News Article | May 5, 2017
A human muscle cell is growing on a fleece made from micrometer-thin polymer fibers. In this way, the synthetic membrane can be biologically camouflaged, which means that it looks like a normal blood vessel to the immune system. Credit: Swiss Federal Laboratories for Materials Science and Technology The textile and clothing industry has a long history in Switzerland. In order to remain competitive in the international market, the industry relies on innovations. The "SUBITEX – Sustainable Biomedicine Textiles" research initiative was set up by Empa and Swiss Textiles, the Swiss textile industry association, for this very purpose. Through innovative approaches and knowledge transfer, researchers and players in the industry are working tirelessly together to promote innovations in the field of biomedical textiles, and to bring them to the market more rapidly. Textiles are especially suitable for use on and in the human body. The body itself consists of many fibers too, including muscle, tendon and nerve fibers. Textiles can also be used to make copies of entire organs or parts of them. One current example of this is a major project involving Empa, called "Zurich Heart": under the aegis of the Zurich University Medicine initiative, in collaboration with the University Hospital, the University and ETH (Swiss Federal Institute of Technology) Zurich, Empa researchers are developing an artificial heart pump. This will include a fleece textile with a layer of heart muscle cells, which will not be detected by the blood as a foreign body. "We need to say goodbye to the idea that the development of textiles revolves around cotton T-shirts," says René Rossi, Subitex project manager and head of Empa's Biomimetic Membranes and Textiles lab. Instead, according to Rossi, their research is focused on a very wide range of ceramic, metal, wood, and synthetic fibers. "A textile is not just a cloth either, but rather a two-dimensional entity derived from a one-dimensional material: a fiber," he adds. The entities derived from this are flexible, malleable, stretchable, and light knitted, woven, or crocheted fabrics. Rossi continues: "Theoretically, there are no limits to textile materials or their properties." Many Swiss textile companies have also recognized this, successfully transforming themselves into specialist manufacturers of highly technical and high-quality products. They have networked more and more intensively with researchers and have skilfully occupied economic niches. Empa offers its services as a research partner precisely because it draws a line from basic research, as in the case of the "Zurich Heart" project, all the way to products that are close to the market. For example, it has developed optical fibers that are used in hospitals to measure the vital functions of premature babies, or as biosensors with pH-sensitive fibers to monitor wounds. Other examples of applications include textile pressure sensors that can be installed in wheelchairs, for instance, in order to show incorrect pressure loads; textile plasters that release medication in a targeted way; and a wettable chest strap that can be reliably used for long-term monitoring of electrocardiograms for cardiovascular patients. In order to promote further innovations and make even better use of the vast all-round potential of textiles, Empa and the Swiss industrial association, Swiss Textiles, established the "SUBITEX" research initiative two years ago. The development and use of innovative materials, fibers, fabrics and processes should assure Swiss textile companies a long-term competitive advantage in the global market. As part of this initiative, ten projects co-financed by the Commission for Technology and Innovation (KTI) have already been launched. Fifteen textile companies have now joined the initiative, including Flawa AG, Cilander, E. Schellenberg Textildruck AG, Mammut Sports Group, Schoeller Textil AG, Serge Ferrari Tersuisse AG, and TISCA Tischhauser & Co. AG. So that it can pass on even more textile expertise to Subitex partners, Empa has invested part of the financial contributions from Subitex in the "Self-care materials" research program of the Competence Center for Materials Science and Technology (CCMX) of the ETH domain. This program investigates the substance emission and absorption properties of fiber structures. The CCMX program is a mix of basic and industrial research and is extremely lucrative, because the Swiss National Fund (SNF) contributes the same amount to the program as that contributed by the industry. For this purpose, Empa's electrospinning and microfluidics systems develop fiber systems from smart polymers. These systems respond to external influences such as temperature, pH value, humidity, or pressure. Today's systems use small, passive capsules that can only release substances by decomposing. What makes self-care materials special is that their innovative fiber systems release substances in a targeted way over a specific period of time when they are "activated." Very small fibers made from smart polymers can be used not only in biomedical textiles and fabrics, but also in packaging films for the food industry. The SUBITEX research initiative is scheduled to last five years and will continue to run until 2020. More information: For further information, see: subitex.empa.ch
