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Clinical Pharmacology

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CAMBRIDGE, Mass., June 01, 2017 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the appointment of Santiago Arroyo, M.D., Ph.D. as Chief Medical Officer and Senior Vice President, Development. “Santiago’s deep understanding of successful clinical development coupled with his experience as a principal investigator on many trials, will be a huge asset to our expanding pipeline of biosimilars and novel drugs for autoimmune diseases. I am delighted to welcome him to our team,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. Dr. Arroyo joins Momenta from Boston Pharmaceuticals, where he was Chief Medical Officer. Previously he was Senior Vice President, Head of Clinical Research and Chief Medical Officer of Biotherapeutics and Pharmatherapeutics at Pfizer Inc. in the areas of Cardiovascular and Metabolism, Pain, Neuroscience, Regenerative Medicine and Rare Diseases. He was previously Therapeutic Area Head for Neurosciences, Discovery Medicine and Clinical Pharmacology at Bristol-Myers Squibb and Neurology Global Therapeutic Area Head for Eisai Global Clinical Development. Dr. Arroyo was an Instructor in Neurology at the Johns Hopkins Hospital and helped set up and run the epilepsy programs at the Medical College of Wisconsin and Hospital Clinic of Barcelona, Spain. Dr. Arroyo received his medical degree from the Autonomous University of Madrid and his Ph.D. from the University of Barcelona, Spain. “This is an exciting time at Momenta as the pipeline is both growing and advancing rapidly. We expect multiple data readouts across the biosimilar and novel programs this year,” said Dr. Arroyo. “Momenta’s understanding of innovative science and efficient clinical development is extremely compelling and I look forward to contributing to the development of products that will change the lives of patients.” Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for autoimmune indications. To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release. The company’s logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners. Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the Company’s pipeline; Dr. Arroyo’s expected impact on the Company’s pipeline; and the timing of clinical trial results.  Forward-looking statements may be identified by words such as “believe,” “continue,” “could,” “expect,” “guidance,” “may,” “plan,” “potential,” “target,” “will” and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, including those referred to under the section “Risk Factors” in the Company's Quarterly Report on Form 10-Q for the year ended March 31, 2017, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


CHICAGO--(BUSINESS WIRE)--Viviphi Ltd (Greenwood Village, CO) announced the appointment of Dr. Howard McLeod to the position of Senior Research Advisor in Precision Medicine. McLeod will also join the Viviphi Precision Medicine Clinical Advisory Board. He is well known to the Precision Medicine community given his leadership responsibilities for the Department of Individualized Cancer Management at the H. Lee Moffitt Cancer Center in Tampa Bay, Florida. McLeod is an endowed Research Chair in the State of Florida and a Professor at the University of South Florida. He is also a 1000 Talent Scholar in China and has served on the FDA committee on Clinical Pharmacology and the NIH Human Genome Advisory Council. He is vice chair for Pharmacogenomics for NCI ALLIANCE clinical trials group, overseeing the largest oncology pharmacogenomics portfolio in the world. As an active entrepreneur, he serves on the Board of Directors, Scientific Advisory Board, and as a domain expert consultant to publicly traded and privately held companies. He has also founded both for-profit and non-profit companies in the USA and China and has published over 500 peer reviewed papers on pharmacogenomics, applied therapeutics, or clinical pharmacology and continues to work to advance individualized medicine. In his role with Viviphi, Dr. McLeod will assist in translating research and clinical advances in precision medicine in oncology. He will help to drive the Viviphi™ technology roadmap and will function as an active ambassador of the Company and the PrecisionPlan™ cognitive computing platform at national and international research and clinical symposia. Gerry Hogue, President and CEO of Viviphi, highlighted Dr. McLeod’s contributions to precision medicine in oncology and the opportunity to work with Dr. McLeod to generate codified clinical rules that put world-leading cancer knowledge at the fingertips of patients and oncologists. “We are extremely pleased to have Dr. Howard McLeod join Viviphi’s Precision Medicine Advisory Board. His depth of knowledge and leadership in genomic-guided therapies, and his commitment to improving point-of-care decision-making and patient outcomes is widely known and respected.” Dr. McLeod shared his enthusiasm with joining the advisory board: “There are practical challenges for oncologists to deliver precision medicine, from the high pace of new research to the lack of access to practical tools to turn the advances into treatment to help their patients. I’m very excited by the opportunity to provide Viviphi advice as it advances its platform to address these concerns by providing curated and codified world-leading knowledge to support clinical decisions in standard of care and genomic-guided treatments.” Viviphi is now actively promoting the benefits of PrecisionPlan™ and attracting significant interest from leading NCI Centers, large and high performing community health systems, private practice clinicians, professional cancer care organizations, pharmaceutical companies, patient advocacy groups and others in the space. Viviphi is a leading provider of precision medicine solutions for cancer therapy. Using gathered data from electronic medical records and lab systems combined with patient-specific genomic information, the PrecisionPlan™ cognitive computing platform generates comprehensive, actionable and patient-specific treatment plans to accelerate clinical decision making and advance cancer care. Viviphi also offers a patient app, GenomePlan™, currently available in the Apple App Store and via an online patient portal, to help cancer patients learn more about their treatment options and to help guide discussions with physicians. Viviphi is headquartered in Greenwood Village, Colorado. To learn more, visit www.viviphicare.com


