News Article | May 12, 2017
With the arrival of spring — and allergy season — Mediaplanet today announces the launch of this May’s edition of “Asthma & Allergies.” This campaign will encourage readers to take the first steps in identifying and treating allergies and asthma as well as learning how to better manage these chronic illnesses and continue to live an active life. Allergic disease, which includes asthma, is the fifth-leading chronic disease in the U.S. across all age groups. It is also the third-most common chronic disease in children under 18 years old. Allergies are on the rise and currently affect as many as 30 percent of adults and 40 percent of children. The print component of “Asthma & Allergies” is distributed within today’s edition of USA Today in Chicago, Los Angeles, Boston, New York and Philadelphia markets, with a circulation of approximately 250,000 copies and an estimated readership of 750,000. The digital component is distributed nationally, through a vast social media strategy, and across a network of top news sites and partner outlets. To explore the digital version of the campaign, click here. This campaign was made possible with the support of the American College of Allergy, Asthma and Immunology; American Academy of Allergy, Asthma & Immunology; Allergy and Asthma Network; New York Allergy & Asthma Society; Asthma and Allergy Foundation of America; IQAir; Airmega; PURE; Protect-A-Bed; De'Longhi; Field Controls; Church & Dwight; and Quest Diagnostics. About Mediaplanet Mediaplanet specializes in the creation of content marketing campaigns covering a variety of industries. We tell meaningful stories that educate our audience and position our clients as solution providers. Our unique ability to pair the right leaders with the right readers, through the right platforms, has made Mediaplanet a global content marketing powerhouse. Our award-winning stories have won the hearts of countless readers while serving as a valuable platform for brands and their missions. Just call us storytellers with a purpose. Please visit http://www.mediaplanet.com for more on who we are and what we do.
News Article | May 8, 2017
BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing CODIT™ (Characterized Oral Desensitization ImmunoTherapy) treatments for life-threatening food allergies, today announced financial results for first quarter 2017. As of March 31, 2017, cash, cash equivalents and investments totaled $259.3 million. “ We continue to be very pleased with progress in PALISADE, our core Phase 3 trial of AR101 for peanut allergy, and we look forward to expanding our Phase 3 program with initiation of the RAMSES trial in the second quarter and the ARTEMIS trial around mid-year,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “ At AAAAI earlier this year, we reported interesting new data from the PALISADE screening population, which support our thesis for RAMSES whereby omitting the oral food challenge may further improve tolerability of AR101 during up-dosing. The level of interest and enthusiasm in our clinical trials remains very high, and we are pleased that most of the study sites in PALISADE will also participate in RAMSES.” Dr. Dilly continued, “ Over the first quarter, we also made key senior management hires focused on defining our path to market and initiating activities to plan for a potential commercial launch of AR101. In addition, as recently announced, we are delighted to have Eric Bjerkholt now on board as CFO. We continue to have substantial financial resources, and I look forward to reporting on our progress in the months ahead.” Reported new AR101 clinical data at AAAAI. In March, Aimmune reported new clinical data at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting showing 95% adherence to daily at-home dosing with AR101 (Phase 2 data) and underscoring a high need for therapy based on 583 patients screened for PALISADE in North America. A subset analysis also showed that the oral food challenge appears to prime the immune system prior to treatment as the percent of activated CD4+ effector T cells were significantly higher after individuals underwent the oral food challenge as compared to their pre-challenge levels. This finding supports the design of the RAMSES trial, which does not require an oral food challenge. Appointed healthcare industry veteran Eric Bjerkholt as CFO. In April, Aimmune announced the appointment of Eric Bjerkholt as CFO. Mr. Bjerkholt was most recently CFO at Sunesis Pharmaceuticals, Inc., where he oversaw multiple aspects of governance, corporate relations, and other functions. Prior to Sunesis, he was CFO at IntraBiotics Pharmaceuticals, Inc., and LifeSpring Nutrition, Inc. Mr. Bjerkholt began his healthcare career at J.P. Morgan & Co. as an investment banker in New York and then launched the company’s Western U.S. healthcare practice. Cash, cash equivalents, and investments totaled $259.3 million at March 31, 2017, compared to $282.5 million at December 31, 2016. The decrease primarily reflects cash used in operations. Net loss was $25.9 million in the first quarter of 2017, compared to a net loss of $15.5 million for the comparable period in 2016. On a per share basis, net loss for the first quarter of 2017 was $0.52, compared to net loss per share of $0.37 for the comparable period in 2016. The weighted average shares outstanding for the quarter were 50.1 million, compared to 41.7 million for the comparable period in 2016. Research and development expenses for the first quarter of 2017 were $17.4 million, compared to $10.0 million for the comparable period in 2016. The increase was primarily due to increased clinical trial and contract manufacturing costs and additional personnel-related costs, including stock-based compensation expense, to support the AR101 clinical development program. General and administrative expenses for the first quarter of 2017 were $8.9 million, compared to $5.7 million for the comparable period in 2016. The increase was primarily due to additional personnel-related costs, including stock-based compensation expense, to support the achievement of the company’s goals. Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age and is currently being evaluated in Phase 3 clinical trials. For more information, please see www.aimmune.com. Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s expectations for its Phase 3 PALISADE trial of AR101; Aimmune’s expectations for its RAMSES and ARTEMIS trials, including the timing of initiation of each trial; Aimmune’s expectation that the absence of a food challenge in the RAMSES trial could improve tolerability of AR101; Aimmune’s expectations regarding the potential benefits of AR101; Aimmune’s expectations regarding the sufficiency of its capital resources; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; the company’s ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s clinical trials will not be successful; Aimmune’s dependence on the success of AR101; the company’s reliance on third parties for the manufacture of the company’s product candidates; possible regulatory developments in the United States and foreign countries; and the company’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune's most recent filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. This press release concerns a product that is under clinical investigation and that has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). It is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated. (1) Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended December 31, 2016.