News Article | May 16, 2017
Organic light-emitting diodes (OLEDs) are the light sources of the future. Luminescent paintwork on cars, colorful living room walls and kitchen ceilings that light up, billboards of a very different kind – all this will now be conceivable. Last year the EU project TREASORES, coordinated by Empa, created flexible, transparent electrodes, the basis for supple, rollable OLEDs. Acquiring the experience to fabricate and functionalize the multi-layered structures of OLEDs light sources is the next step forward. After all, manufacturing a homogenously lit wallpaper is anything but trivial. Thus, expertise from the industry is urgently called for. Anand Verma brings these expertise and know-how to the table. He started his career as a professional conventional printer at India Today after obtaining a Bachelor of Engineering in printing and media technology from Manipal Insititute of Technology. He extended his knowledge to the developing field of printed electronics by gaining a Master's degree at Chemnitz University of Technology (Germany). With his extensive research work on OLEDs in cooperation with Holst Center in Eindhoven (Netherlands), Novaled (Germany) and Cynora GmbH (Germany), he gained expertise to develop inks and new printing processes for OLED fabrication. At Empa, as a coating / printing expert his area of research involves developing wet coating and printing for the Coating Competence Center (CCC). At CCC, he works on printing perovskite solar cells, actuators, and the like. Besides, he continues to explore the printing of flexible OLEDs on various substrates. "I can estimate optimal layer architectures, which will function in OLEDs depending on the substrates being investigated," says Verma. "So I also know the process parameters that need to optimized besides ink composition." Most of the light sources we are familiar with are point light sources or neon tubes. OLEDs, on the other hand, are surface lights. "If you look at OLED structure," explains the Empa researcher, "they consist of multiple nanometer-thin layers." The positively charged anode usually consists of transparent indium tin oxide (ITO), which can be used to produce electrically conductive windows or films. This is followed by an organic semiconductor layer (poly 3, 4-ethylenedioxythiophene polystyrenesulfonate, PEDOT:PSS), a light emitting layer (Super Yellow, fluorescent color), calcium for work function and a cathode, usually made of aluminum. It takes up to three days to produce a batch of OLEDs. First of all, it is important to clean the ITO substrate carefully as even tiny specks will show up on the finished product later on – especially because the layers are only a few nanometers thin. Electronically and morphologically stable layer architecture differentiates between a good and bad performing OLED: "Generally, the thinner the layers, the higher the risk of inhomogeneity during wet coating. On the other hand: if the layers are thicker, a higher turn-on voltage is needed to achieve the same luminosity," says Verma. After the cleaning phase, the substrate is treated with an oxygen plasma: it is bombarded with ions to increase the surface energy, which facilitates wetting behavior of inks thus obtaining a homogeneous layer. It is important for the substrate's surface energy to be higher than that of the ink being coated. "Depending on the surface energy of the material and surface tension of the ink, it either wets the surface or it de-wets it. However, in some cases treating the substrate is not enough. When producing the ink – for the next layer of material – Verma first has to work out the right solvent in the ideal concentration to achieve the desired surface energy level, required thickness and morphology. Moreover, the solvent should be as environmentally friendly as possible. "If we chose chloroform, for instance," says Verma, "this would have a harmful impact on health during the production phase because rather high quantities of it are required." One of the used inks is Super Yellow. The most important layer is the light-emitting one. It is crucial for the researcher to already make this ink 24 hours beforehand as it takes that long for the solvent to dissolve in the dye. In contrast to the previous layers, calcium and subsequently aluminum is vacuum evaporated. To do so, the printing specialist has to use a glove box including a vacuum chamber to prevent the