News Article | April 17, 2017
The most common cause for the narrowing of the carotid artery is atherosclerosis, where so-called plaques build up on the vessel walls. If a plaque ruptures, blood clots can form that either further occlude the site that is already narrowed, or are carried away by the blood flow, which could lead to vascular occlusion at a different site. If this happens in the carotid artery, it could lead to a stroke. How easily a plaque ruptures depends on how thick the tissue layer surrounding its core is. The thicker this so-called fibrous cap, the more stable and therefore more harmless the vessel deposit. "New imaging procedures enable us to detect dangerous plaques with increasing precision; but the therapies currently available for removing these unstable plaques and thus preventing a stroke entail a certain amount of risk that the plaques will rupture during the procedure", explains Lars Mägdefessel. "This is why these therapies are not used on individuals with a narrowed carotid artery who have so far not experienced any symptoms." Traditionally, physicians try to reduce the size of the deposits in the vessels in order to widen the narrowed sites. "For narrowed carotid arteries, though, the notion of stabilising the plaques is becoming ever more prevalent. Unlike in the coronary vessels, in the carotid artery plaques rupturing is more dangerous than the narrowing", says Mägdefessel. Mägdefessel and his team compared material from patients with stable and unstable deposits in the carotid artery. They particularly focused on microRNAs. These molecules are involved in the gene regulation in about 60 percent of mammals' genes. They can prevent gene information that has already been read from being translated into proteins, and have become a focus of biomedical research as active ingredients and starting points for new therapies in recent years. The scientists discovered that microRNA-210 was reduced the most in the blood samples of patients with unstable plaques. These were blood samples that were obtained locally near the vessel deposits. Further examinations showed that microRNA-210 is primarily present in the fibrous caps of plaques and that it inhibits the expression of the APC gene. As a consequence, fewer smooth muscle cells die in the fibrous cap and it becomes more stable. Moreover, the animal model could show that fewer plaques rupture when microRNA-210 is administered. The scientists are currently researching how microRNA-210 can be applied locally. The risk of adverse events in other organs is much too high if microRNA modulators are administered systemically. The main concern with microRNA-210 is that tumour cells that are possibly already in existence will multiply, because the expression of APC is inhibited. This is because APC is a tumor suppressor gene which inhibits the growth of cancers in the healthy body. In order to avoid such so-called off-target effects, the researchers are currently testing coated stents or balloons that are inserted directly into the carotid artery in pigs. "For this step, we also rely on the collaboration with companies that, for example, develop soft balloons that cause little friction and thus make the procedure safer", says Mägdefessel. "Only thus will our results reach patients as effective therapies." S.M. Eken, H. Jin, E. Chernogubova, Y. Li, N. Simon, C. Sun, G. Korzunowicz, A. Busch, A. Bäcklund, C. Österholm, A. Razuvaev, T. Renné, H.-H. Eckstein, J. Pelisek, P. Eriksson, M. Gonzalez Diez, L. P. Matic Perisic, I. N. Schellinger, U. Raaz, N. J. Leeper, G. K. Hansson, G. Paulsson-Berne, U. Hedin, L. Maegdefessel. "MicroRNA-210 Enhances Fibrous Cap Stability in Advanced Atherosclerotic Lesions". Circulation Research. 2017 Feb 17;120(4):633-644. DOI: 10.1161/CIRCRESAHA.116.309318. The most important goal of the German Centre for Cardiovascular Research (DZHK) is that new knowledge gained from cardiovascular research reaches patients as rapidly as possible. The diagnosis, prevention and treatment of cardiovascular diseases in Germany shall thus be improved. In order to reach this goal, basic researchers and clinical researchers from 30 institutions at 7 sites are working together in the DZHK. Moreover, the DZHK enables young scientists to enrich translational research in the DZHK with their knowledge with a series of measures. DZHK junior scientist groups are an instrument for which researchers from all over the world can submit an application to head them. The groups are sponsored for a maximum of 5 years with up to 250,000 euros per year; therefore, with up to 1.25 million euros in total. The DZHK was founded in 2011 upon the initiative of the German Federal Ministry of Education and Research (BMBF) and is 90 percent funded by the Federal Government and 10 percent by the governments of those German federal states in which its member institutions are headquartered. It is among the six German Centres for Health Research (Deutsche Zentren der Gesundheitsforschung, DZG) that are dedicated to the investigation of widespread diseases. Website: http://www.
