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News Article | February 23, 2017
Site: www.eurekalert.org

New Rochelle, NY, February 23, 2017--Overwhelming evidence from the biomedical literature shows that adeno-associated virus 2 (AAV2), a viral vector often used to deliver therapeutic genes, is not associated with cancer and, in fact, may protect against cancer. Despite some previous reports insisting that AAV2 is an oncogenic virus, the preponderance of data indicates that recombinant AAV2 used in gene therapy does not integrate into the host genome increasing the risk of cancer and has anti-tumorigenic properties, as described in an article published in Human Gene Therapy, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the Human Gene Therapy website until March 23, 2017. In the article entitled "AAV Infection: Protection from Cancer," Arun Srivastava, University of Florida College of Medicine, Gainesville, and Barrie Carter, BioMarin Pharmaceutical, Novato, CA, discuss the sometimes contradictory reports on this contentious topic. The authors provide a comprehensive review of the biomedical research examining a link between AAV and tumor formation and conclude that the evidence does not support such a link. Srivastava and Carter also highlight research showing that AAV2 can negatively impact the lifecycles of several other viruses known to be associated with malignancy, such as HIV, hepatitis B virus, papillomaviruses, and adenoviruses. "The estimation of risks from rAAV vectors is a complex exercise. It is particularly complex because AAV is a helper-dependent virus, and thus is often found in nature as a "co-infecting" virus along with other viruses," says Editor-in-Chief Terence R. Flotte, MD, Celia and Isaac Haidak Professor of Medical Education and Dean, Provost, and Executive Deputy Chancellor, University of Massachusetts Medical School, Worcester, MA. "These authors point out that there are substantial data to suggest that naturally occurring AAVs actually protect humans from developing cancer, particularly those cancers that may be caused by the other coexisting viruses." Research reported in this publication was supported by the National Institutes of Health under Public Health Service Award Numbers R01 HL-097088 and R21 EB-015684. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Human Gene Therapy, the Official Journal of the European Society of Gene and Cell Therapy, British Society for Gene and Cell Therapy, French Society of Cell and Gene Therapy, German Society of Gene Therapy, and five other gene therapy societies, is an authoritative peer-reviewed journal published monthly in print and online. Led by Editor-in-Chief Terence R. Flotte, MD, Celia and Isaac Haidak Professor of Medical Education and Dean, Provost, and Executive Deputy Chancellor, University of Massachusetts Medical School, Human Gene Therapy presents reports on the transfer and expression of genes in mammals, including humans. Related topics include improvements in vector development, delivery systems, and animal models, particularly in the areas of cancer, heart disease, viral disease, genetic disease, and neurological disease, as well as ethical, legal, and regulatory issues related to the gene transfer in humans. Its companion journals, Human Gene Therapy Methods, published bimonthly, focuses on the application of gene therapy to product testing and development, and Human Gene Therapy Clinical Development, published quarterly, features data relevant to the regulatory review and commercial development of cell and gene therapy products. Tables of contents for all three publications and a free sample issue may be viewed on the Human Gene Therapy website. Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Nucleic Acid Therapeutics, Tissue Engineering, Stem Cells and Development, and Cellular Reprogramming. Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.