oxidation of calcium. Why opt for such a sensitive metal? "You could also use a different one. But all those that make suitable candidates are in the same group in the periodic table; they all oxidize." To use the fabricated devices in ambient conditions, Verma has to encapsulate the finished OLED to protect it from oxidation and moisture. This requires another layer made of transparent film or glass and special glue, which hardens under influence of UV light. The tests involving the different substrates and the carriers for these flexible OLEDs will run until Empa's demonstrators light up reliably. Anand Verma is already thinking of the next step: "Printing and coating devices at Empa's new Coating Competence Center would already be capable of producing OLED patterns or surfaces on a larger scale." The lighting from the lab is within reach. Explore further: Why you should get ready to say goodbye to the humble lightbulb
News Article | May 4, 2017
NEW YORK--(BUSINESS WIRE)--Artsy in collaboration with UBS today released the first film in a multi-part 360° documentary series “Inside the Biennale” exploring the 57th Venice Biennale. In the spirit of increased access to the world’s premier art exhibition, these films will build on the success of Artsy and UBS’s first collaboration, an 11-part series on the 2015 Venice Biennale, providing a global audience an insider’s glimpse of the Biennale’s most engaging art, personalities, and performances. Featuring luminary artists and curators, including Cecilia Alemani, Carol Bove, Dawn Kasper, Massimiliano Gioni, Christian Marclay, Francis Upritchard, Erwin Wurm, and more, the films will transport viewers from studios, galleries, and institutions around the world to the iconic city, delving deep into the Biennale buzz as Venice prepares for the exhibition’s opening. Filmed “in the round,” the films will provide viewers a unique, immersive view of the city and exhibition. The first 360° film explores the story of the Venice Biennale through the perspectives of several artists and curators as they create artworks and prepare installations that will be on view at the Biennale’s national pavilions. Following today’s launch, additional films will be released on Artsy throughout the first months of the Biennale. This is the fifth iteration of Artsy and UBS’s partnership, following collaborations on a series of films focused on the 2015 Venice Biennale; Year in Art editorial features from 2015 and 2016; and a four-part film series lifting the curtain on the art market, which debuted last year. “We’re proud to be collaborating again with UBS, a partner that shares our dedication to providing greater access to the world’s most influential artists and exhibitions,” said Sebastian Cwilich, Artsy’s President and COO. “The Venice Biennale is a uniquely important cultural moment and we’re excited to share it with Artsy’s millions of monthly visitors in this cutting-edge new format.” “Our latest collaboration with Artsy—the ‘Inside the Biennale,’ VR documentary series—reflects our shared commitment to making the dynamic world of contemporary art more accessible to a broader public by using state-of-the-art technology,” stated Johan Jervøe, Group Chief Marketing Officer, UBS. “These films help advance a deeper understanding of the art world in much the same way as we help our clients navigate complex challenges and opportunities in the financial world.” Artsy commissioned virtual reality studio Scenic to direct the films, which will be viewable on both desktop and mobile, as well as through an enhanced viewing experience in virtual reality headsets. To accompany the films, Artsy tapped artists Erwin Wurm and Dawn Kasper to design limited-edition cardboard virtual reality viewers, which will be distributed in Venice. To view the films go to https://www.artsy.net/venice-biennale/toward-venice. Artsy is the leading destination for exploring and collecting art from the world’s top galleries, museums, art fairs, and auction houses. Artsy partners directly with the most influential players in the art world, providing collectors and enthusiasts a central resource to learn about and purchase artwork from anywhere in the world. Powered by The Art Genome Project, a personalization system that maps the connections between artists and artworks, visitors to Artsy can browse art from the world’s leading museums, collect artworks from thousands of top galleries, explore international art fairs before they open to the public, bid in auctions from leading auction houses, and read about the art world in the world’s most-read art publication. Our mission is to make all the world’s art accessible to anyone with an internet connection. UBS’s long and substantial record of patronage in contemporary art enables clients and audiences to participate in the international conversation about art and the global art world through the