News Article | November 1, 2016
WASHINGTON - November 1, 2016 - Patients with severe aortic stenosis (AS) at intermediate surgical risk, and who are treated with transcatheter aortic valve replacement (TAVR) had improved health status at one month compared with surgical aortic valve replacement (SAVR) but two-year quality of life outcomes were similar. Prior studies have shown that TAVR results in an early quality of life (QoL) benefit in patients at high surgical risk; however, the effect of TAVR versus. SAVR on QoL in intermediate risk patients was unknown prior to this study. Findings from the PARTNER II QUALITY OF LIFE study were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. Between 2011 and 2013, 2,032 intermediate risk patients with severe AS were randomized to TAVR with the SAPIEN XT valve (n=1,011) or SAVR (n=1,021) in the PARTNER II Trial. Quality of life was assessed on all patients at baseline, one, 12 and 24 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-36 and EQ-5D. The study found that at two year follow-up, both TAVR and SAVR were associated with clinically and statistically significant improvements in disease-specific and generic QoL measures as compared with baseline. The two year change in KCCQ Overall Summary Score was 19.2 points with TAVR compared with 18.3 points for SAVR. Similarly, the two year change in the SF-36 Physical Component Summary Score was 3.0 points with TAVR versus 2.7 points with SAVR. In contrast, at one month, TAVR was associated with significantly better QoL than SAVR, but this difference was restricted to patients who were treated via transfemoral (TF) access and was not seen in patients that were treated via alternative (transapical or transaortic) access (p "This study shows that among intermediate risk patients with severe AS, quality of life improved significantly and to a similar extent with TAVR and SAVR through two years. However, transfemoral (but not transthoracic) TAVR was associated with a substantial and clinically important early health status benefit compared with SAVR.," said lead investigator David J. Cohen, MD, MSc Director of Cardiovascular Research at Saint Luke's Mid America Heart Institute in Kansas City, MO. "We believe that these early differences in quality of life may be important to many patients who are suitable candidates for both procedures. Longer term follow up is needed to assess the durability of quality of life improvement with TAVR versus SAVR in this intermediate risk population." The PARTNER II trial was funded by Edwards Lifesciences. Dr. Cohen reports research grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific, and consulting income from Medtronic and Abbott Vascular. The results of the PARTNER II QUALITY OF LIFE trial will be presented on Tuesday, November 1 at 9:20 AM ET in the Main Arena (Ballroom, Level 3) of the Walter E. Washington Convention Center. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .
News Article | November 7, 2016
NE PAS DISTRIBUER AUX AGENCES DE PRESSE AMÉRICAINES NI DIFFUSER AUX ÉTATS-UNIS Dr André P. Boulet,PhD., Président, directeur général et Président du Conseil d'Administration de Groupe Santé Devonian Inc,, une société pharmaceutique basée au Québec, Canada et Benoit Chotard, président de Capital Orletto inc. (ou la "Société") (TSX-V "OLE.P") qui vont proposer à leurs actionnaires d'amalgamer, à des assemblées d'actionnaires tenues respectivement le 8 novembre 2016 et le 25 novembre 2016 pour former une nouvelle entité appelée Groupe Santé Dévonian inc/ Devonian Health Group inc ("Devonian"), sont heureux d'annoncer la nomination du Dr Jean-Claude Tardif, CM, MD, FRCPC, FACC, FCCS, FAHA, FESC, FCAHS comme président du Comité Scientifique Consultatif ("CSC") de Devonian, qui servira de ressource stratégique à Devonian pour son programme clinique. "Nous sommes ravis d'avoir le Dr Tardif en tant que Président du Comité Consultatif Scientifique de Devonian. Dr Tardif a une expertise considérable dans la découverte et le développement de médicaments qui nous sera utile dans l'élaboration de l'orientation stratégique de Devonian. Nous avons hâte d'obtenir les conseils du Dr Tardif sur l'évaluation des diverses possibilités scientifiques et cliniques ainsi que sur le programme clinique en cours. Nous prévoyons accroitre le nombre de membres du CSC pour inclure des leaders d'opinion de renommée mondiale dans les maladies inflammatoires/auto-immunes qui vont jouer un rôle clé dans les initiatives de développement scientifique et clinique," a déclaré le Dr André P. Boulet, Ph.D., Président, directeur général et Président du Conseil d'Administration de Devonian. "Je suis très heureux de présider le Comité Scientifique Consultatif et de travailler avec l'équipe de Devonian à l'avancement des programmes