News Article | April 19, 2017
The Clinical Research Forum, a national organization of senior researchers and thought leaders from the nation's leading academic health centers, selected two studies headed by University of Chicago researchers as among the three best clinical research papers published in 2016. These awards honor outstanding clinical research and identify major advances resulting from the nation's investment in improving the health of its citizens. Ten award winners were chosen for their innovation and creativity, advancement of science in a specific area, contribution to understanding human disease or physiology, and potential impact upon the diagnosis, prevention and treatment of disease. The Herbert Pardes Clinical Research Excellence Award is the Clinical Research Forum's highest honor. It is awarded to the research study that best exemplifies the spirit of the awards in that it shows a team science approach with a high degree of innovation and creativity, which advances science and has an impact upon human disease. The award comes with a cash prize of $5,000. This year, the Pardes Award went to a team headed by geneticist Carole Ober, PhD, professor and chairman of human genetics at the University of Chicago, and immunologist Anne Sperling, PhD, associate professor of medicine at the University of Chicago. Their study, "Innate Immunity and Asthma Risk in Amish and Hutterite Farm Children," was published Aug. 4, 2016, in the New England Journal of Medicine. The interdisciplinary team of researchers showed that substances in the house dust from Amish, but not Hutterite, homes were able to engage and shape the innate immune system (the body's front-line response to most microbes) in young Amish, but not Hutterite, children in ways that appear to suppress pathologic responses leading to allergic asthma. The Distinguished Clinical Research Achievement Awards are presented to the top two studies that demonstrate creativity, innovation, or a novel approach that demonstrates an immediate impact on the health and well-being of patients. These awards come with a cash prize of $3,500. One of those awards goes to a team led by pulmonologist John P. Kress, MD, professor of medicine at the University of Chicago, and Bhakti Patel, MD, clinical instructor of medicine at the University. Their study on the "Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial," was published May 15, 2016, in JAMA. It showed that using a transparent, air-tight helmet instead of a face mask helps critically ill patients breathe better and can prevent them from needing a ventilator. Patients with helmet ventilation had better survival and spent less time in the intensive care unit. The helmet "confers several advantages over the face mask," the authors note. It is less likely to leak. This enables the care team to increase air pressure into the helmet, which helps keep the airway and lungs open and improves oxygen levels. It is also more comfortable, easier to tolerate because it doesn't touch the face, and patients can see through it well enough to watch television, talk or read. Award recipients were recognized earlier this evening at the Clinical Research Forum's sixth annual awards ceremony on April 18 at the National Press Club in Washington, D.C. Members of the research teams will visit congressional representatives on Capitol Hill on Wednesday, April 19, to brief officials on their findings and the critical and necessary role of federal funding for clinical research. These studies reflect major work being conducted at nearly 60 research institutions and hospitals across the United States, as well as at partner institutions from around the world, according to the Clinical Research Forum. "The 2017 awardees represent the enormous potential that properly funded research can have on patients and the public," said Harry P. Selker, MD, MSPH, Chairman of the CR Forum Board of Directors. "It is our hope that the significance of these projects and their outcomes can help educate the public, as well as elected officials, on the important impact of clinical research on human health." Recognizing the need to celebrate our nation's clinical research accomplishments that involve both innovation and impact on human disease, the Clinical Research Forum conducts an annual competition to determine the ten outstanding research accomplishments in the United States. These major research advances represent a portion of the annual return on the nation's investment in the health and future welfare of its citizens. The mission of the Clinical Research Forum is to provide leadership to the national and clinical translational research enterprise and promote understanding and support for clinical research and its impact on health and healthcare. For more information, visit http://www. . The National Institutes of Health, the St. Vincent Foundation and the American Academy of Allergy, Asthma & Immunology Foundation supported the asthma study. Additional authors were Michelle Stein, Cara Hrusch, Catherine Igartua and Jack Gilbert from the University of Chicago; Donata Vercelli, Justyna Gozdz, Vadim Pivniouk, Julie Ledford, Mauricius Marques dos Santos, Julia Neilson, Sean Murray, Raina Maier and Fernando Martinez from the University of Arizona; Erika von Mutius of the Dr. von Hauner Children Hospital in Munich, Germany; Nervana Metwali and Peter Thorne from the University of Iowa; and Mark Holbreich, an allergist-immunologist in Indianapolis, Indiana. Funding for the helmet study was supplied by the National Heart Lung and Blood Institute. The helmets were purchased using funds from an unrestricted grant from the Daniel J. Edelman family. Additional authors were Krysta Wolfe, Anne Pohlman and Jesse Hall, all from the University of Chicago.