firm’s global art platform. In addition to the UBS Art Collection, considered one of the world’s largest and most important corporate collections of contemporary art, UBS has an extensive roster of contemporary art programs that include the firm’s long-term support for the premier international Art Basel shows in Basel, Miami Beach and Hong Kong, for which UBS serves as global Lead Partner; the Guggenheim UBS MAP Global Art Initiative with the Solomon R. Guggenheim Museum; and a global exhibition tour of “WOMEN: New Portraits,” an exhibition of newly commissioned photographs by renowned photographer Annie Leibovitz. These activities are complemented by a number of regional partnerships with fine art institutions including the Fondation Beyeler in Switzerland, Galleria d’Arte Moderna in Milan, the Nouveau Musée National de Monaco, the Louisiana Museum of Modern Art in Denmark, the Deichtorhallen in Hamburg and the Art Gallery of New South Wales in Sydney, Australia. UBS also provides its clients with insight into the contemporary art world through the free art news app UBS Planet Art, collaborations with the Swiss Institute, and the online resource Artsy, as well as through the UBS Art Competence Center and UBS Arts Forum. For more information about UBS’s commitment to contemporary art, visit ubs.com/art. Scenic is a virtual reality content studio based in Brooklyn exploring new directions in non-fiction VR. Founded by filmmaker Gary Hustwit, the studio covers a wide range of topics in art, culture, design and music with cinematic VR and 360° video to push the boundaries of immersive storytelling. Scenic’s creative team includes acclaimed documentary filmmakers and visual artists, and the studio’s first batch of VR documentaries was recently released in collaboration with The Wall Street Journal and Google.
News Article | May 10, 2017
After nine months of construction time, staff moved in to the new Novi premises in Michigan a few weeks ago. The new Autoneum facility brings together research and development activities in the North American market with the management of Business Group North America. "Our new Technical Center here in Novi sets the stage to better meet regional customer and market requirements. This facility enables us to further extend our innovation leadership in a profitable way," underlined John Lenga. The Technical Center marks a significant expansion of the Company's development capabilities in North America. In addition to the development and adaptation of noise- and heat-reducing vehicle components for the North American market, vehicle predevelopment studies with customers will also be conducted. The Technical Center features state-of-the art laboratories and an expanded development space that gives Autoneum new capabilities for simulation and testing of components, production lines and processes. Integrating administration functions with the Technology Center will both intensify cooperation between development, purchasing and sales and ensure optimal use of synergy with the Competence Center for New Mobility established in early 2017 in Sunnyvale, California. The new facility encompasses more than 7,800 square meters (84,000 square feet), with an environment designed to promote innovation and collaboration among the 175 employees. Modern workplaces and meeting rooms equipped with the latest media technology facilitate efficient collaboration between the North America Headquarters, the Group Headquarters in Switzerland and the sites around the world. In North America, Autoneum operates eight production facilities in the USA (Aiken/SC, Bloomsburg/PA, Jeffersonville/IN, Oregon/OH, UGN: Jackson/TN, Monroe/OH, Somerset/KY, Valparaiso/IN), two in Canada (London/ON, Tillsonburg/ON) and three in Mexico (Hermosillo, San Luis Potosí, UGN: Silao) as well as two development centers (Novi/MI, Sunnyvale/CA). 4350 employees, 3650 of them in the USA, make sure that customers in North America benefit from lightweight and multifunctional components for acoustic and thermal management in vehicles. Autoneum customers in North America include all US OEMs as well as German and Japanese OEMs. Autoneum, with its headquarters in Winterthur, Switzerland, is the globally leading producer of vehicle acoustics and thermal management systems. The company develops and manufactures components, modules and complete systems for interior and engine bay as well as heatshields and underbody shields. Customers include leading automobile producers in the key markets of Europe, North America, South America and Asia. Autoneum is represented at around 50 locations in over 20 countries and employs more than 11,000 people worldwide, of whom about 5% are in Switzerland. The company is listed on the SIX Swiss Exchange (ticker symbol AUTN). For further information please contact: Investors and Financial Analysts Dr Martin Zwyssig CFO T +41-52-244-82-82 F +41-52-244-83-37 firstname.lastname@example.org Media Dr Anahid Rickmann Head Corporate Communications & Responsibility T +41-52-244-83-88 F +41-52-244-83-36 email@example.com