CAMBRIDGE, Mass., June 01, 2017 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the appointment of Santiago Arroyo, M.D., Ph.D. as Chief Medical Officer and Senior Vice President, Development. “Santiago’s deep understanding of successful clinical development coupled with his experience as a principal investigator on many trials, will be a huge asset to our expanding pipeline of biosimilars and novel drugs for autoimmune diseases. I am delighted to welcome him to our team,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. Dr. Arroyo joins Momenta from Boston Pharmaceuticals, where he was Chief Medical Officer. Previously he was Senior Vice President, Head of Clinical Research and Chief Medical Officer of Biotherapeutics and Pharmatherapeutics at Pfizer Inc. in the areas of Cardiovascular and Metabolism, Pain, Neuroscience, Regenerative Medicine and Rare Diseases. He was previously Therapeutic Area Head for Neurosciences, Discovery Medicine and Clinical Pharmacology at Bristol-Myers Squibb and Neurology Global Therapeutic Area Head for Eisai Global Clinical Development. Dr. Arroyo was an Instructor in Neurology at the Johns Hopkins Hospital and helped set up and run the epilepsy programs at the Medical College of Wisconsin and Hospital Clinic of Barcelona, Spain. Dr. Arroyo received his medical degree from the Autonomous University of Madrid and his Ph.D. from the University of Barcelona, Spain. “This is an exciting time at Momenta as the pipeline is both growing and advancing rapidly. We expect multiple data readouts across the biosimilar and novel programs this year,” said Dr. Arroyo. “Momenta’s understanding of innovative science and efficient clinical development is extremely compelling and I look forward to contributing to the development of products that will change the lives of patients.” Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for autoimmune indications. To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release. The company’s logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners. Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the Company’s pipeline; Dr. Arroyo’s expected impact on the Company’s pipeline; and the timing of clinical trial results.  Forward-looking statements may be identified by words such as “believe,” “continue,” “could,” “expect,” “guidance,” “may,” “plan,” “potential,” “target,” “will” and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, including those referred to under the section “Risk Factors” in the Company's Quarterly Report on Form 10-Q for the year ended March 31, 2017, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that it is partnering with Phase I Unit, Peking Union Medical College (PUMC) Hospital’s Clinical Pharmacology Research Center (PUMCH-CPRC) in Beijing to help Chinese pharmaceutical companies enhance their drug development processes. Phase I Unit at PUMCH-CPRC will employ Certara’s Simcyp® Population-based Simulator to develop physiologically-based pharmacokinetic (PBPK) models in support of Chinese new and generic drug applications to the Chinese Food and Drug Administration (CFDA). “We are proud to support China’s efforts to foster healthcare innovation. By increasing its adoption of PBPK modeling and simulation, it will expedite its pharmaceutical companies’ drug development processes and regulatory submissions, whilst also helping to bring safer therapies to market,” said Simcyp President and Managing Director Dr. Stephen Toon. “An increasing number of Chinese pharmaceutical companies want to use PBPK modeling and simulation as part of their drug development plans. We felt that the best way to maintain Certara’s high scientific standards for these Chinese customers and help circumvent some of the language-related commercial impediments was to partner with Phase I Unit at PUMCH-CPRC, which is one of the most prestigious academic pharmaceutical research institutions in China,” added Dr. Toon. “We are delighted to expand our partnership with Certara and be able to provide Chinese pharmaceutical companies with modeling and simulation consulting support to strengthen their regulatory submissions,” said Professor Pei Hu, MD, professor and director of Phase I Unit at PUMCH-CPRC. Certara and Phase I Unit at PUMCH-CPRC already have a great partnership track record. The two organizations have been working together for several years to increase PBPK modeling and simulation education and training in China and have co-hosted several national workshops. Phase I Unit at PUMCH-CPRC uses Certara’s modeling and simulation technology for first-in-human, point-of-care, and late-phase clinical trials. It has many years’ experience using both Certara’s Simcyp Simulator and Phoenix® software and has published numerous peer-reviewed papers based on research conducted using those platforms. Phase I Unit at PUMCH-CPRC is a Phoenix Center of Excellence. CFDA also employs Certara’s Phoenix software and is a regulatory affiliate member of the Simcyp Consortium. PUMC Hospital, which was founded by the Rockefeller Foundation in 1921, conducts clinical research into severe, rare and complicated diseases. It has 4,000 employees and is affiliated with both PUMC and the Chinese Academy of Medical Sciences. Certara’s Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating new drug formulations, and predicting drug-drug interactions and PK outcomes in clinical populations. These include vulnerable populations such as pediatric patients, pregnant women, and patients with impaired organ function. Phoenix is the most advanced, intuitive, and widely-used software for PK, pharmacodynamic, and toxicokinetic modeling and simulation. Through this new partnership with PUMC Hospital, Certara is providing Chinese customers with access to its modeling and simulation technology and helping accelerate safer and more effective drug development in China. Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.


