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News Article | May 11, 2017
Site: news.yahoo.com

On April 24, New Orleans city employees began the process of removing four Confederate monuments. But there are pitfalls in eliminating memorials to the Confederacy – statues and monuments, along with the buildings, parks, schools and military bases named after Confederate soldiers. Primarily, we risk forgetting the connections of past racial crimes to current racial inequality. Statues of Confederate soldiers are common in the South in a number of courthouse squares, while streets and parks bear the names of people or events associated with the Confederacy. In Southampton, Virginia, Black Head Signpost Road is named for the head of a slave executed during the Nat Turner Rebellion. (His head was put on a post along the road as a warning.) Jefferson Davis Memorial Highway, which runs from Florida to California, was named in the 1920s. The Virginia legislature even continues to pay US$5 per year to cemeteries in the state for every Confederate soldier buried in them. (The money is supposed to help preserve the cemeteries.) In prior years, some cities and institutions have responded to the concerns of those who view these monuments as distasteful symbols of discrimination and oppression. In little towns throughout the South, from Reidsville, North Carolina to Southampton County, Virginia (scene of the Nat Turner Rebellion), Confederate statues have been moved from courthouse squares and town centers to less prominent places, like cemeteries. Meanwhile, buildings named after Confederate officers (such as Saunders Hall at the University of North Carolina), Klansmen (Simkins Hall at the University of Texas-Austin) and politicians supporting Jim Crow (Governor Charles Aycock at Duke and East Carolina) have been renamed. In recent years, the call to remove or rename is getting even louder. In 2015, Senator Mitch McConnell said Kentucky should consider ridding the Kentucky State House of its Jefferson Davis statue; in Memphis, one City Council member drew up an ordinance to remove the statue of Confederate cavalry officer and Klansman Nathan Bedford Forrest from a public park; and Tennessee’s governor has suggested that a bust of Forrest be removed from State Capitol grounds. Some monuments may be so offensive to the local community that they’ll need to be removed. And certainly, they can serve as rallying points for contemporary white supremacists. Others are particularly poignant reminders of the days of slavery and Jim Crow. Nathan Bedford Forrest Park, in an African American section of Memphis, was renamed because the City Council thought it was an affront to the local population. In such cases, the redistribution of cultural capital may serve to stop a continuing harm. This is a decision that should largely be made at the local level. However, the legislatures of four states – South Carolina , Georgia, Mississippi and Tennessee – have passed Heritage Protection Acts that prohibit the removal of Confederate monuments from public property (or renaming of public buildings). This movement started in South Carolina in 2000, and the statues were pushed by supporters of Confederate heritage. Clearly, there’s a lot of work to be done if we’re going to completely wipe out all traces of names and structures that honor the Confederacy. However, while I’m no supporter of the Confederacy, there are several reasons not to remove monuments or rename buildings. As an aside: Confederate flags are entirely different. New flags have to be put up constantly, because they can wear out quickly. Thus, flying a Confederate flag reflects a continuing commitment to maintaining a symbol of white supremacy. Confederate monuments, on the other hand, were almost all erected decades ago. For this reason, they’re part of our landscape. Yes, they’re reminders of the days of slavery and secession. But they teach important lessons: they point to a Southern political system that, from the 1870s to the 1930s (the period of most frequent commemoration), continued to support the ideals of the Confederacy. They’re graphic reminders of Jim Crow, and the ways white supremacy was codified in statutes, social practices and stone. And they reveal the psychology (however misguided) of an era and people: the fact that white Southerners and their elected leaders believed in the righteousness of their society. Ultimately, removal of the monuments will, quite literally, erase an unsavory – but important – part of our nation’s history. In present-day poverty, the echoes of a racist past There’s a second reason to go slow on renaming. It’s important (for individuals, as well as communities) to understand how our past is connected to the present. The legacy of violence and limited educational and vocational opportunities during the eras of slavery and Jim Crow are undeniably connected to the fact that one-third of African American children today live in poverty. Those who argue for expanded social welfare spending to alleviate the ravages of poverty make the plea that poverty is related not to personal culpability, but to legacies of racism that have lasted for generations. Confederate statues are tangible symbols of this legacy of oppression. They’re another reminder of the need for nuance in the telling of our nation’s history; in understanding how we get to where we are today, we need to acknowledge the good along with the bad – which means not tearing it down. Editor’s note: This is an updated version of an article first published on July 8, 2015. This article was originally published on The Conversation. Read the original article.