News Article | March 1, 2017
-- Poster Session 4213 on Monday, March 6 from 9:45 am to 10:45 am NEW YORK, March 01, 2017 (GLOBE NEWSWIRE) -- Attune Pharmaceuticals, a biotechnology company focused on the discovery and development of novel oral small molecule therapeutics for treatment of rare diseases, announced today that the Company will present new data for ATN-249 in a late-breaking poster at the 2017 American Academy of Allergy, Asthma & Immunology Annual Meeting (AAAAI 2017). The poster presentation highlights potency, selectivity, pharmacokinetic, and safety attributes of ATN-249, a novel orally administered plasma kallikrein inhibitor for the treatment Hereditary Angioedema (HAE). Preclinical studies demonstrated ATN-249 was highly selective and potent at plasma kallikrein inhibition in both biochemical and contact activation assays. Pharmacokinetic data support once daily administration with a wide therapeutic index. The poster will be presented at the Late Breaking Poster Session 4213 on Monday, March 6 from 9:45 am to 10:45 am in Georgia World Congress Center, Building B Exhibit Hall B2. Each poster will remain on display throughout the day until 6:00pm. AAAAI 2017 will be held at Georgia World Congress Center, 285 Andrew Young International Blvd NW, Atlanta, GA, from Friday, March 3, 2017 through Monday, March 6, 2017. Details for the poster presentation: Title: Potency, Selectivity, and Exposure Evaluation of ATN-249, a New Oral Kallikrein Inhibitor for Hereditary Angioedema Downloadable copies of the abstract are available in the February 2017 online supplement to The Journal of Allergy and Clinical Immunology: http://www.jacionline.org/article/S0091-6749(16)32423-X/abstract About Hereditary Angioedema Hereditary angioedema (HAE) is a rare, potentially life-threatening disease characterized by acute skin and mucosal edema. It is caused by an autosomal dominant mutation of the SERPING1 or F12 genes, resulting in affected C1 inhibitor protein. Dysregulation of the C1 pathway from non-functional C1 inhibitor then causes upregulation of bradykinin production, leading to increased vascular permeability, recurrent abdominal pain, and swelling, which can be fatal if it involves the larynx. Current treatments are limited by route of administration and adverse events, since all conventional C1 pathway-specific drugs are administered intravenously or subcutaneously, and may be associated with drug-specific adverse effects. About Attune Pharmaceuticals Attune Pharmaceuticals is a pre-clinical stage biotechnology focused on the discovery and development of novel oral once-daily small molecule therapeutics for treatment of rare diseases. Attune Pharmaceuticals is currently developing 2 programs in rare diseases: Hereditary angioedema (HAE) and complement-mediated diseases. Attune Pharmaceuticals has identified ATN-249 as a lead candidate to treat HAE and will begin clinical testing in 2017. About ATN-249’s Clinical Development Program ATN-249 was designed as a novel, potent, selective, and orally-administered plasma kallikrein inhibitor for the treatment of Hereditary Angioedema (HAE) by blocking kallikrein-mediated production of bradykinin. Preclinical studies in both biochemical and contact activation assays have demonstrated that ATN-249 is highly selective and potent at plasma kallikrein inhibition. ATN-249 has been evaluated in several pharmacokinetic and toxicological studies in multiple species. Given its observed wide therapeutic window and once-daily dosing potential, these preclinical results suggest that ATN-249 may be a potent, safe, orally-administered plasma kallikrein inhibitor for the treatment of HAE.
News Article | February 27, 2017
BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing CODIT™ (Characterized Oral Desensitization ImmunoTherapy) treatments for life-threatening food allergies, today announced that new clinical data on AR101 will be presented during poster sessions on Monday, March 6, at the 2017 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting taking place March 3–6, 2017, in Atlanta, Georgia. The presentations will report data from the Phase 2 ARC001 study (Abstract 803) and from the screening population of the PALISADE Phase 3 study (Abstracts L20 and 807). Presentation details are as follows: Abstract 803: Jones S, et al., At-home dosing adherence during characterized oral desensitization immunotherapy (CODIT) for peanut allergy; Poster Session #4210 on Allergen Extracts and Other Forms of Immunotherapy, 9:45 AM – 10:45 AM Eastern Time, Monday, March 6, 2017, in Building B, Level 1, Exhibit Hall B2. The abstract may be viewed online at http://www.jacionline.org/article/S0091-6749(16)32342-9/pdf. Abstract L20: Vickery BP, et al., Outcome of 583 entry double-blind placebo-controlled peanut challenges during screening for the PALISADE Phase 3 oral immunotherapy trial; Late Breaking Poster Session #4213, 9:45 AM - 10:45 AM Eastern Time, Monday, March 6, 2017, in Building B, Level 1, Exhibit Hall B2. The abstract may be viewed online at http://www.jacionline.org/article/S0091-6749(16)32432-0/pdf. Abstract 807: Rust B, et al., Dual assessment of peanut-specific effector and regulatory T cells in patients undergoing oral immunotherapy; Poster Session #4210 on Allergen Extracts and Other Forms of Immunotherapy, 9:45 AM – 10:45 AM Eastern Time, Monday, March 6, 2017, in Building B, Level 1, Exhibit Hall B2. The abstract may be viewed online at http://www.jacionline.org/article/S0091-6749(16)32346-6/pdf. Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age and is currently being evaluated in Phase 3 clinical trials in ages 4-55. AR101 is a characterized, regulated, oral biological drug product containing the protein profile found in peanuts. For more information, please see www.aimmune.com.
