provide vital services, including childhood vaccinations. However, many people were unaware their doctor was seeing patients in person or were concerned about visiting their doctor's office. As a result, many children may be behind on their scheduled vaccines.

"During COVID, doctors have seen a dramatic decrease in the number of parents bringing their children for routine vaccinations. Immunizations are crucial in preventing children and their communities from outbreaks of vaccine-preventable diseases, said OMA President Dr. Samantha Hill. "To protect our most vulnerable we need to ensure that as many people as possible are vaccinated." 

Vaccination is one of the most successful public health interventions in history. It has led to the elimination and control of diseases that were once common in Canada. Before vaccines, many Canadian children became severely ill or died from infectious diseases such as smallpox, polio, diphtheria, measles, and pertussis.

Vaccines are safe and they protect us all. All vaccines used in Canada are rigorously tested through multiple phases of trials before they are used. It is more likely that one becomes ill from a vaccine-preventable disease than from a vaccine. 

About the OMA 
The Ontario Medical Association represents Ontario's 43,000 plus physicians, medical students and retired physicians, advocating for and supporting doctors while strengthening the leadership role of doctors in caring for patients. Our vision is to be the trusted voice in transforming Ontario's health-care system.  

SOURCE Ontario Medical Association

Ontario’s Russell Alexander Law Firm ExpandsUniversity Scholarship Due to Coronavirus
Family lawyers extend deadline, add technology stipend to help offset costs of studying the field of law

LINDSAY, Ontario—Russell Alexander Collaborative Family Lawyers is offering a university scholarship to offset the costs of studying the legal profession as a way to give back and support the Canadian legal field with the deadline to apply extended to September 30. It has also increased the size of the scholarship it’s offering to offset the costs of technology.

“During these unprecedented times with Covid-19, we feel providing this scholarship was more important than ever before,” said founder Russell Alexander. “And given the uncertainty over the academic year, we wanted to give students a little more time to apply.”

Since 2017, the Lindsay, Ontario-based law firmhas given $2,000 to a student who has an interest in joining or studying the legal profession. This year, the scholarship will also include a technology stipend worth an additional $500 to buy a personal computer or tablet needed to take classes online.

This scholarship is open to Canadian students who will graduate from high school in the current academic year. Students must have an average of 80 percent or higher GPA at their current school and an interest in joining the legal community.

To apply, students must fill out an application form on the Russell Alexander Law Scholarship page, write a 1,000-word essay on a family law issue and upload a high-school transcript, resume and recommendation letter. 

“Reading through the submissions is always one of the highlights of our year,” added Alexander. “It gives us hope to see so many students who are excited about the legal profession share their thoughts and experiences with us.”

For more information and to apply to the Russell Alexander Law Scholarship, visit: http://bit.ly/RussellAlexanderLawScholarship
                                                                                                                                                       ***

RussellAlexander Collaborative Family Lawyers 

Russell Alexander Collaborative Family Lawyers is committed to practicing exclusively in the area of family law in Ontario dealing with all aspects, including separation and divorce, child custody and access, spousal support, child support, and division of family property. A team of lawyers provide guidance from start to finish, helping clients identify and understand the legal issues as well as the options and opportunities available through the transition. The firm has offices in Lindsay, Whitby, Oshawa, Markham, Peterborough and Toronto, Ontario. 

For more information, visit: http://www.russellalexander.com

Patients and providers send 2 Million secure messages for better health

CALGARY, AB, Aug. 28, 2020 /CNW/ - Healthcare professionals and patients have now exchanged more than 2 Million secure messages using Brightsquid Secure-Mail. This milestone for healthcare in Canada proves the importance of secure messaging in the delivery of care going forward and establishes Secure-Mail as one of the most used privacy compliant messaging services in the country.

Each Secure-Mail message sent replaces a fax, a phone call, a letter mailed, or an in person visit to deliver greater efficiency and effectiveness into the healthcare system.

Secure messaging between providers and patients is shown to improve health outcome measures, increase patient satisfaction, and increase clinic capacity by 11%. Clinics using Brightsquid Secure-Mail have reduced diagnostic wait times by more than 90% and doubled the number of patients they are able to see in a day.

The COVID-19 pandemic drove demand for Secure-Mail in support of virtual care and social distancing. Thousands more clinics join the Brightsquid system, and patient use of the secure messaging service tripled. The Government of Alberta's MyHealth Records service has integrated Secure-Mail to improve remote communications between patients and providers. Recently, large groups of healthcare providers and other regional health authorities have also implemented Brightsquid Secure-Mail to improve patient access to clinics while keeping data private.