SAN CARLOS, Calif.--(BUSINESS WIRE)--In recent years, stroke incidence and hospitalizations have increased more than 40 percent among younger individuals from 25 to 44 years of age1. Highlighting the growing impact of stroke on young adults and adolescents during Stroke Awareness Month, the Lipoprotein(a) Foundation has issued an Infographic to raise awareness about stroke education. One in 5 people globally have inherited high Lipoprotein(a) - 63 million in the U.S.4 - and are at increased risk of heart disease and stroke. Additionally, the Foundation will be featured on TALK BUSINESS 360 TV on American Airlines during June and July 2017 featuring Justin, a Las Vegas-area high school football player who suffered a massive stroke at age 15. According to the National Stroke Association, 15 percent of ischemic strokes occur in young adults and adolescents, and as many as 40 percent of strokes in adolescents are unexplained. Young, healthy, active and fit, doctors determined that a genetic cholesterol condition led to Justin’s stroke - high levels of Lipoprotein(a), also known as Lp(a). Lp(a) is a strong, independent risk factor for coronary heart disease and stroke2,4. Unfortunately, for some people like Justin, the first sign of disease is a heart attack or stroke. When Justin collapsed, he was rushed to the local children’s hospital where he was kept sedated for five days. When he awoke he was completely paralyzed on his left side; he could not eat, drink, walk or move his left arm or hand. After a week in PICU, he was transferred to the in-patient rehab center where Justin began the work of learning to function again. Through hard work and determination, Justin was able to walk out of the rehab center three weeks later. Today, Justin is an active 17-year-old high school senior. Although he can no longer play football, he is an active member of his high school football team and attends all practices and games. For more information about patients with high Lp(a) and stroke, visit www.TESTLpa.org Recently published research continues to demonstrate the impact of elevated Lp(a) and its significance as an independent, genetic risk factor for early cardiovascular disease. The study “Lipoprotein (a) level, apolipoprotein (a) size, and risk of unexplained ischemic stroke in young and middle-aged adults" was recently published in Atherosclerosis, the International Journal for Research and Investigation on Atherosclerosis and Related Diseases (DOI: 10.1016/j.atherosclerosis.2016.08.013). According to researchers, the study underscores the importance of Lp(a) level as an independent risk factor for unexplained ischemic stroke, particularly in young and middle-aged white adults. Given the emergence of effective Lp(a)-lowering therapies, these findings support routine testing for Lp(a) in this setting, along with further research to assess the extent to which such therapies improve outcomes in this population.3 Lp(a) is currently the strongest monogenetic risk factor for coronary heart disease and aortic stenosis. 2,4 “Highly inheritable, if one parent had an ischemic stroke before 65, the children have 3 times the risk of suffering a stroke as well.5 A recent paper from Dr Goldenberg of Johns Hopkins Medicine also demonstrated that an ischemic stroke patient with high Lp(a) has a 10X greater risk of having a repeat stroke," said Patrick M. Moriarty, M.D., Professor of Medicine, Director of Clinical Pharmacology, Atherosclerosis and Lipoprotein Apheresis Center, Internal Medicine, University of Kansas Medical Center, Kansas.6 Lp(a) concentrations can be measured by a simple blood test and could be the first step in preventing up to 120,000 heart attacks and strokes every year;2,7 however, it is not included in most standard lipid panel tests that check cholesterol levels.1 “There is a growing body of research that links high Lp(a) to heart attacks and strokes. Unfortunately, for people like Justin, the first sign of a problem is when they have a stroke or heart attack. We are proud to support education and awareness of unexplained stroke, particularly in adolescents and young adults like Justin and will continue to empower patients and prevent cardiovascular events and death due to high Lipoprotein(a) through proper testing and diagnosis,” said Sandra Revill Tremulis, founder of Lipoprotein(a) Foundation. Because approximately 63 million Americans have high Lipoprotein(a) and are at risk of premature cardiovascular disease, the vision for the foundation is: To live in a world where high Lipoprotein(a) is routinely diagnosed, treated and family screened. The mission is to prevent cardiovascular events and death due to high Lipoprotein(a) by diagnosing this inherited risk for cardiovascular disease; educating and empowering patients and saving lives. Our goal is to save lives by increasing awareness, advocating for routine testing, and supporting research that will lead to a specific treatment for elevated Lipoprotein(a). Based in San Carlos, California, the Lipoprotein(a) Foundation is a patient-founded, 501(c)3 non-profit organization. Learn more about stroke and high Lp(a) visit: www.TESTLpa.org