News Article | October 31, 2016
‘Cedar Pollen Allergy - Pipeline Review, H2 2016’, provides an overview of the Cedar Pollen Allergy pipeline landscape. The report provides comprehensive information on the therapeutics under development for Cedar Pollen Allergy, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Cedar Pollen Allergy and features dormant and discontinued projects. Report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. - The report provides a snapshot of the global therapeutic landscape of Cedar Pollen Allergy - The report reviews pipeline therapeutics for Cedar Pollen Allergy by companies and universities/research institutes based on information derived from company and industry-specific sources - The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages - The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved Cedar Pollen Allergy therapeutics and enlists all their major and minor projects - The report assesses Cedar Pollen Allergy therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type - The report summarizes all the dormant and discontinued pipeline projects - The report reviews latest news related to pipeline therapeutics for Cedar Pollen Allergy - Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Identify and understand important and diverse types of therapeutics under development for Cedar Pollen Allergy - Identify potential new clients or partners in the target demographic - Develop strategic initiatives by understanding the focus areas of leading companies - Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics - Devise corrective measures for pipeline projects by understanding Cedar Pollen Allergy pipeline depth and focus of Indication therapeutics - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope - Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline Table of Contents Table of Contents 2 List of Tables 4 List of Figures 4 Introduction 5 Report Coverage 5 Cedar Pollen Allergy Overview 6 Therapeutics Development 7 Pipeline Products for Cedar Pollen Allergy - Overview 7 Pipeline Products for Cedar Pollen Allergy - Comparative Analysis 8 Cedar Pollen Allergy - Therapeutics under Development by Companies 9 Cedar Pollen Allergy - Therapeutics under Investigation by Universities/Institutes 10 Cedar Pollen Allergy - Pipeline Products Glance 11 Late Stage Products 11 Clinical Stage Products 12 Early Stage Products 13 Cedar Pollen Allergy - Products under Development by Companies 14 Cedar Pollen Allergy - Products under Investigation by Universities/Institutes 15 Cedar Pollen Allergy - Companies Involved in Therapeutics Development 16 ALK-Abello A/S 16 Astellas Pharma Inc. 17 Circassia Pharmaceuticals Plc 18 Immunomic Therapeutics, Inc. 19 Japan Tobacco Inc. 20 REGiMMUNE Corporation 21 Cedar Pollen Allergy - Therapeutics Assessment 22 Assessment by Monotherapy Products 22 Assessment by Combination Products 23 Assessment by Target 24 Assessment by Route of Administration 25 Assessment by Molecule Type 27 Drug Profiles 29 ASP-4070 - Drug Profile 29 Product Description 29 Mechanism Of Action 29 R&D Progress 29 Biologic for Cedar Pollen Allergy - Drug Profile 31 Product Description 31 Mechanism Of Action 31 R&D Progress 31 JCC-LAMP-Vax - Drug Profile 32 Product Description 32 Mechanism Of Action 32 R&D Progress 32 RGI-1001 - Drug Profile 33 Product Description 33 Mechanism Of Action 33 R&D Progress 33 standardized mite (Dermatophagoides pteronyssinus + Dermatophagoides farinae) allergen vaccine - Drug Profile 34 Product Description 34 Mechanism Of Action 34 R&D Progress 34 TO-206 - Drug Profile 39 Product Description 39 Mechanism Of Action 39 R&D Progress 39 Vaccine for Cedar Pollen Allergy - Drug Profile 40 Product Description 40 Mechanism Of Action 40 R&D Progress 40 Vaccine for Japanese Cedar Pollen Allergy - Drug Profile 41 Product Description 41 Mechanism Of Action 41 R&D Progress 41 Cedar Pollen Allergy - Dormant Projects 42 Cedar Pollen Allergy - Product Development Milestones 43 Featured News & Press Releases 43 Aug 07, 2015: ALK’s partner for Japan reports positive Phase II/III trial results for Japanese Cedar SLIT-tablet 43 Mar 09, 2015: Immunomic Therapeutics to Present at BIO-Europe Annual Conference 43 Feb 20, 2015: Immunomic Therapeutics to Present Data on Its Proprietary LAMP Vaccine Platform at 2015 American Academy of Allergy, Asthma and Immunology Meeting 43 Apr 24, 2013: Immunomic Therapeutics Announces Interim Data Analysis Of Phase I Study To Treat Japanese Red Cedar Allergy 44 Nov 08, 2012: Immunomic Therapeutics Doses First Patient In Phase I Clinical Trial Of JRC-LAMP-Vax Vaccine To Treat Japanese Red Cedar Allergy 45 Appendix 46 Methodology 46 Coverage 46 Secondary Research 46 Primary Research 46 Expert Panel Validation 46 Contact Us 46 Disclaimer 47 Get It now @ https://www.wiseguyreports.com/checkout?currency=one_user-USD&report_id=711813
News Article | February 24, 2017