Top uses for the service are consultations between providers, sending pre-appointment forms to patients, and patients sending images or videos of their symptoms for assessment. Clinics use secure-Mail to manage and triage patient requests more efficiently than can be done using phone.

"We believe that secure convenient communications will do more to advance healthcare in the next 5 years than any single drug or medical device," explains Rohit Joshi, Brightsquid CEO. "Achieving this milestone on our journey to help improve quality of life for patients and providers is evidence that Secure-Mail plays a vital role in the new reality for healthcare."

About Brightsquid Secure Communications Corp.:

Brightsquid Secure-Mail is a Calgary-based secure email service that connects over 160,000 users across North America. It simplifies communication between patients and their healthcare providers to accelerate care, increase access, and create clinic efficiencies that benefit the entire healthcare system.

SOURCE Brightsquid Secure Communications Corp.

True Story of Survival Opens Minds and Dialogues about Mental Health

New York NY, August 26, 2020 — Mark Henick stood precariously on the wrong side of the railing on a crumbling, concrete overpass. The bridge spanned two realities and, for Henick, had become a symbol of escape — in one form or another. A voice behind him tried to help. A crowd gathered. Siren lights flashed in his peripheral vision. Surrounded but still alone, Henick let go.

So-Called Normal: A Memoir of Family, Depression and Resilience from Mark Henick is a vital and triumphant story of perseverance and recovery by one of North America’s foremost advocates for mental health.

Henick’s near-death experience on the overpass that night would alter his emotional orbit just enough that his exit from a psychiatric ward following that suicide attempt in 2003 would be his last. His transformation didn’t happen overnight — it was a gradual process punctuated with new challenges and setbacks — but slowly, his patterns reversed and he began a profound, “upward” spiral toward recovery.

So-Called Normal chronicles Henick’s youth and the events that led to that fateful night on the bridge and the experiences and transformation that followed. It is a vivid and personal account of a boy who had to deal with the breakdown of his parents’ marriage, an abusive stepfather, bullying and trauma — all while trying to navigate his progressively worsening mental health. In the backdrop is a community that didn’t talk about mental illness, one where silence and maintaining the comforts of “normal” was paramount. 

So-Called Normal is not a “misery memoir” about suicide — it’s a gripping, inspirational story of survival that has already touched the hearts of many, including television personality Rosie O’Donnell.

“Mark Henick is a powerful storyteller. His vivid account of his early years as a depressed, suicidal teenager is a page-turner. So-Called Normal is beautifully written, heart-wrenching, and hopeful. Necessary reading for anyone who wants a peek inside the mind of someone who journeyed through mental illness and found hope on the other side,” O’Donnell said.

Author Mark Henick’s TEDx talk about being saved from death by a stranger is one of the most watched in the world and has been viewed millions of times. His search for “the man in the brown jacket” whose bravery and strong arms kept him from falling to his death went viral around the world (and was successful!). Henick has been on television and radio and has written many articles on mental health. He has hosted more than 60 intimate conversations about mental health with notable public figures and celebrities on his podcast, So-Called Normal, and has executive produced and hosted the Living Well podcast for Morneau Shepell. Henick has served on the board of directors for the Mental Health Commission of Canada, and was the president of a provincial division of the Canadian Mental Health Association — the youngest person in either role. He has worked as a frontline clinician, a program manager and the national director of strategic initiatives for CMHA. Currently the CEO and principal strategist for Strategic Mental Health Consulting, Mark Henick is in high demand as an international keynote speaker on mental health recovery.

To watch Henick’s powerful TEDx talk, please visit https://youtu.be/D1QoyTmeAYw. For more information, please visit www.markhenick.com or connect with the author on the following social media sites: www.facebook.com/markhenick/; https://twitter.com/markhenick; and www.youtube.com/markhenick.

So-Called Normal: A Memoir of Family, Depression and Resilience

Publisher: HarperCollins

Release Date: January 12, 2021

ISBN-10: 1443455032 

ISBN-13: 978-1443455039

Available from Amazon.com, BarnesandNoble.com, Audible and others 

###

Scientists use blood test to predict who is likely to develop psychotic disorders

DUBLIN, Aug. 26, 2020 -- Scientists have discovered that testing the levels of certain proteins in blood samples can predict whether a person at risk of psychosis is likely to develop a psychotic disorder years later.

The study is published in the current edition of JAMA Psychiatry and was led by researchers from RCSI University of Medicine and Health Sciences.