thérapeutiques. Devonian adopte une approche unique et passionnante qui pourrait apporter de nouvelles thérapies sur le marché de manière plus efficace, en ciblant les domaines où les besoins médicaux ne sont pas encore satisfaits. Je suis heureux d'appuyer l'équipe dans leurs efforts pour amener ces traitements novateurs sur le marché", a déclaré le Dr Jean-Claude Tardif, président du Comité Scientifique Consultatif de Devonian. Jean-Claude Tardif est directeur du centre de recherche de l'Institut de Cardiologie de Montréal et professeur de médecine à l'Université de Montréal. Il a obtenu son doctorat en médecine en 1987 à l'Université de Montréal et s'est perfectionné en cardiologie et en recherche à Montréal et à Boston jusqu'en 1994. Dr. Tardif est titulaire de la Chaire de Recherche du Canada en médecine personnalisée et de la chaire de recherche dotée en athérosclérose de l'Université de Montréal. Il est directeur scientifique du Centre de coordination des innovations en santé de Montréal (MHICC) et président du comité directeur du réseau pancanadien d'imagerie de l'athérosclérose (CAIN) et du Réseau d'essais cliniques en imagerie médicale du Canada (MITNEC), lesquels sont financés par les IRSC. Le Dr Tardif est l'auteur et co-auteur de plus de 800 articles et résumés dans des revues scientifiques, y compris le New England Journal of Medicine, le Journal of the American Medical Association, The Lancet, Circulation, le Journal de l'American College of Cardiology, le European Heart Journal, Nature Genetics, Genes and Development, le British Journal of Pharmacology, et Cardiovascular Research. De plus, il a écrit plus de 30 chapitres de livre (y compris dans le manuel des maladies cardiaques Braunwald's) et a édité plusieurs livres. Il a donné quelque 400 conférences à travers le monde. Ses recherches portent sur les aspects génomiques et moléculaires de l'athérosclérose et autres maladies connexes. Elles utilisent des modèles pré-cliniques et s'appuient sur des études cliniques mécanistiques et observationnelles de même que sur d'importants essais cliniques internationaux randomisés. Dr Tardif est, ou a été, le chercheur principal ou membre du comité directeur pour plusieurs grandes études cliniques internationales sur l'athérosclérose et d'autres maladies cardiovasculaires. Le Dr Tardif et son équipe ont créé le Centre de pharmacogénomique Beaulieu-Saucier de l'Institut de Cardiologie de Montréal et il a créé le Centre d'excellence en médecine personnalisée (CEPMed), celui-ci financé par le Réseau de centres d'excellence (RCE) du Canada et qui est aussi appuyé par plusieurs sociétés pharmaceutiques et biotechnologiques. Il est l'un des pères fondateurs de l'organisation internationale Partnership for Critical Markers of Disease (CMOD), qui met l'accent sur le développement et l'utilisation de biomarqueurs (www.cmod.org). Le Dr Tardif a remporté de nombreux prix au cours de sa carrière, dont le prix d'excellence en recherche de la Société canadienne de cardiologie, le prix Genesis de BIOquébec (pour sa contribution exceptionnelle aux sciences de la vie) et le Prix Armand-Frappier du gouvernement du Québec (la plus haute distinction scientifique au Québec). Il a également été nommé personnalité scientifique de l'année par le quotidien La Presse. En raison de ses réalisations, le Dr Tardif a été nommé Fellow de l'Académie Canadienne des Sciences de la Santé (FCAHS) et a récemment été intronisé à l'Ordre du Canada. Orletto est une Société de capital de démarrage créée conformément à la Politique 2.4 et, à ce jour, n'a mené aucune opération matérielle de toute nature, autre qu'identifier et évaluer les entreprises et les actifs en vue de réaliser une opération admissible. Le 9 septembre 2014, Orletto a réalisé son premier appel public à l'épargne et les actions ordinaires d'Orletto ont commencé à être transigées sur la Bourse. Depuis son incorporation, Orletto a engagé des frais dans l'exercice de son premier appel public à l'épargne, dans la recherche, l'évaluation et la négociation de potentielles opérations admissibles, et pour répondre aux obligations d'information imposées en tant qu'émetteur assujetti. Devonian est une société pharmaceutique botanique en stade avancé de développement qui emploie une stratégie novatrice ciblant des besoins médicaux non comblés. La principale stratégie de Devonian est de développer des médicaments sous ordonnance d'origine botanique. Cette stratégie est supportée par les directives réglementaires de l'agence réglementaire américaine (FDA) favorisant un développement plus efficace des médicaments botaniques comparativement à celui des médicaments sous ordonnance traditionnels. Devonian est fondée sur une vaste plate-forme technologique provenant de plus de dix années de recherche. Cette