News Article | February 27, 2017
Site: globenewswire.com

Dublin, Feb. 27, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Human Chorionic Gonadotropin Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2012 To 2022" report to their offering. The Human Chorionic Gonadotropin Market Was Estimated at USD 346.3 Mn in 2015, and Is Required to Achieve USD 533.7Mn by 2022 Infertility treatment in both guys and females is the significant treatment territory where HCG is usually managed. Developing rate of fruitlessness in ladies, contributed by expanded maternity age, way of life impacts and others, hormonal dysfunctions in men and developing occurrence of oligospermia are the key elements that have bolstered the interest for HCG sedates in the market. The interest for HCG is unfaltering in created markets of Europe and North America. Then again, developing mindfulness as a rule populace and improvement of medicinal services framework are supporting the development sought after for HCG medicates in developing markets. HCG bolsters the typical advancement of egg in ovary and invigorates egg discharge amid ovulation. It is likewise utilized for fruitlessness treatment as a part of ladies and to enlarge sperm number in men. Young men with undescended gonads are likewise regulated HCG treatment. Hugh commonness of both male and female Infertility issues, extending occurrence of low sperm include and sperm thickness men are is the key variable driving the HCG drugs market. A larger part of the items as of now accessible in the market are characteristic source, i.e. pee inferred HCG. In any case, in perspective of cluster to group irregularity in item immaculateness and prerequisite of vast measure of pee has brought about rise of recombinant creation innovation. North America is relied upon to be the biggest and most potential local market for human chorionic gonadotropin. North America constitutes territorial markets of U.S. what's more, Canada, the rising frequency of fruitlessness cases, way of life impacts and others, hormonal dysfunctions in men and ladies are the real driver for the development of the worldwide human chorionic gonadotropin market. Asia-Pacific is the normal to bethe most potential provincial market for human chorionic gonadotropin market by 2022. Throughout the following six years, the development of the market in the Asia-Pacific area is probably going to be focused in Japan, South Korea, China, and India. The enter players in human chorionic gonadotropin market are EMD Serono, Inc.,Ferring B.V., Merck and Co., Inc., Bristol Myers Squibb Company and Fresenius KabiUSA, LLC. Key Topics Covered: Chapter 1 Preface 1.1 Report Description 1.1.1 Purpose Of The Report 1.1.2 Target Audience 1.1.3 Usp And Key Offerings 1.2 Research Scope 1.3 Research Methodology Chapter 2 Executive Summary 2.1 Global Human Chorionic Gonadotropin Market, By Therapeutic Area, 2015 (USD MN) 2.2 Global Human Chorionic Gonadotropin Market, By Technology, 2015 (USD MN) 2.3 Global Human Chorionic Gonadotropin Market, By Therapeutic Area Market, By Geography, 2015 (Value %) Chapter 3 Global Hematopoietic Stem Cells Market Overview 3.1 Overview 3.2 Market Drivers 3.2.1 High Infertility Prevalence Worldwide 3.3 Market Restraints 3.3.1 Availability Of Substitutes 3.4 Market Opportunities 3.4.1 Demand For Recombinant HCG 3.5 Attractive Investment Proposition 3.6 Market Competition Assessment: Human Chorionic Gonadotropin Market, By Key Players Chapter 4 Global Human Chorionic Gonadotropin Market Analysis, By Treatment 4.1 Overview 4.2 Female Infertility Treatment 4.3 Oligospermia Treatment 4.4 Cryptorchidism Treatment 4.5 Others Chapter 5 Global Human Chorionic Gonadotropin Market Analysis, By Technology 5.1 Overview 5.2 Natural Source Extraction 5.3 Recombinant Dna Technology Chapter 6 Global Human Chorionic Gonadotropin Market, By Geography Chapter 7 Company Profiles Bristol Mayer Squibb Company Emd Serono, Inc. Ferring B.V. Fresenius Kabi Usa, Llc Merck & Co., Inc. For more information about this report visit http://www.researchandmarkets.com/research/lpdpfg/global_human