The International Association of HealthCare Professionals is pleased to welcome David Wenger-Keller, MD, Family Medicine Physician, to their prestigious organization with his upcoming publication in The Leading Physicians of the World. Dr. David Wenger-Keller is a highly trained and qualified family practitioner with an extensive expertise in all facets of his work, especially fibromyalgia, asthma, and allergies. Dr. Wenger-Keller has been in practice for more than 38 years and is currently serving patients within Fort Madison Physicians and Surgeons in Fort Madison, Iowa. Dr. David Wenger-Keller attended The Medical College of Ohio at Toledo, where he graduated with his Medical Degree in 1978. He subsequently completed his Family Medicine residency within the same educational venue. Dr. Wenger-Keller is certified by the American Board of Family Medicine. To keep up to date with the latest advances and developments in his field, he maintains a professional membership with the American Academy of Allergy, Asthma and Immunology, and the American Academy of Family Physicians. Dr. Wenger-Keller also does emergency medicine working 6-8 shifts monthly, and is the Medical Director of the local hospice, local EMS services, and two area nursing homes. With his wealth of experience and knowledge, Dr. Wenger-Keller teaches medical students from Des Moines University in Des Moines, Iowa. He attributes his success to taking great care of people, being kind, and making a positive difference every day one person at a time. When he is not assisting patients, Dr. Wenger-Keller enjoys cooking, watching movies, and traveling. Learn more about Dr. Wenger-Keller here: http://www.fmchosp.com/ and http://www.docwk.com/ and be sure to read his upcoming publication in The Leading Physicians of the World. FindaTopDoc.com is a hub for all things medicine, featuring detailed descriptions of medical professionals across all areas of expertise, and information on thousands of healthcare topics. Each month, millions of patients use FindaTopDoc to find a doctor nearby and instantly book an appointment online or create a review. FindaTopDoc.com features each doctor’s full professional biography highlighting their achievements, experience, patient reviews and areas of expertise. A leading provider of valuable health information that helps empower patient and doctor alike, FindaTopDoc enables readers to live a happier and healthier life. For more information about FindaTopDoc, visit http://www.findatopdoc.com
News Article | November 8, 2016
DBV Technologies Completes Enrollment of Phase II Study of Viaskin Milk for the Treatment of Milk Allergic Patients Most advanced product candidate for the treatment of IgE-mediated cow's milk allergy in development today FDA Fast Track designation for Viaskin Milk was granted in September 2016 DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), today announced that enrollment for Part B, or Phase II, of the Phase I/II study of Viaskin Milk for the treatment of patients with IgE-mediated cow's milk protein allergy (CMPA) has been completed. The MILES trial is evaluating the efficacy and safety of Viaskin Milk in desensitizing children two to 17 years of age suffering from CMPA. The Viaskin Milk patch is based on DBV's epicutaneous immunotherapy (EPIT), a proprietary technology platform that can deliver biologically active compounds to the immune system through the skin. The blinded part of the MILES study is expected to complete in the second half of 2017. No safety concerns were observed during Part A of the MILES Study (Phase I), for which study results were presented at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Los Angeles, CA, on March 6, by Karine Rutault, Director, Clinical Projects, DBV Technologies. In Phase II, or Part B of the MILES study, a total of 283 patients were screened. The Company expects approximately 176 children with IgE-mediated CMPA will be randomized 1:1:1:1 to receive one of the three doses of Viaskin Milk (150 µg, 300 µg, 500 µg) or placebo for 12 months. "This is an important milestone for the treatment of pediatric CMPA, a disease affecting millions of patients worldwide, who are often times at risk of experiencing life-threatening reactions to undetectable traces of cow's milk protein in their everyday lives," said Dr. Anna Nowak-Wegrzyn, Associate Professor, Pediatrics, Allergy and Immunology at Jaffe Food Allergy Institute, Mount Sinai School of Medicine in New York and the Principal Investigator of the MILES trial at Mount Sinai Medical Center. "CMPA is one of the most common food allergies in children today and we look forward to seeing the results from this groundbreaking trial. Viaskin Milk, if proven safe and effective in clinical trials, could be the first product candidate to offer a potential treatment option for these patients, if approved." About the MILES Study The Viaskin