plateforme fournit un processus unique d'extraction, de purification, de stabilisation et de conditionnement du complexe moléculaire responsable de la photosynthèse des plantes et des algues : la Technologie Supra Moléculaire d'Extraction et Stabilisation (SUPREX). Le « Thykamine(MC) » est le premier produit dérivé de cette plate-forme. La puissance des activités anti-inflammatoire et anti-oxydative du « Thykamine(MC) » a été démontrée dans plusieurs études pré-cliniques ainsi que dans une étude clinique de phase 2a de « preuve de concept » chez des patients souffrant de colite ulcéreuse distale, de grade léger à modéré. Le produit progresse maintenant dans la phase des grandes études de phase 2 et ce, dans deux domaines thérapeutiques : la colite ulcéreuse et la dermatite atopique. Bien que la principale activité de Devonian soit le développement de médicaments botaniques, Devonian est également impliquée dans le développement de produits à valeur ajoutée en dermo-cosmétique dans le cadre d'une stratégie secondaire destinée à générer des revenus à court terme et optimiser l'efficacité du processus de fabrication. La Bourse de croissance TSX et son fournisseur de services de réglementation (au sens attribué à ce terme dans les politiques de la Bourse de croissance TSX) n'assument aucune responsabilité quant à la pertinence ou à l'exactitude du présent communiqué. Les énoncés contenus dans le présent communiqué de presse qui ne sont pas des faits historiques sont des énoncés prospectifs. Ces énoncés portent sur des événements et scénarios futurs et comportent donc des incertitudes et des risques inhérents. Les résultats obtenus pourraient différer de ceux projetés à l'heure actuelle. La Société n'assume aucune obligation de mettre à jour ces énoncés prospectifs.
News Article | February 20, 2017
ST. PAUL, Minn. & WASHINGTON--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today released 1-year results from its Coronary Orbital Atherectomy System Study (COAST) in a late-breaking presentation at the 2017 Cardiovascular Research Technologies (CRT) conference in Washington, D.C. The COAST study is CSI’s prospective, single-arm, multi-center, global IDE trial to evaluate the safety and efficacy of the company’s next-generation Micro Crown orbital atherectomy technology in treating patients with severely calcified coronary lesions. It follows the pivotal ORBIT II trial of the company’s Diamondback 360® Coronary OAS Classic Crown, which received PMA approval from the U.S. Food and Drug Administration (FDA) in 2013 as a primary treatment for severely calcified coronary arteries when facilitating stent delivery. CSI completed COAST enrollment of 100 patients, including 74 patients at 12 sites in the United States and 26 patients at five sites in Japan, in July 2015. Dr. Samin K. Sharma, Mount Sinai Medical Center, N.Y., presented the 1-year results including freedom from major adverse cardiac events (MACE), as well as target lesion revascularization (TLR) at one year after the procedure. Additional authors on the abstract are: Dr. Shigeru Saito, Shonan Kamakura General Hospital, Kamakura, Japan; Dr. Richard A. Shlofmitz of St. Francis Hospital in Roslyn, N.Y.; and Dr. Gregg Stone, Columbia University Medical Center, N.Y. “Incidence of severe coronary arterial calcium is significant and underappreciated,” said Dr. Sharma. “These 1-year results from the COAST IDE Study resulted in 77.8% freedom from 1-year MACE, therefore concluding that the Diamondback 360° Coronary OAS Micro Crown technology may address this unmet treatment need for this difficult to treat population.” Said Scott Ward, CSI chairman and chief executive officer, “We look forward to seeing how this 1-year COAST data will further impact the treatment of patients with severe coronary arterial calcium. It is important and necessary as we continue to seek device approval in the U.S. and Japan.” More information about the study design is available at www.ClinicalTrials.gov; identifier: NCT02132611. About Coronary Artery Disease (CAD) CAD is a life-threatening condition and a leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, significant arterial calcium is present in nearly 40% of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE). About Cardiovascular Systems, Inc. Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted the first 510(k) clearance for the use of the Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the Coronary Orbital Atherectomy System. To date, over 290,000 of CSI’s devices have been sold to leading institutions across the United States. The Coronary OAS Micro Crown is limited by federal law to investigational use and is currently not commercially available in the United States. For more information, visit the company’s website at www.csi360.com.