CAMBRIDGE, Mass., June 01, 2017 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the appointment of Santiago Arroyo, M.D., Ph.D. as Chief Medical Officer and Senior Vice President, Development. “Santiago’s deep understanding of successful clinical development coupled with his experience as a principal investigator on many trials, will be a huge asset to our expanding pipeline of biosimilars and novel drugs for autoimmune diseases. I am delighted to welcome him to our team,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. Dr. Arroyo joins Momenta from Boston Pharmaceuticals, where he was Chief Medical Officer. Previously he was Senior Vice President, Head of Clinical Research and Chief Medical Officer of Biotherapeutics and Pharmatherapeutics at Pfizer Inc. in the areas of Cardiovascular and Metabolism, Pain, Neuroscience, Regenerative Medicine and Rare Diseases. He was previously Therapeutic Area Head for Neurosciences, Discovery Medicine and Clinical Pharmacology at Bristol-Myers Squibb and Neurology Global Therapeutic Area Head for Eisai Global Clinical Development. Dr. Arroyo was an Instructor in Neurology at the Johns Hopkins Hospital and helped set up and run the epilepsy programs at the Medical College of Wisconsin and Hospital Clinic of Barcelona, Spain. Dr. Arroyo received his medical degree from the Autonomous University of Madrid and his Ph.D. from the University of Barcelona, Spain. “This is an exciting time at Momenta as the pipeline is both growing and advancing rapidly. We expect multiple data readouts across the biosimilar and novel programs this year,” said Dr. Arroyo. “Momenta’s understanding of innovative science and efficient clinical development is extremely compelling and I look forward to contributing to the development of products that will change the lives of patients.” Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for autoimmune indications. To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release. The company’s logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners. Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the Company’s pipeline; Dr. Arroyo’s expected impact on the Company’s pipeline; and the timing of clinical trial results.  Forward-looking statements may be identified by words such as “believe,” “continue,” “could,” “expect,” “guidance,” “may,” “plan,” “potential,” “target,” “will” and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, including those referred to under the section “Risk Factors” in the Company's Quarterly Report on Form 10-Q for the year ended March 31, 2017, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