Milk Efficacy and Safety (MILES) trial is a multi-center, double-blind, placebo-controlled, randomized Phase I/II trial to study the safety and efficacy of Viaskin Milk in pediatric patient populations (age two to 17) suffering from IgE-mediated cow's milk protein allergy, or CMPA, with elevated IgE levels related to cow's milk protein. The trial is being conducted in select U.S. and Canadian clinical centers. Part A of the MILES trial has been completed with no safety concerns. Approximately 194 subjects are expected to be randomized for treatment at 17 sites, including 18 subjects from Part A and 176 subjects from Part B, under the proposed amended MILES Part B protocol. Eligible subjects with confirmed IgE-mediated CMPA will perform an initial food challenge at screening with escalating doses of cow's milk proteins. Subjects who display objective symptoms of an allergic response to an eliciting dose of 300 mg cow's milk proteins (approximately 9.4 mL of cow's milk) or below will be randomized in the trial. The primary efficacy endpoint will be the percentage of subjects who are treatment responders after 12 months, defined as subjects who meet at least one of the following criteria: (1) a 10-fold or greater increase in the cumulative reactive dose, or CRD, of cow's milk proteins at month 12 of the food challenge as compared to baseline value in addition to reaching tolerance to at least 144 mg of cow's milk protein (approximately 4.5 mL of milk) or (2) a CRD of cow's milk protein greater than or equal to 1,444 mg (approximately 45 mL of milk) at month 12 of the food challenge. Secondary efficacy endpoints include, among others, the percentage of subjects who are treatment responders at month 24, the mean and median CRD of cow's milk proteins at months 12 and 24 as well as the change in CRD from baseline, the change from baseline in the severity of symptoms elicited during the food challenge from baseline to months 12 and 24, and the change from baseline in quality of life assessments at months 12 and 24. About Viaskin Milk Viaskin Milk is an investigational therapy in development for the treatment of pediatric cow's milk protein allergy (CMPA) and Eosinophilic Esophagitis (EoE). The Viaskin Milk patch is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that can deliver biologically active compounds to the immune system through intact skin without allowing compound passage into the blood. About Cow's Milk Protein Allergy Cow's milk protein allergy (CMPA) is the most common food allergy in infants and young children, affecting 2% to 3% of the general population. Symptoms can include gastrointestinal problems such as vomiting and diarrhea, skin rash, angioedema or rapid swelling of the skin, and anaphylaxis. The only option available for CMPA management is the avoidance of cow's milk, which can lead to issues of dietary imbalance, failure to thrive and poor quality of life. About DBV Technologies DBV Technologies is developing Viaskin®, a proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT®, DBV's method of delivering biologically active compounds to the immune system through intact skin. With this new class of self-administered and non-invasive product candidates, the company is dedicated to safely transforming the care of food allergic patients, for whom there are no approved treatments. DBV's food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human proof-of-concept clinical study of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases. DBV Technologies has global headquarters in Montrouge, France and New York, NY. Company shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and traded on the Nasdaq Global Select Market in the form of American Depositary Shares (each representing one-half of one ordinary share) (Ticker: DBVT). For more information on DBV Technologies, please visit our website: www.dbv-technologies.com Forward Looking Statements This press release contains forward-looking statements, including statements regarding the potential safety and efficacy of Viaskin Milk and statements reflecting management's expectations for clinical development of Viaskin Milk and the commercial potential of Viaskin Milk. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical preclinical results may not be predictive of future clinical trial results, and the risk that historical clinical trial results may not be predictive of future trial results. A further list and description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the French Autorité des Marchés Financiers, the Company's Securities and Exchange Commission filings and reports, including in the Company's Annual Report on Form 20-F for the year ended December 31, 2015 and future filings and reports by the Company. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release, whether as a result of new information, future events or circumstances or otherwise.