News Article | November 7, 2016
NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES M. André Boulet, President, CEO and Chairman of Devonian Health Group Inc a pharmaceutical company based in Québec Canada and Benoit Chotard, President of Orletto Capital inc. ("Orletto" or the "Corporation") (TSX VENTURE:OLE.P) who will propose to their shareholders to amalgamate at shareholder meetings to be held respectively on November 8, 2016 and November 25, 2016 to form a new entity called Groupe Santé Devonian Health Group Inc/Groupe Santé Devonian inc ("Devonian") are pleased to announce the appointment of Dr. Jean-Claude Tardif, CM, MD, FRCPC, FCCS, FACC, FAHA, FESC, FCAHS as Chairman of the Scientific Advisory Board ("SAB") of Devonian, which will serve as a strategic resource to Devonian as it advances its clinical program. "We are thrilled to have Dr. Tardif join Devonian as the Chairman of the Scientific Advisory Board. Dr Tardif has tremendous expertise in drug discovery and development, which we believe will be valuable in shaping the strategic direction of Devonian. We look forward to gaining counsel from Dr. Tardif on the assessment of various scientific and clinical opportunities as well as ongoing development of our clinical program. We plan to further expand our SAB to include renowned key opinion leaders in inflammatory / auto-immune diseases who will play a key role in Devonian's scientific and clinical development initiatives," said Dr. André P. Boulet, Ph.D., President, CEO and Chairman of Devonian. "I am very pleased to chair the Scientific Advisory Board and work with the Devonian team to advance Devonian's current and future therapeutic programs. Devonian is taking a unique and exciting approach that may bring new therapies to market in a more efficient manner, targeting areas of high unmet medical need. I am excited to support the team as they work to bring these innovative therapies to the market," stated Dr. Jean-Claude Tardif, Chairman of Devonian's Scientific Advisory Board. Jean-Claude Tardif is the Director of the Research Centre at the Montreal Heart Institute and Professor of Medicine at the University of Montreal. Dr. Tardif graduated from the University of Montreal with his medical degree in 1987 and completed his training in cardiology and research in Montreal and Boston in 1994. Dr. Tardif holds the Canada Research Chair in translational and personalized medicine and the University of Montreal endowed research chair in atherosclerosis. He is the Scientific Director of the Montreal Health Innovations Coordinating Centre (MHICC) and Chairman of the steering committees of the CIHR-funded Canadian Atherosclerosis Imaging Network (CAIN) and Medical Imaging Trials Network of Canada (MITNEC). Dr. Tardif has authored and co-authored more than 800 articles and abstracts in peer-reviewed publications, including the New England Journal of Medicine, the Journal of the American Medical Association, The Lancet, Circulation, the Journal of the American College of Cardiology, the European Heart Journal, Nature Genetics, Genes and Development, the British Journal of Pharmacology, and Cardiovascular Research. In addition, he has written more than 30 book chapters (including in Braunwald's Textbook of Heart Disease) and has edited several books. He has given approximately 400 invited lectures around the world. His research covers the molecular and genomic aspects of atherosclerosis and related diseases and also involves pre-clinical models, mechanistic and observational clinical studies as well as large international randomized clinical trials. Dr. Tardif is or has been the international principal investigator or part of the study leadership of several large clinical trials in the field of atherosclerosis and other cardiovascular diseases. Dr. Tardif and his team have created the Beaulieu-Saucier Pharmacogenomics Center at the Montreal Heart Institute and he has created the Center of Excellence in Personalized Medicine (CEPMed), the latter funded by the Network of Centers of Excellence (NCE) of Canada and which is also supported by multiple pharmaceutical and biotechnological companies. He is one of the founding fathers of the International Partnership for Critical Markers of Disease (CMOD) organization, which focuses on the development and better use of biomarkers (www.cmod.org). Dr. Tardif has won multiple awards during his career, including the Research Achievement Award of the Canadian Cardiovascular Society, the Genesis Award of BIOQuebec (for his outstanding contributions to life sciences) and the Armand-Frappier Award of the Government of Quebec (the highest scientific distinction in Quebec). He was also named scientific personality of the year by La Presse newspaper. Because of his accomplishments, Dr. Tardif was named Fellow of the Canadian Academy of Health Sciences (FCAHS) and was recently inducted into the Order of Canada. Orletto is a Capital Pool Company created pursuant to the Policy 2.4 and, to date, has not conducted material operations of any kind, other than to identify and evaluate businesses and assets with a view to completing a Qualifying Transaction. On September 9, 2014, Orletto completed its initial public offering, and the Orletto common shares commenced trading on the Exchange. Since incorporation, Orletto has incurred costs in carrying out its initial public offering, in seeking, evaluating and negotiating potential Qualifying Transactions, and in meeting the disclosure obligations imposed upon it as a reporting issuer. Devonian is a late stage botanical pharmaceutical company with novel therapeutic approaches targeting unmet medical needs. Devonian's core strategy is to develop prescription botanical drugs. This strategy is supported by US-FDA set of regulatory guidelines favouring a more efficient drug development pathway versus traditional prescription medicines. Devonian is based on a broad-based platform originating from over ten years of research. This platform provides a unique process of extraction, purification, stabilization and conditioning of a molecular complex responsible for the photosynthetic process in plants and algae: The Supra Molecular Complex Extraction and Stabilisation Technology (SUPREX). The "Thykamine(TM)" is the first product issued from this platform. The potent anti-inflammatory and anti-oxidative activities of "Thykamine(TM)" have been demonstrated in several pre-clinical experiments as well as in a Phase 2a "proof of concept" clinical study in patients with mild-to-moderate distal ulcerative colitis. The product is now moving into large phase 2 clinical trials in two therapeutic areas: Ulcerative Colitis and Atopic Dermatitis. While the development of prescription botanical drugs is its core business, Devonian is also involved in the development of high value derma-cosmeceutical products as part of a secondary strategy to generate short-term revenues and optimize manufacturing efficiency. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. The statements contained herein that are not historical facts are forward-looking statements. These statements address future events and conditions and so involve inherent risks and uncertainties. Actual results could differ from those currently projected. The Corporation does not assume the obligation to update any forward-looking statement.