News Article | June 1, 2017
Site: www.eurekalert.org

The University of Liverpool and Radboud University, Nijmegen have launched a new website intended to promote safer prescribing and improve quality of care for cancer patients called http://www. . Building on comparable, world-renowned resources for HIV and Hepatitis, the website will host an easy-to-use, interaction checker, enabling rapid screening for drug-drug interactions (DDIs) with anti-cancer agents. Users will be able to select from a list of anti-cancer agents -- organised by generic name, trade name and indication -- and a comprehensive list of commonly prescribed co-medications and see, at a glance, whether a DDI between selected drugs is likely. The rationale and quality of evidence behind each recommendation will also be clearly displayed. The team plans to produce a living, comprehensive resource -- hosting up to 200 anti-cancer agents used to treat both solid and haematological cancers -- which will be rolled out over the next three to five years. DDIs are a vital consideration for patients undergoing cancer therapy and the health professionals treating them. Cancer patients are at significant risk of DDIs since they can often be prescribed multiple drugs as part of their anti-cancer therapy regimen, in order to manage the side effects of therapy and, increasingly, in order to manage additional comorbidities. They may also use complementary and alternative medicines. This new resource will address this challenge by improving DDI education and empowering Health Care Professionals to manage DDIs more effectively. Saye Khoo, Professor of Clinical Pharmacology at the University of Liverpool's Institute of Translational Medicine, co-founder of sister sites HIV and Hepatitis Drug Interactions and member of the Cancer Drug Interactions editorial team, said: "This site harnesses the methodology of Liverpool's leading Drug Interactions resources and applies it to cancer: an area in great need of improved DDI management. We are delighted to be working with Radboud colleagues on this exciting project." Dr Nielka van Erp, Hospital Pharmacist and Clinical Pharmacologist at and co-Clinical Lead for project, said: "We have been developing the site since January 2017 and are very excited to share our progress with cancer healthcare professionals. "Our aim is that the site will become integral to cancer drug prescribing, and we hope we have developed something of real clinical utility, which will improve the safe use of medication for cancer patients internationally" Following this launch the team will be inviting feedback and welcomes any views and comments. Please contact k.mcallister@liv.ac.uk to share your views or if you'd like to be added to the website's mailing list.


A new study suggests that to optimize neuroprotection and prevent cerebral palsy in extremely preterm infants, women should receive magnesium sulfate to obtain a blood level between 3.7 and 4.4 mg/dL at the time of delivery. The study included 636 women who received magnesium sulfate and 1269 who received placebo. The findings are important because magnesium sulfate is indicated for neuroprotection of preterm fetuses; however, the optimal dosing schedule to prevent cerebral palsy is not known. "Women have traditionally received a standard dose of magnesium sulfate to prevent cerebral palsy in the extremely preterm fetus, but this study is the first to use pharmacokinetic modeling to suggest a therapeutic target maternal serum level we should aim for," said Dr. Kathleen Brookfield, lead author of the Journal of Clinical Pharmacology study. "The dose of magnesium sulfate can now be tailored depending on maternal factors and the clinical situation to achieve this target."


News Article | June 7, 2017
Site: www.eurekalert.org

A new analysis suggests that among older adults who take cardiovascular medications, those using non-selective beta-blockers may be at an increased of falling compared with those using selective beta-blockers. These types of drugs are already known to differ by their receptor binding properties and their systemic effects on the body. In the analysis of data from 2 prospective studies involving more than 10,000 individuals, use of a selective beta-blocker was not associated with fall risk, but use of a non-selective beta-blocker was associated with a 22% increased risk. In total, 2,917 participants encountered a fall during follow-up. The results indicate that fall risk should be considered when weighing the pros and cons of prescribing different beta-blocker classes for older individuals. "Drug-related falls remain under-recognized, leading to preventable falls and related injury. Precise prediction of drug-related fall risk is of major importance for clinical decision-making," said Dr. Nathalie van der Velde, senior author of the British Journal of Clinical Pharmacology study. "Knowledge of type-specific effects such as selectivity in beta-blockers can be expected to improve decision-making."