News Article | May 25, 2017
First, diesel vehicles tainted their reputation with soot particles, then high nitric oxide emissions. So are owners of new gasoline cars environmentally friendly? Not always, says a new study led by Empa scientists: some direct-injection gasoline engines emit just as many soot particles as unfiltered diesel cars did in the past. Particle filters can remedy this. Worldwide, three new cars roll off the line every second -- that's 73 cars and 18 million utility vehicles per year. Most run on gasoline. In industrialized nations, the trend is moving towards so-called downsizing engines: smaller but with direct gasoline injection and turbocharging. This technology is kind to the environment and saves fuel, the manufacturers say. Experts estimate that by 2020, 50 million of these direct-injection gasoline engines will be running on the roads all over Europe -- high time the cocktail of exhaust emissions from these engines were examined closely. In the spring 2014, the GasOMeP project (Gasoline Vehicle Emission Control for Organic, Metallic and Particulate Non-Legislative Pollutants) got underway. The Paul Scherrer Institute (PSI), Bern University of Applied Sciences, the University of Applied Sciences and Arts Northwestern Switzerland, several industrial partners and Empa were all involved. The project was funded by the ETH Domain's Competence Center for Energy and Mobility (CCEM) and coordinated by Empa chemist Norbert Heeb, who has made a name for himself in the last 25 years by analyzing diesel emissions and studying filter systems. The team selected seven direct-injection gasoline cars, including a Mitsubishi Carisma (2001 model, exhaust emission standard Euro 3). The other vehicles were all built between 2010 (VW Golf, Euro 4) and 2016 (Citroën C4, Euro 6b). By way of comparison, a current Peugeot 4008 (2013, Euro 5b) with a diesel engine and a particle filter was also included. All the vehicles were tested based on the WLTP cycle (Worldwide Light-Duty Vehicles Test Procedure), which will be mandatory for newly licensed models as of September 2017 (see p. 10). The results were sobering: every single one of the tested gasoline cars emitted ten to 100 times more fine soot particles than the diesel Peugeot. Under the microscope, the particles from the gasoline engines were similar in size to the soot particles that had given diesel a bad name: primary particles measuring ten to 20 nanometers in size, which congregate into particle agglomerates measuring 80 to 100 nanometers before leaving the exhaust. "Once inhaled, these particles remain in the body forever," explains Norbert Heeb. The evidence shows that they can penetrate the membrane of human alveoli in the lungs and thus get into the bloodstream. However, the particles are not the only problem, as Heeb is well aware: "Liquid or solid chemical toxins from the combustion process, including polycyclic aromatic compounds, accumulate on the surface of the particles, which can then smuggle these substances into the bloodstream -- like a Trojan horse." Maria Munoz, a colleague of Heeb's from Empa's Advanced Analytical Technologies lab, took a closer look at the exhaust emissions from the vehicles tested in the GasOMeP project -- and discovered the combustion product benzo(a)pyrene, a known carcinogenic substance also found in cigarette smoke. The World Health Organization (WHO) considers even the tiniest dose of benzo(a)pyrene harmful. The EU settled on an air limit of one nanogram per cubic meter. Levels in exhaust emissions were found to be as much as 1,700 times above this limit. Or to put it another way, one cubic meter of exhaust gas transforms up to 1,700 cubic meters of clean air into a mixture deemed carcinogenic according to the EU standard. Once again, the diesel vehicle with particle filter fared much better: in the test, the Peugeot emitted only 45 nanograms of carcinogenic substances -- 6 times less than the best one of the analyzed gasoline cars. The results of the GasOMeP project were presented during a conference held at the Empa Academy in late March. The conclusion of the researchers involved: particle filters are established in diesel vehicles and have offered advanced technology for years; based on the current data, they should now also be mandatory for gasoline vehicles. "At the moment, they don't incorporate the best available technology," criticizes Heeb, urging haste: "New exhaust emission technologies launched on the market usually take around 13 years to become fully effective. Only then will nine out of ten cars from the vehicle stock be replaced. So the sooner particle filters are made mandatory for gasoline vehicles, the better it will be for everyone's health."
