Science
This week brings around new research from an international study that claims an average sodium intake does not harm your health; NSERC grants 1.65 million for a new biomedical technology program; Prometic Life Sciences elucidates the mechanism of action of their proprietary drug; and Milestone Pharmaceuticals randomises their first patient in their phase 3 clinical trial. Keep on listening to hear all the juicy details! +++++ No need to fret when you ask someone to pass you the salt at the dinner table anymore. New research by scientists of the Population Health Research Institute (PHRI) of McMaster University and Hamilton Health Sciences as well as researchers from 21 countries suggests sodium intake does not increase health risks except for those who eat more than five grams a day – an equivalent of 2.5 teaspoons. This large-scale international study expresses for most individuals that this is good news. Any health risk of sodium consumption is virtually eliminated if people improve their diet quality by adding fruits, vegetables, dairy foods, potatoes, and other potassium rich foods. The study followed 94,000 people, aged 35 to 70, for an average of eight years in communities from 18 countries around the world and found there an associated risk of cardiovascular disease and strokes only where the average intake is greater than five grams of sodium a day. China is the only country in their study where 80 per cent of communities have a sodium intake of more than five grams a day. In the other countries, most communities had an average sodium consumption of 3 to 5 grams a day. The World Health Organization recommends consumption of less than two grams of sodium — that’s one teaspoon of salt — a day as a preventative measure against cardiovascular disease, but there is little evidence in terms of improved health outcomes that individuals ever achieve at such a low level. The American Heart Association recommends even less — 1.5 grams of sodium a day for individuals at risk of heart disease. Andrew Mente, first author of the study and a PHRI researcher says, “Only in the communities with the most sodium intake — those over five grams a day of sodium – which is mainly in China, did we find a direct link between sodium intake and major cardiovascular events like heart attack and stroke. In communities that consumed less than five grams of sodium a day, the opposite was the case. Sodium consumption was inversely associated with myocardial infarction or heart attacks and total mortality, and no increase in stroke.” Researchers found that all major cardiovascular problems – including death – decreased in communities and countries where there is an increased consumption of potassium which is found in foods such as fruits, vegetables, dairy foods, potatoes and nuts, and beans. Martin O’Donnell, co-author of the report, an associate clinical professor of medicine at McMaster says that most previous studies relating sodium intake to heart disease and stroke were based on individual-level information, and that public health strategies should be based on best evidence. Their findings demonstrate that community-level interventions to reduce sodium intake should target communities with high sodium consumption and should be embedded within approaches to improve overall dietary quality. There is no convincing evidence that people with moderate or average sodium intake need to reduce their sodium intake for prevention of heart disease and stroke. This study lends a hand to simmer down those creeping thoughts of sodium consumption and health issues. Of course, it is still best to use in moderation; but next time someone asks you to pass the salt, you can now more comfortably allow your worry to subside. +++++ Medical innovations improve and save lives. It for this reason that Canada invests so heavily into the health and life sciences. But when it comes to health technology, innovative designs like prosthetic limbs or pacemakers must be designed by a special type of engineer – one who solve engineering problems and can identify medical technology needs. Catherine Burns, professor of systems design engineering and executive director of the Centre for Bioengineering and Biotechnology, has been awarded a Collaborative Research and Training Experience Program (CREATE) grant to establish a biomedical engineering graduate program that will help produce this type of engineer. The $1.65 million grant awarded by the Natural Sciences and Engineering Research Council of Canada (NSERC) will help fund a new program in global biomedical technology research and innovation at Waterloo starting in the fall of 2018, the only one of its kind in Canada. Burns says that most students come out of biomedical engineering graduate programs as great researchers, but not necessarily with a good understanding of how the industry works. That this program will produce students who know both the research side and the business side of the industry. To understand the needs of medical technology users, students will get out into the field to work alongside clinicians and patients to better understand real-life scenarios before developing solutions. Grand River Hospital is one of the partners to the program, as well as Starfish Medical and Synaptive Medical – both of which are very successful Canadian medical device companies. The curriculum at Waterloo will include clinic and industry internships, commercialization courses, international exchanges, and professional skills workshops. Students will graduate knowing how to work with patients and clinicians with understanding of medical device regulation. They will also have the skills and industry contacts in place to help secure jobs in the biomedical industry or commercialize their own inventions. Charmaine Dean, the vice president of university research says that the technical expertise, professional skills, and interdisciplinary experience students gain in this program will produce biomedical engineers capable of transforming the Canadian health technology landscape and is another step in growing Waterloo’s role in the biotechnology and research ecosystem. There is a proposed initiative for the program at Toronto Western Hospital, where a Critical Care physician manages a large amount of data on brain