News Article | December 21, 2016
According to the American Heart Association, approximately 2,200 Americans die each day from heart attacks, strokes and other cardiovascular diseases. The most common cause is blocked blood vessels that can no longer supply oxygen and nutrients to the heart and brain. A recent study by researchers at the University of Missouri School of Medicine has shown that a protein inhibitor drug prevents these blockages, and could be a new therapeutic approach to prevent heart attack, stroke and other diseases caused by blocked blood vessels. "Arteries are living hoses that narrow and enlarge in order to regulate blood flow to organs and muscles," said William Fay, M.D., the J.W. and Lois Winifred Stafford Distinguished Chair in Diabetes and Cardiovascular Research at the MU School of Medicine and senior author of the study. "Smooth muscle cells in the artery regulate blood flow by constricting and relaxing. However, when chronic inflammation occurs in a blood vessel - typically in response to diabetes, high cholesterol and cigarette smoking - the smooth muscle cells in the walls of arteries change their behavior. They gradually accumulate inside the artery and narrow the blood vessel. In the case of coronary arteries, which supply blood to heart muscle cells, this process produces blockages that can lead to a heart attack." Plasminogen activator inhibitor-1, or PAI-1, is a naturally occurring protein within blood vessels that controls cell migration. With diseases such as diabetes and obesity, PAI-1 over-accumulates in blood vessels. This promotes blockage formation. This process occurs not only in arteries, but also in vein grafts in patients who have undergone coronary artery bypass graft surgery. Fay's research team studied PAI-039, also known as tiplaxtinin, an investigational drug not yet used to treat humans. The researchers found that PAI-039 inhibited the migration of cultured human coronary artery smooth muscle cells, and prevented the development of blockages in arteries and bypass grafts in mice. "We found that PAI-039 decreased blockage formation by about 50 percent, which is a powerful effect in the models we used," said Fay, who also serves as a research scientist at the Harry S. Truman Memorial Veterans' Hospital in Columbia, Missouri. "In addition to reducing vascular blockages, inhibiting PAI-1 also produces a blood thinning effect that prevents the blood clots that trigger most heart attacks and strokes." Fay hopes that if future studies are successful, PAI-039 or similar drugs could be used to prevent blockages in arteries and bypass grafts. "I don't think there will be any one 'magic pill' that prevents arterial diseases, especially for those with other high-risk conditions," Fay said. "However, perhaps someday a PAI-1 inhibitor can be used in combination with other approaches such as proper diet and exercise, aspirin and cholesterol medications to prevent blood vessel blockages and reduce heart attack and stroke risk." The study, "Pharmacological Targeting of Plasminogen Activator Inhibitor-1 Decreases Vascular Smooth Muscle Cell Migration and Neointima Formation," recently was published in Arteriosclerosis, Thrombosis and Vascular Biology, a journal of the American Heart Association that focuses on blood vessel diseases. Research reported in this publication was supported by the National Institutes of Health (HL57346 and JL095951) and a Department of Veterans Affairs Merit Review Award (CARA-007-12S). The researchers have no conflicts of interest to declare related to this study. About the MU School of Medicine The MU School of Medicine has improved health, education and research in Missouri and beyond for more than 165 years. MU physicians treat patients from every county in the state, and more Missouri physicians received their medical degrees from MU than from any other university. For more information, visit http://medicine. .