News Article | May 24, 2017
« Arizona now permits sale of isobutanol-blended gasoline for on-road vehicles | Main | Santa Clara Valley orders 47 New Flyer Xcelsior 60' diesel-hybrid buses » Based on a three-year study of toxic and environmentally relevant pollutants from gasoline direct injection (GDI) engines, Swiss researchers have concluded that some GDI engines emit just as many soot particles as unfiltered diesel cars did in the past. Further, the GDI particles carry numerous carcinogenic substances. Based on this current data, they recommend that particulate filters be mandatory for GDI engines. In the spring 2014, the GasOMeP project (Gasoline Vehicle Emission Control for Organic, Metallic and Particulate Non-Legislative Pollutants) got underway. The Paul Scherrer Institute (PSI), Bern University of Applied Sciences, the University of Applied Sciences and Arts Northwestern Switzerland, several industrial partners and Empa were all involved. The project was funded by the ETH Domain’s Competence Center for Energy and Mobility (CCEM) and coordinated by Empa chemist Norbert Heeb, who has made a name for himself in the last 25 years by analyzing diesel emissions and studying filter systems. The results of the GasOMeP project were presented during a conference held at the Empa Academy in late March. For the study, the team selected seven direct-injection gasoline cars, including a Mitsubishi Carisma (2001 model, exhaust emission standard Euro 3). The other vehicles were all built between 2010 (VW Golf, Euro 4) and 2016 (Citroën C4, Euro 6b). By way of comparison, a current Peugeot 4008 (2013, Euro 5b) with a diesel engine and a particle filter was also included. All the vehicles were tested based on the WLTP cycle (Worldwide Light-Duty Vehicles Test Pro-cedure), which will be mandatory for newly licensed models as of September 2017. The results were sobering: every tested gasoline car emitted ten to 100 times more fine soot particles than the diesel Peugeot. Under the microscope, the particles from the gasoline engines were similar in size to the soot particles that had given diesel a bad name: primary particles measuring ten to 20 nanometers in size, which congregate into particle agglomerates measuring 80 to 100 nanometers before leaving the exhaust. The evidence shows that they can penetrate the membrane of human alveoli in the lungs and thus get into the bloodstream. However, the particles are not the only problem. Heeb notes that liquid or solid chemical toxins from the combustion process, including polycyclic aromatic compounds, accumulate on the surface of the particles, which can then smuggle these substances into the bloodstream like a Trojan horse. Maria Munoz, a colleague of Heeb’s from Empa’s Advanced Analytical Technologies lab, took a closer look at the exhaust emissions from the vehicles tested in the GasOMeP project and discovered the combustion product benzo(a)pyrene, a known carcinogenic substance also found in cigarette smoke. The World Health Organization (WHO) considers even the tiniest dose of benzo(a)pyrene harmful. The EU settled on an air limit of one nanogram per cubic meter. Levels in exhaust emissions were found to be as much as 1,700 times above this limit. Or to put it another way, one cubic meter of exhaust gas transforms up to 1,700 cubic meters of clean air into a mixture deemed carcinogenic according to the EU standard. Once again, the diesel vehicle with particle filter fared much better: in the test, the Peugeot emitted only 45 nanograms of carcinogenic substances—6 times less than the best one of the analyzed gasoline cars.