A vaccine to immunize people against high levels of cholesterol and the narrowing of the arteries caused by build-up of fatty material (atherosclerosis) may be possible following successful results in mice. Now, a phase I trial in patients has started to see if the findings translate to humans. The study, which is published in the European Heart Journal, is the first to show that it is possible to immunize genetically modified mice with a molecule that causes the body to produce antibodies against an enzyme called PCSK9 (Proprotein covertase subtilisin/kexin type 9), which plays a role in preventing the clearance of low density lipoprotein cholesterol ("bad" cholesterol) from the blood. People with high levels of LDL cholesterol, either due to their genetic inheritance, or to poor diet and lifestyles, are at much greater risk of developing cardiovascular disease prematurely. These diseases of the heart and blood vessels, caused by atherosclerosis, have overtaken infections as the main cause of illness and death throughout the world. At present, drugs such as statins can be used to lower LDL cholesterol, but they have to be taken on a daily basis and although they are generally well-tolerated they can cause adverse side effects in some people. The most recently approved cholesterol-lowering compounds are monoclonal antibodies targeting PCSK9, which are highly effective, but their effect is short-lived, resulting in frequent re-application and high costs. The research published today shows that the AT04A vaccine, when injected under the skin in mice that have been fed fatty, Western-style food in order to induce high cholesterol and the development of atherosclerosis, reduced the total amount of cholesterol by 53%, shrank atherosclerotic damage to blood vessels by 64%, and reduced biological markers of blood vessel inflammation by 21-28%, compared to unvaccinated mice. Furthermore, the induced antibodies remained functional over the whole study period and concentrations were still high at the end of the study. Dr Günther Staffler, chief technology officer at AFFiRis (the company that developed AT04A) and one of the authors of the study, said: "AT04A was able to induce antibodies that specifically targeted the enzyme PCSK9 throughout the study period in the circulation of the treated mice. As a consequence, levels of cholesterol were reduced in a consistent and long-lasting way, resulting in a reduction of fatty deposits in the arteries and atherosclerotic damage, as well as reduced arterial wall inflammation. "The reduction in total cholesterol levels was significantly correlated with induced antibody concentration, proving that induced antibodies caused the reduction in cholesterol and also are ultimately responsible for the reduction of atherosclerosis development. As antibody concentrations remained high at the end of the study, it can be assumed they would continue to reduce cholesterol levels for some time afterwards, resulting in a long-lasting effect, as has been shown in previous studies. "If these findings translate successfully into humans, this could mean that, as the induced antibodies persist for months after a vaccination, we could develop a long-lasting therapy that, after the first vaccination, just needs an annual booster. This would result in an effective and more convenient treatment for patients, as well as higher patient compliance." The enzyme PCSK9 is made in the liver and it locks on to LDL cholesterol receptors, reducing their ability to get rid of LDL cholesterol from the blood. When injected, AT04A causes the body to produce antibodies that block the function of PCSK9, so that the activity of the LDL cholesterol receptors is increased. "The way that AT04A is administered is comparable to a vaccine," explained Dr Staffler. "However, the difference between a conventional vaccine and our approach is that a vaccine induces antibodies that are specific to bacterial or viral proteins that are foreign to the body -- pathogens -- whereas AT04A induces antibodies against a target protein that is produced by the body -- endogenous proteins. This it is really an immunotherapeutic approach rather than a vaccine approach." In 2015, a phase I clinical study started at the Department of Clinical Pharmacology, Medical University of Vienna, Austria, studying AT04A and another molecule AT06A in 72 healthy people to assess its safety and activity. The study is expected to complete at the end of this year. In an accompanying editorial, Professor Ulrich Laufs, of Saarland University, Germany, and Professor Brian Ference, of the University of Bristol, UK, and the Wayne State University School of Medicine, Detroit, USA, write: "It appears promising to further evaluate long-term LDL cholesterol lowering by vaccination against PCSK9 for the prevention of atherosclerotic events." However, they say that "safety, the response in humans and the very important but unknown long-term immune effects need to be very carefully addressed during the course of clinical development." In particular, reductions in total cholesterol via statins and other drugs are associated with an increase in new onset diabetes. "Therefore, one potential safety concern for long-term lowering of LDL cholesterol with a vaccine directed against PCSK9 is the potential for an increased risk of new onset diabetes. In the short term, the LDL cholesterol lowering effect of statins and PCS9 inhibitors appears to far outweigh the risks of new onset diabetes."

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