News Article | November 2, 2016
Using specialized CT scans of a healthy heart and one with heart disease, a team of Johns Hopkins cardiologists and biomedical engineers say they've created computer models of the "shape" of blood flow through the heart's upper left chamber that someday may help predict stroke risk. Specifically, their computer visualizations found that blood in the diseased heart failed to flow in corkscrewlike "eddies" that most effectively moved blood out of the left atrium in the healthy heart and "showed us exactly how this motion would increase the risk of developing a blood clot," says http://www. , M.D., Ph.D., assistant professor of medicine and member of the Heart and Vascular Institute at the Johns Hopkins University School of Medicine. The researchers say the same fluid motion analysis used in their two-heart proof-of-concept study may one day offer an accurate way to predict stroke risk in people with heart disease marked by enlargement and weakness of the cardiac muscle. A description of the study and its results was published in the November print issue of Annals of Biomedical Engineering. "By looking at blood flow through the atrium, we think we can accurately assess stroke risk better than such risk factors as heart size and pumping strength," says Ashikaga. "Our study fills in a missing diagnostic link between heart function and fluid motion in our understanding of how each can affect stroke risk." Before this study, Ashikaga notes, researchers knew that enlargement of the heart, particularly the left upper chamber, was linked to increased stroke risk, particularly in people with atrial fibrillation, an irregular and often very rapid heart rate. Heart disease experts estimate that more than 1.6 million Americans each year are diagnosed with symptoms of atrial fibrillation that put them at risk for strokes caused by blood that pools in the heart and forms a clot, then travels to the brain. The new study, Ashikaga says, sheds significant light on just how an enlarged and "floppy" atrium led to blood clot formation. To collect the data needed to create the blood flow models, the Johns Hopkins team recruited two patients with a history of atrial fibrillation -- a 58-year-old woman with a healthy heart and a 68-year-old man with an enlarged heart. Each underwent a CT scan of their heart. Using the images, the researchers then computed the movement of blood flow as it entered the left atrium from the pulmonary veins, then passed through a valve into the left lower chamber, or ventricle. Finally, they fashioned a video representation of the fluid motion of the blood. In visualizing the healthy heart, the researchers saw that the blood flow formed into tight, corkscrewlike motions that circled around into doughnut formations, known as vortexes. The researchers say the vortexes helped move the blood efficiently through the atrium quicker and with less contact with the atrium's surface tissue. See blood flow modelled in a healthy heart here. The diseased heart they chose to examine was enlarged due to overuse, muscle fatigue and scarring, all of which can promote atrial fibrillation. In the enlarged heart, the researchers noticed that at the top of the atrium, the blood never fully forms the corkscrews that loop around into vortexes. Instead, by the time the blood reaches the bottom of the atrium, it seems to be falling in "sheets" that coat the surface of the heart. See blood flow through a diseased heart here. "As the blood comes in contact with the atrium's surface, it slows down due to shearing forces similar to friction, and this appears to prevent the blood from exiting the chamber as smoothly as it might," says Ashikaga. "The slower the blood moves and the more contact it has with the atrium, the more risk there is for a clot to form." Ashikaga says his team is currently conducting a larger long-term study looking at the blood flow of many more people with normal and ailing hearts, and monitoring the incidence of stroke and other signs of blood clots over time. He also hopes to develop the CT scan and computer analysis into a tool to predict stroke risk. According to the Centers for Disease Control and Prevention, an estimated 3 million to 6 million people have atrial fibrillation and nearly 800,000 people have strokes each year in the United States. The most common symptom of stroke is numbness or weakness on one side of the body. Physicians use CT scans of the brain, blood tests, EKGs, MRI scans or other imaging test to determine if a person has suffered from a stroke. Strokes may be treated with clot-busting drugs, blood thinners and sometimes surgery to remove the clot. Additional authors of the study include Tomohiro Otani, Abdullah Al-Issa, Amir Pourmorteza and Elliot McVeigh of Johns Hopkins Medicine, and Shigeo Wada of Osaka University. The research was funded by grants from the Japan Society for the Promotion of Science, Magic That Matters Fund for Cardiovascular Research and the Zegar Family Foundation.