News Article | February 27, 2017
Reduction of 63% in overall attack rate in HAE patients with severe disease (p=0.006) RESEARCH TRIANGLE PARK, N.C., Feb. 27, 2017 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced results from an interim analysis of its Phase 2 APeX-1 trial in hereditary angioedema (HAE). APeX-1 is a dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered once daily (QD) BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE patients. “The results of this interim analysis are extraordinarily encouraging,” said Dr. Emel Aygören-Pürsün, MD, principal investigator for the APeX-1 trial and Head of Interdisciplinary Competence Center for Hereditary Angioedema, and Specialist in Internal Medicine and Hemostaseology Department of Child and Adolescent Medicine, Goethe University Hospital Frankfurt. “Confirmation of the results would lead to a huge step forward in the treatment of hereditary angioedema, towards an effective, safe and easy to administer prophylaxis for the debilitating attacks connected with this condition.” “We are extremely excited to have such a strong treatment effect in reducing HAE attacks with our once daily oral therapy,” said Jon Stonehouse, Chief Executive Officer & President of BioCryst. "What is even more encouraging is the dramatic benefit seen in the reduction of peripheral attacks and mixed peripheral and abdominal attacks. A once daily oral therapy with an 88% reduction in these attacks has the potential to make a huge difference in HAE patients’ lives.” Twenty-eight subjects, randomized equally to receive BCX7353 350 mg QD or placebo for 28 days, were included in the interim analysis. The baseline attack rate was approximately 1/week, and average C1 inhibitor levels were less than 20% of the normal mean, indicating a severely affected patient population. Baseline characteristics were generally well balanced between the two groups with the exception of prior androgen use, which was more common in the BCX7353 group (11 of 14 compared with 6 of 14 on placebo). Compliance with study drug dosing was excellent (> 98%). The pre-specified per-protocol (PP) interim analysis included data on 24 subjects with confirmed Type 1 or Type 2 HAE completing 28 days of treatment (11 treated with BCX7353 and 13 with placebo). The mean rate of independently-adjudicated angioedema attacks for the pre-defined effective dosing period (weeks 2 through 4) in BCX7353-treated subjects was 0.34/week compared to 0.92/week for placebo, a reduction of 0.57/week (63%), p = 0.006. In the intent-to-treat (ITT) population of 28 subjects, the rates of attacks for the effective dosing period for BCX7353 and placebo groups were 0.44/week and 0.91/week, a reduction of 0.47/week (52%), p = 0.035. A pre-planned analysis of peripheral and abdominal attacks showed reductions of 88% and 24%, respectively, for BCX7353 compared with placebo (PP analysis, weeks 2 through 4). To understand this difference, patient diaries were reviewed and abdominal attacks (n = 9, BCX7353 and n = 14, placebo) were subdivided into two groups: attacks with abdominal symptoms only and attacks with a combination of abdominal and peripheral symptoms (mixed attacks). This post-hoc analysis showed that there were 2, 2 and 7 peripheral, mixed and abdominal-only attacks on BCX7353 compared with 22, 12 and 2 attacks, respectively, for placebo. Based on this distribution, it is likely that subjects recorded transient abdominal adverse events as HAE attack symptoms in their diary. Steady state BCX7353 plasma levels in HAE subjects were similar to those in healthy subjects administered the same dose in a previously completed Phase 1 trial. Steady state trough drug levels (24 hours after dosing) were 11 – 32 times the 50% effective concentration (EC ) for plasma kallikrein inhibition. Daily oral dosing with BCX7353 strongly inhibited plasma kallikrein throughout the 24 hour dosing interval; the degree of inhibition was similar to that seen with this dose in the healthy subject Phase 1 trial. Oral BCX7353 350 mg once-daily for 28 days was generally safe and well tolerated in subjects with HAE. There were no serious adverse events (AEs) and no related severe AEs. Two subjects in the BCX7353 treatment group discontinued study drug before day 28, one due to an unrelated pre-existing condition, and one due to an adverse event of gastroenteritis associated with elevated liver enzymes. Treatment-emergent adverse events occurring in at least 2 subjects overall, enumerated by treatment group (BCX7353 [n=14] and placebo [n=14]), were: common cold (3, 4); diarrhea (4, 2); flatulence (2, 0); and fatigue (2, 0). No clinically significant changes in hematology parameters, renal function tests, electrolytes, or urinalysis were observed. One subject treated with BCX7353, with pre-existing colitis, hepatic steatosis (fatty liver) and more than 20 years of prior androgen use, had an elevation of alanine aminotransferase (ALT) > 3 times the upper limit of normal at the end of treatment, which resolved. The efficacy, safety and tolerability profile of BCX7353 observed in this interim analysis strongly supports its