In addition, systolic blood pressure (SBP) in the subset of type 1 diabetic patients in the study with baseline hypertension (SBP ≥130 mmHg) was reduced by 9.9 mmHg and 11.0 mmHg at week 12 when treated with 200 mg and 400 mg of sotagliflozin, respectively, compared to a reduction of 4.4 mmHg on placebo (p=0.017 and p=0.003 for the 200 mg and 400 mg doses, respectively). Notably, the outcome on every secondary endpoint favored sotagliflozin over placebo, with results for the 400 mg dose having achieved statistical significance for all six secondary endpoints (results for the first two secondary endpoints were also statistically significant for the 200 mg dose): Sotagliflozin was generally well tolerated during the 28-week extension period, with rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to AEs that were consistent with rates seen in the initial 24-week treatment period. The rate of severe hypoglycemia was the same or lower for the sotagliflozin arms than placebo during the 28-week extension period (10 patients (4.3%) for placebo, compared to 10 (4.2%) and 6 (2.5%) for sotagliflozin 200 mg and 400 mg, respectively), and was slightly lower overall than the rate seen in the initial 24-week treatment period. The rate of diabetic ketoacidosis (DKA) during the 28-week extension period was slightly higher than the rate seen in the initial 24-week treatment period for placebo (one patient, 0.4%) and the 200 mg dose arm (6, 2.5%) and lower for the 400 mg dose arm (3, 1.3%). "Sotagliflozin's ability to improve both A1C and other measures of health such as body weight and blood pressure holds promise for addressing important areas of need in type 1 diabetes, and the additional inTandem1 results announced today highlight the differentiated profile of sotagliflozin in the type 1 diabetes landscape," said Lonnel Coats, Lexicon's president and chief executive officer. "In the coming weeks, we look forward to the outcome of inTandem3, with its 'net benefit' primary efficacy endpoint that measures the proportion of patients achieving an A1C of less than 7% without a severe hypoglycemia or DKA event. We saw favorable results on the same endpoint in inTandem1 and inTandem2 and remain confident about replicating these data in inTandem3." "Type 1 diabetes is a tough disease for patients and their providers to take care of. The potential of sotagliflozin to lower blood glucose and favorably affect body weight and blood pressure is tremendous," said John Buse, M.D., Ph.D., lead investigator of inTandem1 and Professor of Medicine, Chief of the Division of Endocrinology and Metabolism, Director of the Diabetes Care Center, and Executive Associate Dean for Clinical Research at the University of North Carolina School of Medicine. "If approved, sotagliflozin could be an important oral therapy for individuals with type 1 diabetes while on insulin." The Phase 3 study known as inTandem1 was a double-blind, placebo-controlled, multi-center study of 793 patients in the U.S. and Canada with type 1 diabetes on insulin pump or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo. Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone. After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured. The mean baseline A1C level at the time of randomization after the six-week optimization period was 7.6% for all three dose arms. The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment. The trial had a double-blind long-term extension of 28 weeks, with a total treatment duration of 52 weeks. There were 268 patients in the placebo arm, 263 patients in the 200mg dose arm, and 262 patients in the 400 mg dose arm. The overall mean placebo adjusted A1C reduction was 0.35% in the 200 mg dose arm (p<0.001) and 0.41% in the 400mg dose arm (p<0.001) over the initial 24-week treatment period. The A1C benefit achieved with sotagliflozin was sustained over the full 52-week duration of the study for both the 200 mg and 400 mg doses (p<0.001 at week 52). Sotagliflozin was generally well tolerated during the study. Across all three dose arms (placebo, 200mg, 400mg), over the full 52 weeks of treatment, the incidences of AEs were 80.6%, 81.7% and 79.8%, respectively; the incidences of SAEs were 7.5%, 10.3% and 11.1%, respectively; and discontinuations due to AEs were 4.1%, 4.9% and 6.5%, respectively. There was one death in the study in the placebo arm and no deaths in either sotagliflozin arm. Two primary safety concerns for patients with type 1 diabetes are severe hypoglycemia and DKA. The number of patients with severe hypoglycemia events during the full 52 weeks of treatment was 26 (9.7%), 17 (6.5%), and 17 (6.5%) in the placebo, 200 mg and 400 mg dose arms, respectively. The number of patients with DKA events during the full 52 weeks of treatment was 1 (0.4%), 9 (3.4%), and 11 (4.2%) in the placebo, 200 mg and 400 mg dose arms, respectively. Lexicon is conducting another, similar pivotal Phase 3 clinical trial predominantly in Europe (inTandem2), from which top-line, primary efficacy endpoint and safety data at 24 weeks has previously been reported and additional data from secondary endpoints as well as pooled continuous glucose monitoring (CGM) results from inTandem1 and inTandem2 are expected in the third quarter of 2017. Lexicon is conducting a third, global Phase 3 clinical trial, inTandem3, studying approximately 1,400 type 1 diabetes patients treated with sotagliflozin 400mg once daily or placebo on a background of any insulin therapy, but without insulin optimization prior to randomization. Top-line data from inTandem3 is expected in the coming weeks. Discovered using Lexicon's unique approach to gene science, sotagliflozin is a first-in-class, oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin has been shown in a Phase 2 study to improve glycemic control in people with type 1 diabetes while reducing their need for mealtime insulin. Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and retains an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the U.S. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. (excluding Japan). Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its recently-launched product for carcinoid syndrome diarrhea, XERMELO™ (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com. This press release contains "forward-looking statements," including statements relating to Lexicon's and its licensees' clinical development of and regulatory filings for sotagliflozin and the results and projected timing of clinical trials and the potential therapeutic and commercial potential of sotagliflozin. In addition, this press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the risk that clinical studies of sotagliflozin may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that the FDA and other regulatory authorities may not grant regulatory approval of sotagliflozin in accordance with Lexicon's currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of sotagliflozin. As a result, sotagliflozin may never be successfully commercialized. Other risks include Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other potential drug candidates, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/lexicon-pharmaceuticals-reports-additional-positive-data-from-pivotal-intandem1-phase-3-study-for-sotagliflozin-in-patients-with-type-1-diabetes-300455820.html


Earlier in the school year, Oculus sent Ola Björling, Global Director of Virtual Reality Marketing for MediaMonks, to campus as a guest artist. "MediaMonks is the biggest creative digital production company on the planet," said School of Filmmaking Dean Susan Ruskin. "It was a phenomenal experience for our students because Ola has not only technical expertise surrounding virtual reality, but he also has a philosophical understanding of virtual reality's potential impact on digital storytelling." Also this year, film students worked alongside professional filmmakers to produce a VR pilot called DecipHER. Guest artists for the project included Jacquie Barnbrook (producer of the Martian VR Experience and visual effects producer of The Jungle Book and The Hunger Games; Eric Hann, cinematographer, visual effects supervisor and VR photographer; and Alexa Hann, a writer, director and producer who started her career at Disney and is now focusing her talents in developing VR. "When I first started looking into virtual reality it seemed apparent that this was the way the world was going," Ruskin said. "It felt to me the best way for our students to really learn was to get up on their feet, do a production and do it with people who have the experience." Fifty students across every discipline in the film school were involved with the DecipHER project, and each lunch hour was devoted to a question-and-answer session with the guest artists.  "We all learned a tremendous amount from each other," Ruskin said. "Together, we are all learning how to approach storytelling and problem solving in this new environment, using highly sophisticated equipment." Some of that equipment was provided by Radiant Images, a leading rental house for VR equipment. "We are extremely fortunate to partner with Radiant Images, which provides equipment and training that we would not be able to afford," Ruskin said. The equipment was used in the DecipHER project, and also in the year-long course that signaled UNCSA's prominence in the VR medium. Ruskin said the course is a popular elective for students in all film disciplines, with 21 students enrolled and six faculty auditing. "Virtual reality has its own lexicon, its own language. Gamers communicate differently than narrative filmmakers. We are all learning together to communicate more effectively in this new art form," she said. "Both students and faculty are keenly interested in exploring the new frontier of virtual reality programming." New courses will be added to the VR curriculum in Fall 2017 to emphasize different aspects of the medium, and plans are underway to partner with a nearby university to explore the engineering aspect of virtual reality. Beyond that, Ruskin hopes to leverage additional resources like the 14,000-square-foot sound stage in nearby High Point that was donated to UNCSA several years ago. "It is a terrific resource, not only for film production, but also for incubation of new technologies. Technology developers can bring their equipment here to test it, and our students will get to try it out," she said. "That will be very attractive in a field where the technology will continue to change every few months." That experience will give UNCSA students a leg up as they enter the profession, Ruskin added. "We are not just teaching our students how to use current technology, because that will change tomorrow," she said. "We are teaching them how to be technologically nimble. They will master the next generation of virtual reality tools and will be the industry leaders in the years to come." The equipment and training provided by Oculus is a good example. UNCSA received Oculus Rift headsets and touch controllers, Samsung Gear VR headsets and phones, Samsung Gear 360 cameras and Rift-ready top-of-the-line computers from Advanced Micro Devices, equipment that is used in digital gaming and narrative filmmaking. "This is cutting-edge equipment, the most advanced technology available," Ruskin said. "Oculus is the worldwide leader in virtual reality technologies and they are providing a remarkable opportunity for our students to experience storytelling with the technological tools that the industry is