injuries. The goal would be to integrate the data with data from laboratory and patient records, which will provide new insights into the complex physiological relationships in brain injury patients. Students in the program will work with the physician to acquire an understanding of brain injuries, and then develop a data integration solution. Each student will be part of a team that includes a research supervisor, a clinician, and the manager of a biomedical engineering company. Before commencing their research, students will need to prove that they’ve spent time with clinicians and patients in settings relevant to their area of research. This will help ensure that the solutions they develop are viable and easier to commercialise. Overall, this one-of-a-kind program will continue to make Canada an economic powerhouse and punch above its weight in health and life sciences. +++++ Prometic Life Sciences Inc. announces the publication of a paper that further elucidates the mechanism of action of its lead drug candidate, PBI-4050, on liver fibrosis in the Journal of Pharmacology and Experimental Therapeutics. The drug’s clinical activity has already been shown to significantly reduce liver and cardiac fibrosis in patients in the ongoing Phase 2 clinical trial in patients with Alström syndrome. Dr. Lyne Gagnon, senior author of the paper and Prometic’s vice president of R&D says that studying the mechanism of action of PBI-4050 in liver diseases, including non-alcoholic steatohepatitis (NASH), has clearly demonstrated that PBI-4050 acts through a major signaling AMPK pathway, thus linking metabolism to fibrosis. The data shows the potential therapeutic effects of PBI-4050 in liver fibrosis and non-alcoholic steatohepatitis. There are several stages of liver fibrosis, and if left untreated or without changing significant lifestyle choices, may lead to liver cirrhosis. Pierre Laurin, chief executive officer of Prometic adds that they have seen the benefits of PBI-4050 in reducing liver fibrosis in Alström syndrome patients. With this further validation that the signaling pathway targeted by PBI-4050 is indeed at the core of the genesis of fibrosis in the liver, they are very confident about its potential to address fibrosis-related conditions such as Alström syndrome, and non-alcoholic steatohepatitis. We look forward to initiating our Phase 3 pivotal clinical trial for PBI-4050 in IPF and expanding the program in Alström syndrome.” +++++ Milestone Pharmaceuticals, a clinical-stage cardiovascular company, randomises their first patient in its Phase 3 clinical study of etripamil. Etripamil is a new investigational, rapid-onset, short-acting calcium channel blocker administered intranasally by the patient designed to terminate paroxysmal supraventricular tachycardia (PSVT) episodes wherever they occur. paroxysmal supraventricular tachycardia is a recurring and sporadic heart arrhythmia caused by abnormalities in the cardiac conduction system. The current standard of care to terminate these episodes is intravenous medication delivered in the emergency department. The Phase 3, multicenter, randomized, double-blind, placebo-controlled, event-driven study is planned to be conducted in more than 50 cardiology centers in the United States and Canada and will enroll up to 500 patients. Following an in-office test dose of etripamil, patients will take home either 70 mg of etripamil or placebo for when a paroxysmal supraventricular tachycardia episode occurs. Upon onset of an episode, patients will apply a wireless cardiac monitor to their chest to record their heart rhythm, perform a vagal maneuver, and if symptoms persist, administer study drug. Bruce Stambler, MD, FHRS, Piedmont Heart Institute says that the design of the NODE-301 study of etripamil will allow them to obtain more clinical evidence of the benefits of this potential treatment for paroxysmal supraventricular tachycardia in an outpatient, real-world setting. paroxysmal supraventricular tachycardia is an unpredictable disorder and the potential for a fast-acting therapy to resolve the symptoms of paroxysmal supraventricular tachycardia wherever the episodes occur could significantly reduce the burden this condition puts on patients and the health care system. The primary endpoint of the study is time to conversion of paroxysmal supraventricular tachycardia to sinus rhythm after the administration of study drug as confirmed by a central independent adjudication committee. Secondary study endpoints include relief of symptoms commonly associated with an episode of paroxysmal supraventricular tachycardia such as heart palpitations, chest pain, anxiety, shortness of breath, dizziness, and fainting. Francis Plat, MD, Milestone’s Chief Medical Officer says that the initiation of the NODE-301 study is an example of our ongoing commitment to improve the lives of patients with paroxysmal supraventricular tachycardia. Etripamil, if approved by regulatory authorities, could empower patients to take control of this anxiety-producing arrhythmia without being reliant on chronic medications or trips to an acute-care facility for treatment. The study will enroll patients at least 18 years of age with a documented history of paroxysmal supraventricular tachycardia. Patients receiving study treatment in NODE-301 will be eligible to participate in an open-label extension study (NODE-302) where etripamil will be provided for subsequent paroxysmal supraventricular tachycardia episodes. There are well over a million people in the US living with paroxysmal supraventricular tachycardia, resulting in hundreds of thousands of emergency department and doctor’s office visits each year. There are countless other patients who exist and don’t seek care, suffering through their episodes in silence as the current approved treatment options are unpleasant, inconvenient, and/or costly. Providing a way to self-manage paroxysmal supraventricular tachycardia episodes could offer immediate relief for those living with this arrhythmia. +++++ Well that’s it for this week! If you have a story idea, please feel free to reach out to me at press@promotivemedia.ca and be sure to check out the stories in full at our website biotechnologyfocus.ca. Until next time, from my desk to yours – this is Michelle Currie.