Based on certain criteria, such as mild or brief psychotic symptoms, some people are considered to be clinically at high risk of developing a psychotic disorder, such as schizophrenia. However, only 20% to 30% of these people will actually go on to develop a psychotic disorder. 

The researchers analysed blood samples taken from people at clinical high risk of psychosis. These individuals were followed up for several years to see who did and did not develop a psychotic disorder.

After assessing the proteins in blood samples and using machine learning to analyse this data, the scientists were able to find patterns of proteins in the early blood samples that could predict who did and did not develop a psychotic disorder at follow-up. 

Many of these proteins are involved in inflammation, suggesting that there are early changes in the immune system in people who go on to develop a psychotic disorder. The findings also suggest that it is possible to predict their outcomes using blood samples taken several years in advance.

The most accurate test was based on the 10 most predictive proteins. It correctly identified those who would go on to develop a psychotic disorder in 93% of high-risk cases, and it correctly identified those who would not in 80% of cases.

“Ideally, we would like to prevent psychotic disorders, but that requires being able to accurately identify who is most at risk,” said Professor David Cotter, the study’s senior and corresponding author and professor of molecular psychiatry at RCSI.

“Our research has shown that, with help from machine learning, analysis of protein levels in blood samples can predict who is at truly at risk and could possibly benefit from preventive treatments. We now need to study these markers in other people at high risk of psychosis to confirm these findings.” 

A patent application has been filed, and the research team is working to commercialise this research through licensing or partnering with industry.

This research was funded by the European Network of National Schizophrenia Networks Studying Gene-Environment Interactions (EU-GEI) Project (Project EU-GEI) from the European Community’s Seventh Framework Programme, by the UK Medical Research Council and by the Irish Health Research Board.

David Mongan, RCSI PhD student and Irish Clinical Academic Training (ICAT) Fellow, analysed the data with the supervision of Professor David Cotter and Professor Mary Cannon from the RCSI Department of Psychiatry. The ICAT programme is supported by the Wellcome Trust and the Health Research Board, the Health Service Executive National Doctors Training and Planning and the Health and Social Care, Research and Development Division, Northern Ireland. The blood samples were analysed in the UCD Conway Institute under the supervision of Dr Gerard Cagney. 

About RCSI University of Medicine and Health Sciences

Ranked number one globally for Good Health and Well-being in the Times Higher Education (THE) University Impact Rankings 2020, RCSI University of Medicine and Health Sciences is an international not-for-profit university, with its headquarters in Dublin. 

RCSI is exclusively focused on education and research to drive improvements in human health worldwide. It is among the top 250 universities worldwide in the THE World University Rankings (2020) and its research is ranked first in Ireland for citations. RCSI has been awarded Athena Swan Bronze accreditation for positive gender practice in higher education.

Visit the RCSI MyHealth Expert Directory to find the details of our experts across a range of healthcare issues and concerns. Recognising their responsibility to share their knowledge and discoveries to empower people with information that leads them to better health, these clinicians and researchers are willing to engage with the media in their area of expertise.

HPIC Sends First Canadian Shipment of Medicines to Beirut

TORONTO, Aug. 26, 2020 /CNW/ - Thanks to the generosity of Canadian pharmaceutical companies, financial donors and volunteers, Health Partners International of Canada (HPIC) is sending the first Canadian shipment of medicines (valued at $400,000) to the people of Beirut who were, and continue to be, affected by the explosion on August 4^th that killed hundreds and injured thousands.

The initial shipment of primary care medicines left HPIC's distribution centre in Oakville today and will be departing from Toronto, Ontario to Beirut, Lebanon on Friday, August 28^th. The medicines will be distributed to over 20 hospitals, primary healthcare centres, dispensaries and clinics in Beirut.

"With the escalating unprecedented economic crisis in Lebanon, hospitals were already struggling so HPIC is very pleased to provide this first shipment of donated Canadian medical aid to the people of Beirut", says Marcelle McPhaden, HPIC's president and CEO. She added, "we are in continuous contact with our partners on the ground and everyday, we are continuing to assess and respond to the urgent needs of individuals, families and health facilities in Lebanon." 

This first shipment comprises seven pallets of antibiotics, analgesics, anti-inflammatories and medicines for respiratory and cardiovascular diseases donated by HPIC's pharma industry partners.

"We are very thankful to our faithful donors for their financial support and to our pharmaceutical partners who responded right away to make this shipment possible. Canadian donors continue to step up and respond to international crises. This is a proud moment for all of us." says McPhaden. "Our goal is to send more than $1 million worth of medicines and medical supplies in subsequent shipments."