using," she said. "We are extremely grateful to Oculus and to industry experts — who are developing the technology and using it every day – for engaging with our students and faculty." Ruskin said more industry collaborations are sure to follow. "We have found partners in the business who are eager to see students learn how to tell stories in this space," she said. The lessons, she added, are exciting for students, teachers and industry pros. "It's always great fun when you are going into a brand new world and nobody's got the answers so it is up to you to figure it out," she said. "That to me is a really good time." UNCSA is America's first state-supported arts school, a unique stand-alone public university of arts conservatories. With a high school component, UNCSA is a degree-granting institution that trains young people of talent in dance, design and production, drama, filmmaking, and music. Established by the N.C. General Assembly in 1963, the School of the Arts opened in Winston-Salem ("The City of Arts and Innovation") in 1965 and became part of the University of North Carolina system when it was formed in 1972. For more information, visit www.uncsa.edu. High resolution images available. Read the story on our webpage. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/innovative-virtual-reality-curriculum-at-uncsa-school-of-filmmaking-sparks-collaboration-with-industry-leaders-300456119.html SOURCE University of North Carolina School of the Arts


News Article | May 12, 2017
Site: news.yahoo.com

Arthur Peekel, center, a former admissions officer at Phillips Exeter Academy, follows his lawyer Philip Utter, left, past reporters after appearing at a hearing at Rockingham County Superior Court in Brentwood, N.H., Friday, May 12, 2017. Peekel plead guilty to assaulting a 14-year-old boy visiting the school in 1973. A judge approved a plea agreement for the 75-year-old, whose 12-month sentence was suspended and is required to register as a sex offender. (AP Photo/Charles Krupa) BRENTWOOD, N.H. (AP) — More than 40 years after he sexually assaulted a prospective student at the prestigious Phillips Exeter prep school, a former admissions officer has pleaded guilty to the charge but will serve no jail time. Rockingham Superior Court Judge N. William Delker on Friday approved a plea agreement for 75-year-old Arthur Peekel, a former Illinois high school Teacher of the Year, whose 12-month sentence was suspended. "While I believe that there is some satisfaction to sending someone like you who committed a crime like this to jail, no amount of jail time is going to right the wrong you committed in this case," the judge told the court, adding that he hoped the guilty plea and sentence would change the culture and show that this "kind of conduct, no matter how long ago it occurred, will come back to roost." Peekel also has to pay a fine of $1,200 and register as a sex offender for the next decade. He showed little emotion as he acknowledged assaulting Lawrence Jenkens when Jenkens visited the school as a 14-year-old in 1973. He never directly addressed Jenkens, who was in court with his family and several alumni, and he left without making any comments. The Associated Press generally doesn't name people who say they're victims of sexual abuse, but Jenkens said he wanted to discuss his case publicly. Peekel was named Teacher of the Year in 1992 while at the Illinois high school. Officials there said they were unaware of the Exeter allegations when they hired him and no allegations were made against him there. Jenkens, who later graduated from Exeter, said he pretended to be asleep as Peekel abused him. He told school authorities repeatedly about the abuse, including meeting with the principal at the time to describe it. But it was only last year Exeter referred his case to the police. When Jenkens was interviewed by police about the abuse, he confronted Peekel over the phone. The conversation was recorded by police in Greensboro, North Carolina, where Jenkens is head of the art department at the University of North Carolina-Greensboro. Jenkens said Peekel apologized on the call but never acknowledged wrongdoing and suggested Jenkens was dreaming. "I think the first thing that Arthur Peekel did was end my childhood," Jenkens said, reading from a statement in court. "I was scared to death that night ... In my experience, children who were abused were murdered ... I assumed that night I was going to die." Jenkens went on to detail how the abuse had haunted him for the past four decades, describing how it made it difficult to form intimate relationships and how he left Exeter "not with a sense of my potential as a young man but instead with sense of grave doubt about my abilities and very little sense of self-worth." But with the guilty plea and sentencing, Jenkens said, he finally has closure and "understands maybe more clearly than ever before that I am a victim, that it wasn't my fault and that I didn't do anything to deserve what happened to me." Concerns about sex abuse at Exeter were first raised following revelations in March 2016 about former teacher Rick Schubart, who was forced to resign in 2011 after admitting sexual misconduct dating to the 1970s. Then, in April, another teacher was fired amid allegations he had sexual encounters with a student decades ago. Then, the Peekel case came to light. Those cases prompted the school to launch its own investigation, leading to a report in which it identified five more former staff members accused of abuse. A law firm commissioned by Phillips Exeter identified four teachers and a psychologist accused of sexually inappropriate behavior involving eight students from 1966 to the 1980s. Three of the accused have died. The other two were barred from campus.