Osaka, Japon, 17 février 2017, et Louvain, Belgique, 17 février 2017, 9:01 am CET - Takeda Pharmaceutical Company Limited (TSE : 4502) (« Takeda ») et TiGenix NV (Euronext Bruxelles et Nasdaq : TIG) (« TiGenix ») ont annoncé aujourd'hui de nouvelles données issues de l'essai clinique de phase 3 ADMIRE-CD, qui indiquent que le produit expérimental Cx601, une suspension de cellules souches allogéniques dérivées de tissu adipeux (allogenic adipose-derived stem cells, eASC), maintenait une rémission à long terme sur 52 semaines[1] dans le traitement des fistules périanales complexes réfractaires au traitement chez des patients atteints de la maladie de Crohn. Les résultats ont été présentés au 12ème congrès de l'European Crohn's and Colitis Organisation (ECCO). L'essai ADMIRE-CD est un essai de phase 3 randomisé, en double aveugle et contrôlé, conçu pour évaluer l'efficacité et la sécurité d'emploi du produit à l'essai Cx601 dans le traitement des fistules périanales complexes des patients atteints de la maladie de Crohn2. Les patients étaient randomisés pour une administration unique de cellules de Cx601 ou le placebo (contrôle), chacun de ces traitements étant ajouté au traitement standard. Une proportion significativement plus grande de patients dans le groupe Cx601 versus le groupe contrôle a obtenu une rémission combinée à la fois clinique et radiologique[*] (56,3 % et 38,6 % ; p = 0,010), et une rémission clinique (59,2 % et 41,6 % ; p = 0,013) à la semaine 52 dans la population en intention de traiter modifiée (modified intention-to-treat, mITT)1. Parmi ces patients mITT ayant montré une rémission combinée à la semaine 24, un plus grand nombre de patients dans le groupe Cx601 versus groupe contrôle n'ont rapporté aucune rechute à la semaine 52 (75,0 % et 55,9 %)1. Les taux et types d'événements indésirables liés au traitement (non graves et graves) et les arrêts de traitement dus aux événements indésirables sont apparus être  similaires dans les deux groupes (Cx601 : 20,4 % ; contrôle : 26.5 %)1. La maladie de Crohn est une maladie inflammatoire chronique du tractus gastro-intestinal dont on pense qu'elle affecte jusqu'à 1,6 million de personnes en Europe3. Les fistules périanales complexes sont une complication courante des personnes vivant avec la maladie de Crohn, et les options de traitement sont limitées. En 2009, la Commission européenne a accordé au Cx601 la désignation de médicament orphelin pour le traitement des fistules périanales complexes, reconnaissant le caractère invalidant de cette pathologie et le manque d'options thérapeutiques. En mars 2016, TiGenix a annoncé qu'il avait soumis la demande d'autorisation de mise sur le marché (AMM) à l'Agence européenne des médicaments (AEM) pour le Cx601, et une décision de l'AEM est attendue en 2017. De plus, en septembre 2016, le statut de médicament orphelin a été attribué par l'Institut suisse des produits thérapeutiques (Swissmedic) pour le Cx601 pour la pathologie rare de fistules périanales complexes dans la maladie de Crohn4. « La maladie de Crohn avec fistules périanales est difficile à soigner avec les traitements actuellement disponibles, et conduit souvent à des douleurs, gonflement, infection et incontinence. » a déclaré le Dr Asit Parikh, responsable de l'aire thérapeutique gastroentérologie de Takeda. « Les traitements existants sont limités et associés à des complications et un taux d'échec important. Cx601 peut offrir aux patients une option de traitement alternative. » « Ces données mettent en évidence que l'efficacité et la sécurité d'emploi d'une administration unique de Cx601 ont été maintenues durant un an de suivi. » a précisé le Dr Marie Paule Richard, Chief Medical Officer de TiGenix. « Il est également important de noter que la définition de la rémission combinée utilisée dans l'étude ADMIRE-CD, qui comprenait à la fois l'évaluation clinique et l'évaluation radiologique par IRM, est plus stricte que les critères habituellement utilisés dans les essais randomisés antérieurs à grande échelle évaluant les fistules périanales dans la maladie de Crohn, fondés uniquement sur l'évaluation clinique. » Un essai pivot de phase 3 global destiné à l'enregistrement aux États-Unis de Cx601 pour le traitement des fistules périanales complexes devrait être initié par TiGenix en 2017. Aux États-Unis, TiGenix a l'intention de demander une désignation accélérée auprès de l'administration américaine des denrées alimentaires et des médicaments (Food and Drug Administration, FDA), qui pourrait faciliter et accélérer le développement et le procédé d'examen aux États-Unis. L'engagement de Takeda envers la gastro-entérologie Takeda est un leader mondial dans le domaine de la gastro-entérologie. Fort d'une expertise de plus de 25 ans, l'implication du groupe en faveur de l'innovation est en constante évolution et son impact est durable. ENTYVIO® (védolizumab) démontre la capacité globale de Takeda et son expansion sur le marché des soins de santé dans le domaine de la gastro-entérologie et de