continued investigation as a prophylactic treatment for HAE. The steady state drug levels observed far exceeded the proposed therapeutic target range of 4 – 8 times the EC , supporting evaluation of lower doses. Therefore, the APeX-1 trial has been amended to add a 62.5 mg QD dose level and to increase the number of subjects at the 125 mg QD and 250 mg QD dose levels, in order to more fully characterize dose response. BioCryst's leadership team will host a conference call and webcast with Dr. Emel Aygören-Pürsün, MD and Prof. Bruce Zuraw, MD, Division Chief, Professor of Medicine UC San Diego School of Medicine and Director of the U.S. HAEA Angioedema Center today, February 27, 2017 at 9:00 a.m. Eastern Time, to discuss its APeX-1 interim analysis and to respond to questions on the APeX-1 interim results and the Company’s full year 2016 financial results. To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed by logging onto www.BioCryst.com. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary. BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst currently has several ongoing development programs: BCX7353 and second generation oral inhibitors of plasma kallikrein for hereditary angioedema, and galidesivir, a broad spectrum viral RNA polymerase inhibitor that is a potential treatment for filoviruses. Peramivir, a viral neuraminidase inhibitor, is approved for the treatment of influenza, in the U.S., Canada, Japan, Taiwan and Korea. Post-marketing commitment development activities are ongoing, as well as other activities to support additional peramivir regulatory approvals. For more information, please visit the Company's website at www.BioCryst.com. This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: developing any HAE drug candidate may take longer or may be more expensive than planned; ongoing and future preclinical and clinical development of HAE second generation drug candidates (including APeX-1) may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the Company may not advance human clinical trials with product candidates as expected; that the FDA may require additional studies beyond the studies planned for product candidates, or may not provide regulatory clearances which may result in delay of planned clinical trials, or may impose a clinical hold with respect to such product candidate, or withhold market approval for product candidates; that BioCryst may not receive additional government funding to further support the development of galidesivir; that galidesivir development may not be successful; that BARDA and/or NIAID may further condition, reduce or eliminate future funding; that revenue from peramivir is unpredictable and commercialization of peramivir may never result in significant revenue for the Company; that the Company may not be able to continue development of ongoing and future development programs; that such development programs may never result in future products; that actual financial results may not be consistent with expectations, including that 2017 operating expenses and cash usage may not be within management’s expected ranges. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.
News Article | December 7, 2016
TAINAN, Taiwan--(BUSINESS WIRE)--National Cheng Kung University (NCKU) Office of International Affairs (OIA) sets up Global Competence Center (GCC) to provide more opportunities for local students and international students to get to know one another and broaden their global views. GCC offers international students the opportunities to take part in the activities at NCKU. The process of participating in those activities enables them to make new friends with the local students, and thus making the international students more familiar to the Taiwanese culture and custom. GCC also integrates the existing services of OIA, including Global Forum, Student-centered International Forum, Service Learning, Language Exchange, In-campus Volunteer, Host Family Network, Global Internship and many others, hoping to make the resources more effective to the local students and to lead them to recognize and respect different cultures from countries to countries. Global Forum guides the participants to discuss international issues in English. The forums can be either lectures or experience sharing. There are approximately 4 forums per semester, and they aim to motivate the students at NCKU to engage in global issues. Student-centered Forum gives the local students the information of participating in international contests and overseas training programs. OIA hopes students can cultivate leadership skills and develop self-recognition by experiencing various cultures. Global Internship Program is highly promoted. NCKU has been collaborating with numerous prestigious universities abroad, aiming to offer the local students short-term exchanges and internships. NCKU has also been promoting the international student exchange program and inviting a number of foreign scholars to NCKU recently. As a result, the number of foreigners at NCKU has been soaring. OIA hopes that the foreigners and the natives can have better connections through GCC’s efforts.