Since 2001, HPIC has shipped close to $18 million of medicines and medical supplies to Lebanon to help provide care to those in need. In 2019 alone, HPIC provided $1.8 million of donated medicines to 451 health facilities and dispensaries and served 150,000 Lebanese citizens and 15,000 refugees. 

HPIC is continuing its appeal to the healthcare industry and the Canadian community to respond to this disaster and looks forward to sending further much-needed aid in the coming weeks. 

ABOUT HPIC 

Health Partners International of Canada (HPIC) is a Canadian registered charity dedicated to increasing access to medicine and improving health for the world's most vulnerable people in the developing world.  

HPIC works with Canada's pharmaceutical and healthcare industry to treat over 1 million people every year through a well-established network of Canadian volunteers and global partners.  We equip medical mission teams, stock clinics and hospitals in impoverished communities, mobilize medical relief during emergencies and build local capacity through long-term projects.  

SOURCE Health Partners International of Canada

For further information:

For media inquiries or for more information, please contact: Samantha Burnside, Manager, Marketing and Communications, 905-670-1990 x205, sburnside@hpicanada.ca; For information on donating medical products, please contact: Heather Watts, Director, Health Industry Relations, hwatts@hpicanada.ca; For information on making a financial donation, please contact: Dayana Gomez, Director, Philanthropy, dgomez@hpicanada.ca 

Love hormone also forms important link between stress and digestive problems

 UNDER STRICT EMBARGO UNTIL 01.00 GMT 31 AUGUST 2020 

Not for publication or broadcast before this time 

Peer reviewed                                       Experimental study                                    Animals 

New research published today in The Journal of Physiology shows that oxytocin, known as the love hormone, plays an important role in stress’ disruption of digestion such as bloating, discomfort, nausea, and diarrhea.  

Stress disrupts gastrointestinal functions and causes a delay in gastric emptying (how quickly food leaves the stomach). This delay in gastric emptying causes bloating, discomfort, and nausea and accelerates colon transit, which causes diarrhea.  

Oxytocin, an anti-stress hormone, is released from the hypothalamus in the brain which acts to counteract the effects of stress. For a long time, the actions of oxytocin were believed to occur due to its release into the blood with only minor effects on the nerves within the brain that regulate gastrointestinal functions.  

The study used new ways to manipulate the neurons and nerves (neurocircuits) that oxytocin released from the hypothalamus acts upon and measured the effects on the response of gastric emptying to stress. They have shown that, contrary to previous assumptions, these oxytocin circuits play a major role in the response of the stomach to stress.  

Activation of these oxytocin circuits reversed the delay in gastric emptying that occurs normally in response to stress, by increasing muscle contractions (motility) of the stomach, while inhibition of these neurocircuits prevented adaptation to stress.  

The new research, conducted at Penn State University- College of Medicine and was sponsored by a grant from the National Institute of Health, USA, employed cutting-edge tools that allow selective manipulation of the circuits that receive hypothalamic oxytocin inputs together with simultaneous measurements of gastric emptying and motility in response to stress.  

The authors used a rat model of different types of stress - acute stress, appropriate adaptation to stress, and inappropriate adaptation to stress. The authors infected the neurons controlling the oxytocin nerves and neurocircuits with novel viruses that allowed them to be activated or inhibited and measured muscle activity in the stomach, as well as gastric emptying (the time for food to leave the stomach).  

The researchers have shown that these oxytocin neural circuits play a major role in the gastric response to stress loads. Indeed, their activation reversed the delayed gastric emptying observed following acute or chronic responses to stress, thus increasing both gastric tone and motility. Conversely, inhibition of these neurocircuits prevented adaptation to stress thus delaying gastric emptying and decreasing gastric tone.   

These data indicate that oxytocin influences directly the neural pathways involved in the stress response and plays a major role in the gastric response to stressors. ​ 

The ability to respond appropriately to stress is important for normal physiology functions. Inappropriate responses to stress, or the inability to adapt to stress, triggers and worsens the symptoms of many gastrointestinal disorders including delayed gastric emptying and accelerated colon transit.  

Previous studies have shown that the nerves and neurocircuits that regulate the function of gastric muscle and emptying respond to stress by changing their activity and responses.  

In order to identify targets for more effective treatments of disordered gastric responses to stress, it is important to first understand how stress normally affects the functions of the stomach. Their study provided new information about the role that oxytocin plays in controlling these nerves and circuits during stress and may identify new targets for drug development. 