SAN FRANCISCO--(BUSINESS WIRE)--Jaguar Animal Health, Inc. (NASDAQ: JAGX) (Jaguar), an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses, and Napo Pharmaceuticals, Inc. (Napo), a human health company developing and commercializing novel gastrointestinal prescription products from plants used traditionally in rainforest areas, today announced the appointment of Dr. Pravin Chaturvedi, a highly experienced drug development veteran who has spent more than 25 years in the pharmaceutical/biotech industry, as Chair of the combined company’s Scientific Advisory Board, following the expected close of the proposed merger of Jaguar and Napo. Dr. Chaturvedi has served as Chair of Napo’s Scientific Advisory Board since March 27, 2017. Dr. Chaturvedi is responsible for providing direction on strategy, tactics and oversight regarding advancing the development and commercialization of the companies’ drug pipelines, including, but not limited to, Mytesi® and SB-300. From 2006 to 2013, Dr. Chaturvedi served as Napo's Chief Scientific Officer and has remained a scientific adviser to the company since 2014. His track record of successful development includes participating in and/or leading development efforts for seven drugs, including Napo’s Mytesi® (crofelemer) product, which is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. For this indication, Dr. Chaturvedi led the key opinion leader efforts that contributed to the successful use of adaptive clinical trial design for the Mytesi® pivotal trial and its approval by the FDA. As announced March 31, 2017, Napo and Jaguar have entered a definitive merger agreement. Napo and Jaguar are in the process of evaluating potential follow-on indications for Mytesi® as part of the anticipated combination of the product pipelines of the two companies. Dr. Chaturvedi is chairing the investigation of Mytesi® for possible follow-on indications, which include chemotherapy-induced diarrhea, irritable bowel syndrome (IBS), for which proof of concept data is already in hand, inflammatory bowel diseases (IBD) and diarrhea resulting from hospital-acquired infections such as Clostridium difficile, a bacterium that is the most common cause of infectious diarrhea in hospital settings. Napo recently convened a Scientific Advisory Board meeting with expert gastroenterologists, who provided advice on study populations and designs in IBS and IBD. As Douglas Drossman, MD, Professor Emeritus at the University of North Carolina, who is a gastroenterologist in private practice at Drossman Gastroenterology, noted, “The safety profile of crofelemer constitutes an advantage that differentiates it from many other gastrointestinal products.” Mytesi® is also being explored for treatment of important orphan gastrointestinal indications such as congenital diarrheal disorders (CDD) and diarrhea associated with short-bowel syndrome (SBS). CDDs are a group of rare, chronic intestinal channel diseases characterized by large, watery stools containing an excess of chloride and sodium, lifelong diarrhea, and a lifelong need for nutritional intake with a feeding tube. CDDs are related to specific genetic defects inherited as autosomal recessive traits, and the incidence of CCDs is much more prevalent in regions where consanguineous marriage is part of the culture. Patients with SBS are born with a substantial shortening of the small intestine, to a mean length of 50 cm, compared with a normal length at birth of 190-280 cm. This could be due to either a genetic disorder or pre-mature birth. In regions such as the United Arab Emirates and Saudi Arabia, both CDD and SBS occur with much higher incidence. Napo has recently visited with medical centers in this region. “With the early and extreme morbidity and mortality suffered by CDD and SBS patients, we welcome the opportunity to participate in the investigation of a novel drug to address the devastating diarrhea and dehydration caused by these lifelong diseases for which there is currently no available treatment except parenteral nutrition, and help limit the suffering of patients and their family members,” stated Dr. Mohamad Miqdady, Chief of Pediatric Gastroenterology, Hepatology & Nutrition at Sheikh Khalifa Medical City in Abu Dhabi. Dr. Chaturvedi is also providing oversight for development of Napo’s proprietary second-generation anti-secretory agent for cholera—a possible indication that may present Napo with an opportunity for an FDA tropical disease priority review voucher. Under FDA regulations, the sponsor of a human drug application for a qualified tropical disease may be eligible for a priority review voucher, which can be used to obtain priority review for any subsequent human drug application submitted to FDA. These vouchers, which are transferable, have recently sold for $125 million - $350 million, and provide an immediate return on investment for the development of a novel product for important indications. “I am thrilled to be supporting Napo’s and Jaguar’s shared mission to change the global standard of care for gastrointestinal diseases,” stated Dr. Chaturvedi. “I look forward to evaluating potential multiple follow-on gastrointestinal indications for Mytesi®, and leveraging the collective expertise of our team in advancing drug development through innovative approaches such as the adaptive clinical trial design that led to the FDA approval of Mytesi® for its current indication of treating noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.” “We are very pleased that Dr. Chaturvedi has returned to support these principal development activities,” Conte commented, “which, if approved, will complement our current sales of Mytesi® for noninfectious diarrhea in adult HIV/AIDS patients on antiretroviral therapy. We consider Mytesi® a ‘pipeline within a product’, and Napo has global unencumbered rights to this novel first-in-class anti-secretory agent with multiple potential follow-on indications.” Dr. Chaturvedi has co-founded and led multiple biotech enterprises including Scion, IndUS and Oceanyx, and has served as the CEO or CSO for Scion, IndUS, Napo, and Oceanyx and is the CEO for Pivot Pharmaceuticals. Over his career, Dr. Chaturvedi led discovery and/or development activities for several new chemical entities (NCEs) and has participated in the discovery and/or development of novel drugs for treatment of HIV, hepatitis C, epilepsy and Alzheimer's disease. Earlier in his career, Dr. Chaturvedi was head of lead evaluation at Vertex Pharmaceuticals and was in the preclinical group at Alkermes. He started his career in the product development group at Parke-Davis/Warner-Lambert Company (now Pfizer). Dr. Chaturvedi holds a Ph.D. in Pharmaceutical Sciences from West Virginia University and a Bachelor's in Pharmacy from the University of Bombay. The proposed merger of Jaguar and Napo remains subject to customary conditions to closing. Upon the consummation of the merger, Jaguar’s name will be changed to Jaguar Health, Inc., and Napo will operate as a wholly-owned subsidiary of Jaguar, focused on human health. Subject to the conditions to closing, the proposed merger is expected to close by the end of July 2017. Mytesi® (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi®. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). More information and complete Prescribing Information are available at Mytesi.com. Crofelemer, the active ingredient in Mytesi®, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity. San Francisco-based Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners. For more information, please visit www.napopharma.com. Jaguar Animal Health, Inc. is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses. Canalevia™ is Jaguar’s lead prescription drug product candidate, intended for the treatment of various forms of diarrhea in dogs. Equilevia™ (formerly referred to as SB-300) is Jaguar’s prescription drug product candidate for the treatment of gastrointestinal ulcers in horses. Canalevia™ and Equilevia™ contain ingredients isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm™ Calf and Neonorm™ Foal are the Company’s lead non-prescription products. Neonorm™ is a standardized botanical extract derived from the Croton lechleri tree. Canalevia™ and Neonorm™ are distinct products that act at the same last step in a physiological pathway generally present in mammals. Jaguar has nine active investigational new animal drug applications, or INADs, filed with the FDA and intends to develop species-specific formulations of Neonorm™ in six additional target species, formulations of Equilevia™ in horses, and Canalevia™ for cats and dogs. For more information about Jaguar, please visit www.jaguaranimalhealth.com. Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the development, approval and sales of potential follow-on indications of Mytesi®, the proposed merger between Jaguar and Napo, Jaguar’s intention to develop species-specific formulations of Neonorm™ in additional target species, and the Company’s plan to develop formulations of Canalevia™ for cats, horses and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.


NEW YORK--(BUSINESS WIRE)--Time Inc.’s (NYSE:TIME) Fortune and the University of North Carolina Kenan-Flagler Business School (UNC Kenan-Flagler) are working together to create new online programs for business leaders scheduled to launch in fall 2017. “Fortune creates powerful content and experiences for its audiences across all platforms, and this is a unique opportunity to engage with business leaders in a new way,” said Alan Murray, Chief Content Officer of Time Inc. and President of Fortune. “UNC Kenan-Flagler disrupted the business education market with the launch of its online MBA program, and we look forward to working together to expand their innovative approach to learning to reach businesspeople wherever they are working.” Programs will be designed for both emerging and mid-level business leaders by UNC Executive Development and taught by UNC Kenan-Flagler professors. The programs will incorporate Fortune’s video content, including interviews with Fortune 500 executives. “Collaborating with Time Inc.’s Fortune—which has a tradition of excellence in business content and connecting leaders to address important topics—is a natural fit for us,” said Douglas A. Shackelford, Dean of UNC Kenan-Flagler. “Through our partnership, we will offer a valuable blend of expertise and access for busy executives who are eager to develop their business expertise and need the flexibility of online learning.” Executives who successfully complete the programs will have the opportunity to earn certificates from the business school. The first certificate program is titled “Leading With Purpose.” Time Inc. (NYSE:TIME) is a leading content company that engages over 170 million consumers every month through our portfolio of premium brands across platforms. By combining our distinctive content with our proprietary data and people-based targeting, we offer highly differentiated end-to-end solutions to marketers across the multimedia landscape. Our influential brands include People, Time, Fortune, Sports Illustrated, InStyle, Real Simple and Southern Living, as well as approximately 50 diverse titles in the United Kingdom. Time Inc. has been extending the power of our brands through various acquisitions and investments, including Viant, an advertising technology firm with a specialized people-based marketing platform; The Foundry, Time Inc.’s creative lab and content studio; and the People Entertainment Weekly Network (PEN). The company is also home to celebrated events, such as the Time 100, Fortune Most Powerful Women, People’s Sexiest Man Alive, Sports Illustrated’s Sportsperson of the Year, the Essence Festival and the Food & Wine Classic in Aspen. The University of North Carolina at Chapel Hill, the nation’s first public university, is a global higher education leader known for innovative teaching, research and public service. Consistently ranked one of the world's best business schools, UNC Kenan-Flagler Business School is known for its collaborative culture, which stems from its core values: excellence, leadership, integrity, community and teamwork. Professors excel at both teaching and research, and demonstrate unparalleled dedication to students. Graduates are effective, principled leaders who have the technical and managerial skills to deliver results in the global business environment. UNC Kenan-Flagler offers a rich portfolio of programs and extraordinary, real-life learning experiences: Undergraduate Business, MBA, Master of Accounting, PhD and Executive Development Programs. It is home to the Frank Hawkins Kenan Institute of Private Enterprise.