la biologie. Conçu et développé pour cibler précisément le tractus gastro-intestinal (GI), ENTYVIO a été lancé en 2014 pour traiter les adultes atteints de colite ulcéreuse modérée à sévère et de la maladie de Crohn. TAKECAB® (vonoprazan fumarate) est l'inhibiteur potassique compétitif de Takeda et a été lancé au Japon en 2015. Takeda commercialise également l'agent de motilité AMITIZA® (lubiprostone) initialement lancé en 2006 pour traiter la constipation idiopathique chronique, qui a ensuite reçu l'approbation pour traiter le syndrome du côlon irritable avec constipation et la constipation due aux opioïdes. Avant ces changements notables, Takeda a eu un rôle de pionnier dans les avancées gastro-entérologiques associées aux inhibiteurs de la pompe à protons au début des années 1990 avec le lansoprazole. Grâce à un développement spécialisé et stratégique en interne, à ses partenariats externes, contrats de licences et acquisitions, Takeda dispose actuellement de nombreux actifs prometteurs pour le domaine GI en stade précoce de développement et reste résolu à fournir des options thérapeutiques innovantes aux patients atteints de maladies de l'appareil digestif et du foie. À propos de Takeda Pharmaceutical Company Takeda Pharmaceutical Company Limited est une entreprise pharmaceutique globale centrée sur la R&D de médicaments innovants pour améliorer la santé des patients, en transposant la science pour générer des médicaments qui transforment les vies. Takeda concentre ses efforts de recherche en oncologie, gastro-entérologie et sur les maladies du système nerveux central. Il existe également des programmes spécifiques de développement dans les maladies cardio-vasculaires spécialisées ainsi que pour les candidats aux vaccins à des stades avancés. Takeda mène ses activités de R&D en interne et à travers des partenariats pour être à la pointe de l'innovation. Les nouveaux médicaments innovants de Takeda, en particulier en oncologie et en gastro-entérologie, ainsi que sa présence sur les marchés émergents, contribuent à la croissance de Takeda. Plus de 30 000 collaborateurs Takeda sont engagés à améliorer la qualité de vie des patients, en collaboration avec nos partenaires de santé dans plus de 70 pays. Pour plus d'informations, consultez le site http://www.takeda.com/news. À propos de TiGenix TiGenix NV (Euronext Bruxelles et Nasdaq : TIG) est une société biopharmaceutique de pointe centrée sur le développement et la commercialisation de nouvelles thérapies issues de ses plateformes exclusives d'expansion de cellules souches allogéniques, ou provenant de donneurs. Deux produits issus de la plateforme technologique de cellules souches dérivées de tissus adipeux sont en cours de développement clinique : Le Cx601 en phase III pour le traitement de fistules périanales complexes chez les patients atteints de la maladie de Crohn ; le Cx611 qui a complété un essai de phase I pour le traitement du sepsis et un essai de phase I/II pour le traitement de la polyarthrite rhumatoïde. Le 31 juillet 2015, TiGenix a fait l'acquisition de Coretherapix, dont le produit cellulaire phare, AlloCSC-01, fait actuellement l'objet d'un essai clinique de phase II pour le traitement de l'infarctus aigu du myocarde (IAM). En outre, le second produit candidat issu de la plateforme de cellules souches cardiaques acquise de Coretherapix, AlloCSC-02, est actuellement en cours de développement dans une indication chronique. Le 4 juillet 2016, TiGenix a conclu une convention de licence avec Takeda, une société leader en gastro-entérologie, selon laquelle Takeda a acquis le droit exclusif de commercialiser le Cx601 pour le traitement des fistules périanales complexes en dehors des États-Unis. Le siège social de TiGenix est basé à Louvain (Belgique) et la société a également des activités à Madrid (Espagne). Pour plus d'informations, veuillez consulter le site http://www.tigenix.com. À propos du Cx601 Le Cx601 est une suspension de cellules souches allogéniques expansées dérivées de tissus adipeux (eASC) injectée localement. Le Cx601 est un médicament expérimental développé pour le traitement des fistules périanales complexes chez les patients atteints de la maladie de Crohn qui 'ont répondu de manière insuffisante à au moins une thérapie conventionnelle ou biologique incluant des antibiotiques, des immunosuppresseurs ou des agents anti-facteur de nécrose tumorale (TNF). La maladie de Crohn est une maladie inflammatoire chronique de l'intestin et les patients peuvent souffrir de fistules périanales complexes pour lesquelles il n'existe