Commenting on the study R Alberto Travagli said: 

“Women are more vulnerable to stress and stress-related pathologies, such as anxiety and depression, and report a higher prevalence in gastrointestinal disorders. Our previous studies showed that vagal neural circuits are organized differently in males versus females. We are now finalizing a series of studies that investigate the role and the mechanisms through which oxytocin modulates gastric functions in stressed females. This will help to develop targeted therapies to provide relief for women with gastrointestinal disorders. 

ENDS 

Notes for Editors 

1. Full paper title: Link to paper https://physoc.onlinelibrary.wiley.com/doi/abs/10.1113/JP280023 (link will only work after the embargo date. Before then, please email the press office for a copy of the paper) 

2. 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  

3. 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  

Laurent Pharmaceuticals Receives Approval from FDA to Initiate its COVID-19 Phase 2 Clinical Trial in the United States

The Phase 2 study aims to evaluate the dual antiviral and inflammation-controlling effects of the company's LAU-7b oral drug candidate against COVID-19 infection

MONTREAL, Aug. 27, 2020 /CNW Telbec/ - Laurent Pharmaceuticals Inc., a Montreal-based biopharmaceutical company, today announced that it has received approval from the Food and Drug Administration (FDA) to start enrolling U.S. patients in RESOLUTION, a multicentric Phase 2 randomized placebo-controlled trial testing once-a-day oral LAU-7b as a potential treatment against COVID-19 disease. RESOLUTION, which is currently ongoing in Canada, will enroll approximately 200 hospitalized COVID-19 patients who will receive either LAU-7B or a placebo for a treatment duration of 14 days. The company is in advanced discussions with a number of U.S. hospitals interested to participate in the trial and is looking to activate them very soon. 

"The main objective of the RESOLUTION study is to demonstrate that LAU-7b is a safe and effective treatment option for COVID-19 patients that are at risk of lung complications because of their age, underlying condition or both," said Dr. Radu Pislariu MD, President and CEO of Laurent Pharmaceuticals. "We hope that treatment with LAU-7b will slow down the disease progression, prevent the respiratory failure requiring mechanical ventilation, and ultimately reduce the number of fatalities due to the COVID-19," added Dr. Pislariu.

LAU-7b, which showed potent antiviral effects in-vitro against both SARS-CoV-2 and MERS-CoV coronaviruses, is also being developed for its unique inflammation-controlling properties by acting on the resolution phase of the inflammation process, a natural mechanism that keeps the body's inflammatory response under control without inducing immune-suppression (a "pro-resolving" effect). The pro-resolving proprieties of LAU-7b are currently under evaluation in a Phase 2 study in Cystic Fibrosis (CF), aiming to treat the exaggerated inflammatory response that leads to irreversible lung damage in these patients. 

"New clinical research approaches for COVID-19 aim to combine antiviral with inflammation-controlling treatments," said Dr. Dana G. Kissner, MD, pulmonologist at DMC Harper University Hospital and Professor of Medicine, Wayne State University, in Detroit, Michigan. "During the less critical stages of the disease, we want therapies that fight the virus while keeping the inflammation in check and preventing lung complications. LAU-7b appears to possess both properties in the same molecule, thus bearing the promise of a treatment candidate that addresses multiple key contributors to the severity of COVID-19," added Dr. Kissner. 

The RESOLUTION trial (Clinicaltrials.gov, #NCT04417257) follows the recommendations of the World Health Organization (WHO) Master Protocol for COVID-19 clinical studies. It will measure the patient health status on a 7-point ordinal scale to evaluate the disease progression and inform the primary and secondary endpoints of the study. The study will also measure the duration of hospitalization and improvement in quality of life.

About Laurent Pharmaceuticals 

Laurent Pharmaceuticals is a clinical stage biopharmaceutical company focusing on life-threatening inflammatory diseases that are inadequately addressed by current anti-inflammatory therapies. The company's lead drug candidate, LAU-7b, is a unique, patent-protected oral formulation of fenretinide, ideally applicable to a once-a-day low dose treatment regimen. LAU-7b has the potential to trigger the resolution phase of inflammation and is currently in a Phase 2 study involving adult patients with Cystic Fibrosis. Fenretinide also showed potent antiviral effects in vitro against the SARS-CoV-2 virus, and the company is currently conducting a Phase 2 clinical trial with LAU-7b in hospitalized COVID-19 patients. Fenretinide is an investigational retinoid that has a well-documented safety profile established in more than 3,000 patients, in various indications. For more information, please visit www.laurentpharma.com. 

SOURCE Laurent Pharmaceuticals