News Article | May 10, 2017
Site: globenewswire.com

DURHAM, N.C., May 10, 2017 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today provided an update on the ADAPT trial, a randomized, active controlled, open-label, multi-center Phase 3 trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma (mRCC), following a meeting with the FDA. As previously reported, the Company has continued to conduct the ADAPT trial notwithstanding the recommendation by the Independent Data Monitoring Committee in February 2017 to terminate the trial for futility. In making this determination, Argos considered, among other factors, the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of a long-term memory immune response, and the IDMC's assessment of the safety profile of Rocapuldencel-T. Of note, at the time of the IDMC's February interim analysis, the median duration of follow-up was 20.0 months and more than half the patients in both treatment groups were still alive. The Company submitted information related to its analysis of the interim data to the FDA and met with the FDA to discuss the future direction of the ADAPT trial and the Rocapuldencel-T development program. Participating in the meeting along with representatives from the Company were Robert Figlin, MD, Chairman of Hematology Oncology and Professor of Medicine, Cedars Sinai Medical Center; Nizar Tannir, MD, Professor and Deputy Chairman, Department of Genitourinary Medical Oncology, MD Anderson Cancer Center; and Gary Koch, PhD, Professor of Biostatistics, University of North Carolina. The FDA agreed with the Company’s plan to continue the trial in accordance with the current protocol to 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted. The Company believes that 290 events will have occurred by late 2017 or early 2018. The Company also proposed to submit, and the FDA agreed to review, a protocol amendment to increase the pre-specified number of events for the primary analysis of overall survival beyond 290 events, which the Company believes could enhance its ability to detect whether Rocapuldencel-T has a delayed treatment effect. The Company can extend the study past 290 events without needing to enroll additional patients. As previously reported, the Company has analyzed interim data from a predefined subset of patients who demonstrated an immune response to Rocapuldencel-T at 48 weeks, whose immune response is consistent with the mechanism of action of the therapy and correlates with survival, suggesting that the treatment is biologically active. Analysis of the data from the ADAPT trial, including immune response data, remains ongoing. The Company expects to provide further updates on the future direction of the ADAPT trial and the Rocapuldencel-T program following further analysis of the data from the trial and further discussions with the FDA. “We are pleased to be able to continue the ADAPT trial,” noted Robert Figlin, MD, principal investigator for the trial. “We believe that Rocapuldencel-T may offer patients and their physicians an important new option for the treatment of mRCC, a disease that remains an area of high unmet medical need. By amending the protocol to extend the ADAPT trial, we believe we can potentially increase the likelihood of detecting a treatment effect, if one exists, given that immunotherapy is expected to result in a delayed treatment effect. We appreciate the collaborative efforts of the FDA as we seek to determine the potential utility of Rocapuldencel-T in the treatment of this difficult disease.“ “We remain committed to the clinical development of Rocapuldencel-T, and look forward to providing additional updates on the ADAPT trial and the Rocapuldencel-T development program moving forward,” noted Jeff Abbey, CEO of Argos. “We appreciate the continued commitment of the investigators and patients in the ADAPT trial as we continue to explore the potential benefit of this unique therapy.” Arcelis® is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient's individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis® process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient's own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient's plasma, and administered via intradermal injection as an individualized immunotherapy. Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, Rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). In addition, Rocapuldencel-T is being studied in a Phase 2 investigator-initiated clinical trial as neoadjuvant therapy for renal cell carcinoma (RCC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Any statements in this press release about Argos' future expectations, plans and prospects, including statements about the ADAPT trial and the interim data from the trial, Argos' anticipated discussions with the FDA, clinical development of Argos' product candidates and future expectations and plans and prospects for Argos and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund its continuing operations for the periods anticipated and through completion of the trial; the impact of the planned analysis of the data and discussions with the FDA on the development of Rocapuldencel-T; the impact of the recommendation of the IDMC on the continuation of the ADAPT trial; whether preliminary or interim clinical data such as the interim data referenced in this release will be indicative of the final data from a clinical trial; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Argos' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether Argos can successfully establish commercial manufacturing operations on a timely basis or at all; and other factors discussed in the "Risk Factors" section of Argos' Form 10-K for the year ended December 31, 2016, which is on file with the SEC, and in other filings Argos makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Argos' views as of the date hereof. Argos anticipates that subsequent events and developments will cause Argos' views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos' views as of any date subsequent to the date hereof.