News Article | February 26, 2017
Point Pleasant Beach, NJ, February 26, 2017 --( These FPIES guidelines were designed to improve quality and consistency of care for FPIES patients by offering clinicians recommendations for disease diagnosis and management. The guidelines address the following topics: Definition and Clinical Manifestations, Epidemiology, Diagnosis, Gastrointestinal Manifestations, Acute Management, Nutritional Management, Natural History, and Future Needs. The guidelines are the result of a three-year global collaboration led by the International FPIES Association and included the input of more than forty leading FPIES experts. Anna Nowak-Wegrzyn, MD, and Matt Greenhawt, MD, co-chaired the guidelines committee that led the effort to develop clinical questions about the diagnosis and management of FPIES. After extensive literature review and data extraction, draft recommendations were considered by an international expert panel that reached consensus on thirty recommendations. I-FPIES Founder and President Fallon Schultz says, “Dozens of FPIES experts from across the globe volunteered their time and efforts to make the I-FPIES guidelines initiative a reality. These first ever, standard of care guidelines for FPIES will fill a significant clinical gap. And beyond that, the guidelines will highlight opportunities for future research, inform health care coverage policy, and lead to needed educational programs.” The “International Consensus Guidelines for the Diagnosis and Management of Food Protein-Induced Enterocolitis Syndrome” were submitted to and approved by American Academy of Allergy, Asthma, and Immunology (AAAAI) as a Workgroup Report of the Adverse Reactions to Foods Committee. The International FPIES Association has a global dissemination plan in place for the guidelines that includes outreach to various clinician groups, including allergists, gastroenterologists, pediatricians, ER physicians, allied health professionals, nurses, dietitians, as well as parents and relevant advocacy groups. There will also be a national outreach plan to reach every allergist in the United States. For international outreach, the I-FPIES medical advisors and executive board will be traveling to major society meetings to educate providers worldwide, and the guidelines will be made available in multiple languages through the organization's partnerships. To find out more about the FPIES guidelines, visit the I-FPIES website: http://fpies.org/index.php/about-fpies/fpies-guidelines. FPIES is a non-IgE gastrointestinal food allergy that manifests as delayed, profuse vomiting, often with diarrhea, acute dehydration, and lethargy. The most common triggers are milk and soy, but any food, even those thought to be hypoallergenic (e.g., rice and oat), can cause an FPIES reaction. Unlike most food allergies that produce immediate reactions such as swelling and hives, FPIES reactions are delayed and usually begin two hours after ingestion of the trigger food. In some cases, the child will have such an extreme reaction that they go into shock and need to be admitted to the ER for immediate treatment with intravenous fluids. There is currently no cure or standardized treatment for FPIES. Unlike common food allergies, standard skin testing and blood testing for specific IgE allergies are routinely negative in FPIES patients. Early diagnosis and treatment are important for preventing FPIES reactions; however, reaching a diagnosis is often delayed. About I-FPIES The International FPIES Association (I-FPIES) is a 501(c)(3) non-profit organization whose mission is to improve the quality of life for patients and families affected by Food Protein-Induced Enterocolitis Syndrome (FPIES). I-FPIES is a worldwide leader in FPIES awareness and the issues surrounding this condition. We seek to increase awareness by providing educational resources, support services, advocacy, and the development of groundbreaking research through our partnership with the medical community. For more information, please visit www.fpies.org or contact us at email@example.com. Point Pleasant Beach, NJ, February 26, 2017 --( PR.com )-- The International FPIES Association (I-FPIES) is excited to announce the publication of the “International Consensus Guidelines for the Diagnosis and Management of Food Protein-Induced Enterocolitis Syndrome.” An executive summary has been published in The Journal of Allergy and Clinical Immunology (JACI), and the full document is available open access online.These FPIES guidelines were designed to improve quality and consistency of care for FPIES patients by offering clinicians recommendations for disease diagnosis and management. The guidelines address the following topics: Definition and Clinical Manifestations, Epidemiology, Diagnosis, Gastrointestinal Manifestations, Acute Management, Nutritional Management, Natural History, and Future Needs.The guidelines are the result of a three-year global collaboration led by the International FPIES Association and included the input of more than forty leading FPIES experts. Anna Nowak-Wegrzyn, MD, and Matt Greenhawt, MD, co-chaired the guidelines committee that led the effort to develop clinical questions about the diagnosis and management of FPIES. After extensive literature review and data extraction, draft recommendations were considered by an international expert panel that reached consensus on thirty recommendations.I-FPIES Founder and President Fallon Schultz says, “Dozens of FPIES experts from across the globe volunteered their time and efforts to make the I-FPIES guidelines initiative a reality. These first ever, standard of care guidelines for FPIES will fill a significant clinical gap. And beyond that, the guidelines will highlight opportunities for future research, inform health care coverage policy, and lead to needed educational programs.”The “International Consensus Guidelines for the Diagnosis and Management of Food Protein-Induced Enterocolitis Syndrome” were submitted to and approved by American Academy of Allergy, Asthma, and Immunology (AAAAI) as a Workgroup Report of the Adverse Reactions to Foods Committee.The International FPIES Association has a global dissemination plan in place for the guidelines that includes outreach to various clinician groups, including allergists, gastroenterologists, pediatricians, ER physicians, allied health professionals, nurses, dietitians, as well as parents and relevant advocacy groups. There will also be a national outreach plan to reach every allergist in the United States.For international outreach, the I-FPIES medical advisors and executive board will be traveling to major society meetings to educate providers worldwide, and the guidelines will be made available in multiple