News Article | December 13, 2016
New Study to Evaluate Transcatheter Aortic Valve Replacement in Low Risk Patients BALTIMORE, MD--(Marketwired - December 13, 2016) - MedStar Heart & Vascular Institute at MedStar Union Memorial Hospital is one of only 80 cardiac centers in the world, selected by the industry to participate in a study of an alternative treatment option for surgical aortic valve replacement. The study will evaluate the safety and effectiveness of the transcatheter approach to replacing the aortic valve, known as TAVR, in treating low risk patients with severe aortic stenosis. An estimated 2.5 million people over the age of 75, suffer with aortic stenosis, caused by calcium build-up in the aortic valve. The result is a narrowing in the valve which prevents it from opening and closing properly, forcing the heart to work harder to pump blood throughout the body. The reduced blood flow increases pressure within the heart, causing the heart to weaken and function poorly. "Replacing the aortic valve during open heart surgery has been a gold standard in treating aortic stenosis," said Dr. John Wang, chief of the cardiac catheterization laboratory at MedStar Union Memorial and scientific director for Baltimore Cardiovascular Research. "However, during a TAVR procedure, we can replace the diseased aortic valve using a catheter, through a small incision in the groin. The heart remains beating and the results have been excellent. The study will allow us to examine if this option is best for patients who are at a lower risk -- who could safely undergo the surgical replacement." MedStar Union Memorial Hospital is a regional leader in performing TAVR procedure, having done over 300 of these with stellar outcomes since it was first introduced in 2012. Presently, the technology is approved only for patients who are high or intermediate risk for the surgical replacement of their aortic valve. The study, which is supported by the MedStar Health Research Institute, will include up to 1256 patients and follow up for 5 years. Learn more about aortic stenosis and the trial, by visiting www.MedStarUnionMemorial.org.
News Article | February 15, 2017
Applied Therapeutics Inc., today announced the closing of its Series A financing round. The financing was led by Alexandria Venture Investments alongside E Squared Capital Management, Franklin Berger, ETP Global Fund and Syno Capital. Joel S. Marcus, Chairman, CEO and Founder of Alexandria Real Estate Equities (NYSE: ARE) and Alexandria Venture Investments, and industry expert, Franklin Berger, will join Les Funtleyder of E Squared Capital Management on the Board of Directors. Applied Therapeutics will use the proceeds of the Series A financing to pursue clinical development of technology licensed earlier this year from Columbia University. The technology, developed by Donald Landry, M.D., Ph.D., Chair of the Department of Medicine at Columbia University, targets enzymes implicated in metabolic and cardiovascular disease. “The Series A financing will allow us to advance our clinical programs in metabolic and cardiovascular disease,” said Shoshana Shendelman, Ph.D., Founder, Chairman and CEO of Applied Therapeutics. “We are excited to partner with Columbia University, our world-renowned clinical and scientific advisors, and our strategic investors to bring these important therapies one step closer to patients.” “As a clinician, I recognize the vital importance of developing drugs in areas of high unmet need with significant public health impact,” said Dr. Landry, an inventor of the technology and Chair of the Scientific Advisory Board. “We are excited to continue advancing our technology and look forward to working closely with Applied Therapeutics through this critical early phase of clinical development.” An experienced group of academics and industry stakeholders will join Dr. Landry on the Scientific Advisory Board, including Gregg Stone, M.D., Director of Cardiovascular Research at NY Presbyterian and Director of Research at the Cardiovascular Research Association, Lawrence Steinman M.D., Professor of Neurology at Stanford University, Roxana Mehran M.D., Director of Interventional Cardiology Research and Clinical Trials at Mt. Sinai School of Medicine, Roy Freeman M.D., Professor of Neurology at Harvard Medical School and Director of the Center for Autonomic and Peripheral Nerve Disorders at Beth Israel Deaconess Medical Center, and Andrew Wasmuth Ph.D., senior research scientist at Columbia. We are thrilled to partner with Dr. Shendelman, who herself is an alumna of Columbia University,” said Orin Herskowitz, Executive Director of Columbia Technology Ventures. “Applied Therapeutics is an example of how academic research, early-stage venture capital, and seasoned entrepreneurs can come together to address major public health problems. We look forward to continuing our work with Applied Therapeutics to the benefit of patients everywhere.” “Bringing together great science, an experienced management team, world-class clinical and scientific advisors and a strategic investor syndicate, Applied Therapeutics epitomizes the nature of potentially transformative early-stage opportunities we seek to invest in,” said Joel S. Marcus, Chairman, CEO and Founder of Alexandria Real Estate Equities and Alexandria Venture Investments. “We look forward to growing the company here in New York City and supporting its mission to bring life-saving, novel therapies to patients with metabolic and cardiovascular disease.” Applied Therapeutics is a privately held biotechnology company, focused on developing transformative drugs in areas of high unmet medical need – fatal or debilitating diseases for which no therapies are approved. The company applies cutting-edge technology to validated drug targets that have failed to produce meaningful therapies in the past. Applied Therapeutics believes that through innovative science, millions of lives can be saved. For more information, visit www.appliedtherapeutics.com.