News Article | May 10, 2017
Site: globenewswire.com

DURHAM, N.C., May 10, 2017 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today provided an update on the ADAPT trial, a randomized, active controlled, open-label, multi-center Phase 3 trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma (mRCC), following a meeting with the FDA. As previously reported, the Company has continued to conduct the ADAPT trial notwithstanding the recommendation by the Independent Data Monitoring Committee in February 2017 to terminate the trial for futility. In making this determination, Argos considered, among other factors, the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of a long-term memory immune response, and the IDMC's assessment of the safety profile of Rocapuldencel-T. Of note, at the time of the IDMC's February interim analysis, the median duration of follow-up was 20.0 months and more than half the patients in both treatment groups were still alive. The Company submitted information related to its analysis of the interim data to the FDA and met with the FDA to discuss the future direction of the ADAPT trial and the Rocapuldencel-T development program. Participating in the meeting along with representatives from the Company were Robert Figlin, MD, Chairman of Hematology Oncology and Professor of Medicine, Cedars Sinai Medical Center; Nizar Tannir, MD, Professor and Deputy Chairman, Department of Genitourinary Medical Oncology, MD Anderson Cancer Center; and Gary Koch, PhD, Professor of Biostatistics, University of North Carolina. The FDA agreed with the Company’s plan to continue the trial in accordance with the current protocol to 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted. The Company believes that 290 events will have occurred by late 2017 or early 2018. The Company also proposed to submit, and the FDA agreed to review, a protocol amendment to increase the pre-specified number of events for the primary analysis of overall survival beyond 290 events, which the Company believes could enhance its ability to detect whether Rocapuldencel-T has a delayed treatment effect. The Company can extend the study past 290 events without needing to enroll additional patients. As previously reported, the Company has analyzed interim data from a predefined subset of patients who demonstrated an immune response to Rocapuldencel-T at 48 weeks, whose immune response is consistent with the mechanism of action of the therapy and correlates with survival, suggesting that the treatment is biologically active. Analysis of the data from the ADAPT trial, including immune response data, remains ongoing. The Company expects to provide further updates on the future direction of the ADAPT trial and the Rocapuldencel-T program following further analysis of the data from the trial and further discussions with the FDA. “We are pleased to be able to continue the ADAPT trial,” noted Robert Figlin, MD, principal investigator for the trial. “We believe that Rocapuldencel-T may offer patients and their physicians an important new option for the treatment of mRCC, a disease that remains an area of high unmet medical need. By amending the protocol to extend the ADAPT trial, we believe we can potentially increase the likelihood of detecting a treatment effect, if one exists, given that immunotherapy is expected to result in a delayed treatment effect. We appreciate the collaborative efforts of the FDA as we seek to determine the potential utility of Rocapuldencel-T in the treatment of this difficult disease.“ “We remain committed to the clinical development of Rocapuldencel-T, and look forward to providing additional updates on the ADAPT trial and the Rocapuldencel-T development program moving forward,” noted Jeff Abbey, CEO of Argos. “We appreciate the continued commitment of the investigators and patients in the ADAPT trial as we continue to explore the potential benefit of this unique therapy.” Arcelis® is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient's individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis® process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient's own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient's plasma, and administered via intradermal injection as an individualized immunotherapy. Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, Rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). In addition, Rocapuldencel-T is being studied in a Phase 2 investigator-initiated clinical trial as neoadjuvant therapy for renal cell carcinoma (RCC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Any statements in this press release about Argos' future expectations, plans and prospects, including statements about the ADAPT trial and the interim data from the trial, Argos' anticipated discussions with the FDA, clinical development of Argos' product candidates and future expectations and plans and prospects for Argos and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund its continuing operations for the periods anticipated and through completion of the trial; the impact of the planned analysis of the data and discussions with the FDA on the development of Rocapuldencel-T; the impact of the recommendation of the IDMC on the continuation of the ADAPT trial; whether preliminary or interim clinical data such as the interim data referenced in this release will be indicative of the final data from a clinical trial; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Argos' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether Argos can successfully establish commercial manufacturing operations on a timely basis or at all; and other factors discussed in the "Risk Factors" section of Argos' Form 10-K for the year ended December 31, 2016, which is on file with the SEC, and in other filings Argos makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Argos' views as of the date hereof. Argos anticipates that subsequent events and developments will cause Argos' views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos' views as of any date subsequent to the date hereof.


Matera A.G.,University of North Carolina | Wang Z.,University of North Carolina at Chapel Hill
Nature Reviews Molecular Cell Biology | Year: 2014

One of the most amazing findings in molecular biology was the discovery that eukaryotic genes are discontinuous, with coding DNA being interrupted by stretches of non-coding sequence. The subsequent realization that the intervening regions are removed from pre-mRNA transcripts via the activity of a common set of small nuclear RNAs (snRNAs), which assemble together with associated proteins into a complex known as the spliceosome, was equally surprising. How do cells coordinate the assembly of this molecular machine? And how does the spliceosome accurately recognize exons and introns to carry out the splicing reaction? Insights into these questions have been gained by studying the life cycle of spliceosomal snRNAs from their transcription, nuclear export and re-import to their dynamic assembly into the spliceosome. This assembly process can also affect the regulation of alternative splicing and has implications for human disease. © 2014 Macmillan Publishers Limited.

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