languages through the organization's partnerships.To find out more about the FPIES guidelines, visit the I-FPIES website: http://fpies.org/index.php/about-fpies/fpies-guidelines.FPIES is a non-IgE gastrointestinal food allergy that manifests as delayed, profuse vomiting, often with diarrhea, acute dehydration, and lethargy. The most common triggers are milk and soy, but any food, even those thought to be hypoallergenic (e.g., rice and oat), can cause an FPIES reaction. Unlike most food allergies that produce immediate reactions such as swelling and hives, FPIES reactions are delayed and usually begin two hours after ingestion of the trigger food. In some cases, the child will have such an extreme reaction that they go into shock and need to be admitted to the ER for immediate treatment with intravenous fluids.There is currently no cure or standardized treatment for FPIES. Unlike common food allergies, standard skin testing and blood testing for specific IgE allergies are routinely negative in FPIES patients. Early diagnosis and treatment are important for preventing FPIES reactions; however, reaching a diagnosis is often delayed.About I-FPIESThe International FPIES Association (I-FPIES) is a 501(c)(3) non-profit organization whose mission is to improve the quality of life for patients and families affected by Food Protein-Induced Enterocolitis Syndrome (FPIES). I-FPIES is a worldwide leader in FPIES awareness and the issues surrounding this condition. We seek to increase awareness by providing educational resources, support services, advocacy, and the development of groundbreaking research through our partnership with the medical community. For more information, please visit www.fpies.org or contact us at firstname.lastname@example.org. Click here to view the list of recent Press Releases from International FPIES Association (I-FPIES)
News Article | March 8, 2016
Home > Press > Arrowhead Presents Promising New Preclinical Data on ARC-F12 at AAAAI 2016 Abstract: Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today presented additional preclinical data suggesting that ARC-F12, an RNAi therapeutic that inhibits the production of Factor XII (F12), has the potential to treat hereditary angioedema and to prevent thrombosis. Data presented in a poster at the 2016 American Academy of Allergy, Asthma & Immunology Annual Meeting (AAAAI), show that ARC-F12 had the desired effects of significantly reduced swelling in a rat model of edema and inhibition of blood clot formation in a mouse model of thrombosis, without the undesired effect of increased bleeding risk. In a carrageenan-induced paw edema model in rats, treatment with ARC-F12 seven days prior to carrageenan challenge led to a significant reduction in edema (p < 0.001). The reduction in swelling in ARC-F12 treated rats is similar to that seen in rats treated with a kallikrein-targeted antibody. This supports Arrowhead's position that F12 inhibition could be an attractive target for the rare genetic disorder, hereditary angioedema (HAE). In a mouse model of thrombosis, a dramatic increase in occlusion times was observed in mice receiving ARC-F12. The time to blood flow occlusion is measured as a clinically relevant indicator of physiological response to F12 knockdown and is a measure of the inhibition of thrombus formation. Further, in multiple relevant models of bleeding risk, ARC-F12 did not cause an increase in bleeding times or bleeding risk. Anticoagulants can be used to reduce thrombus formation and thromboembolism occurrence, but also can cause an increase in serious bleeding risk. ARC-F12 may be able to reduce the risk of blood clot formation, without the undesirable bleeding risk caused by anticoagulants. In vivo studies in wild type mice showed that a single 2 mg/kg dose of ARC-F12 achieved greater than 95% knockdown of F12 levels. In multi-dose primate studies, a 4 mg/kg dose resulted in greater than 90% knockdown with even greater knockdown following subsequent doses. Knockdown was also highly durable with greater than 80% reduction maintained between monthly doses. ARC-F12 appeared to be generally well-tolerated and no drug-related changes in toxicity markers were observed as measured by clinical chemistry and hematologic parameters. F12 is a key component of the contact activation pathway involved in thrombosis and the kinin-kallekrein system involved in angioedema. It is predominantly produced in the liver and circulates in plasma, so Arrowhead believes that it is a uniquely suited target for an RNAi-therapeutic delivered with the proprietary Dynamic PolyconjugateTM (DPCTM) delivery system. Consistent with its process for all of its RNAi-therapeutic candidates, Arrowhead's discovery of ARC-F12 followed a screening funnel process that includes: bioinformatic selection of RNAi trigger sequences; trigger synthesis and in vitro screening; synthesis of cholesterol-RNAi triggers and in vivo screening; multiple iterations of structure-activity relationship (SAR) studies and in vivo screening to assess various chemical modifications to improve RNAi trigger activity; in vivo screening in non-human primates; efficacy testing in disease relevant models; non-GLP toxicology studies; and lastly, the selection of a lead candidate. About ARC-F12 Arrowhead's RNAi-based candidate ARC-F12 is in preclinical development as a potential treatment for factor XII (F12) mediated diseases. Arrowhead sees clear unmet need in hereditary angioedema (HAE) and thromboembolic diseases. The biology of factor 12 as part of the coagulation cascade and the kinin-kallikrein system suggest that its reduction through RNAi may present opportunities in both disease areas. The company is currently conducting studies in order to advance ARC-F12 into clinical trials. About Arrowhead Research Corporation Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary Dynamic Polyconjugate delivery platform to develop targeted drugs based on the RNA interference mechanism that efficiently silences disease-causing genes. Arrowhead's pipeline includes ARC-520 and ARC-521 for chronic hepatitis B virus, ARC-AAT for liver disease associated with alpha-1 antitrypsin deficiency, ARC-F12 for hereditary angioedema and thromboembolic diseases, ARC-LPA for cardiovascular disease, and ARC-HIF2 for renal cell carcinoma. For more information please visit www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company's email list and receive news directly, please visit ir.arrowheadresearch.com/alerts.cfm. Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances. DYNAMIC POLYCONJUGATES is a trademark of Arrowhead Research Corporation. For more information, please click If you have a comment, please us. Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.