actuellement aucun traitement efficace. En 2009, la Commission européenne a octroyé la désignation orpheline au Cx601 pour le traitement des fistules anales, reconnaissant la nature invalidante de la maladie et l'absence d'options de traitement. Le Cx601 a atteint l'objectif principal de l'étude de Phase III ADMIRE-CD chez les patients atteints de la maladie de Crohn souffrant de fistules périanales complexes, un essai randomisé en double-aveugle, contrôlé par placebo, en Europe et en Israël et conçu pour satisfaire aux exigences fixées par l'Agence européenne du médicament. Le « Réseau de Madrid » a émis un prêt bonifié pour aider à financer cette étude de Phase III, financée par le Secrétariat d'état pour la recherche, le développement et l'innovation (Ministère de l'économie et de la compétitivité) dans le cadre du plan INNTEGRA. Le critère d'évaluation principal de l'étude était la rémission combinée, définie comme une évaluation clinique à la 24e semaine de la cicatrisation de toutes les lésions extérieures ouvertes traitées à la base par drainage malgré une légère compression digitale, et l'absence de collections > 2cm, confirmée par IRM. Dans la population IDT (n = 212), le Cx601 a atteint une supériorité statistiquement significative (p = 0,024) sur le critère principal d'évaluation avec 50 % de rémission combinée à la 24e semaine, comparée à 34 % dans le groupe placebo. Les résultats d'efficacité étaient solides et cohérents dans l'ensemble des populations statistiques. Les événements indésirables liés au traitement (graves et non-graves) et les arrêts en raison d'événement indésirables étaient équivalents dans le groupe du Cx601 et le groupe placebo. Les résultats de la 24e semaine ont été publiés par The Lancet, un des revues médicales les plus appréciées et connues dans le monde. L'étude de Phase III a réalisé une analyse de suivi après 52 semaines, confirmant ainsi son efficacité et sa sécurité durables. Les grandes lignes des résultats de suivi ont démontré qu'au sein de la population IDT, le Cx601 a atteint une supériorité statistique (p = 0.012) avec 54 % de rémissions combinées à la 52e semaine, contre 37 % dans le groupe placebo. Les données de suivi de la 52e semaine montrent également un taux plus élevé de cicatrisation prolongée chez les patients traités par le Cx601 et en rémission combinée à la 24e semaine (75,0 %) par rapport aux patients du groupe placebo (55,9 %). Sur la base des résultats positifs de l'étude de Phase III de la 24e semaine, TiGenix a présenté une demande d'autorisation de mise sur le marché auprès de l'EMA début 2016. TiGenix s'apprête à développer le Cx601 aux États-Unis après avoir conclu une entente avec la FDA à travers une procédure d'évaluation spéciale de protocole (Special Protocol Assessment, SPA) en 2015. Le 4 juillet 2016 TiGenix a conclu un accord de licence avec Takeda, un chef de file de l'industrie pharmaceutique en gastroentérologie, selon lequel Takeda a acquis un droit exclusif de commercialiser le Cx601 pour les fistules périanales complexes chez les patients atteints de la maladie de Crohn en dehors des États-Unis. [1] Panés, J, García-Olmo, D, Van Assche, G, et al. Long-term efficacy and safety of Cx601, allogeneic expanded adipose-derived mesenchymal stem cells, for complex perianal fistulas in Crohn's Disease: 52-week results of a phase III randomized controlled trial. ECCO 2017; Barcelona: Abstract OP009. 2 Clinicaltrials.gov. Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease (ADMIRE-CD). https://clinicaltrials.gov/ct2/show/NCT01541579?term=cx601&rank=2. [Accessed February 9, 2017] 3 Burisch, J, Jess, T, Martinato, M, Lakatos, P, on behalf of ECCO - EpiCom. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis 2013; 7: 322 - 337 4 Swissmedic. About us - Collaboration - National collaboration - Patients and Users. Available at https://www.swissmedic.ch/ueber/01398/01400/03296/index.html?lang=en. [Accessed February 9, 2017]


De ADMIRE-CD-studie is een gerandomiseerde, dubbelblinde, placebogecontroleerde fase 3-studie, ontworpen voor het onderzoeken van de doeltreffendheid en veiligheid van het kandidaatgeneesmiddel Cx601 voor de behandeling van complexe perianale fistels bij patiënten met de ziekte van Crohn.[2] Patiënten werden gerandomiseerd naar één enkele toediening van Cx601-cellen of een placebo (controle), beide toegediend bovenop de zorgstandaard. Een significant groter percentage van de patiënten in de Cx601-groep ten opzichte van de controlegroep bereikte een klinische en radiologische gecombineerde remissie[*] (56,3% en 38,6%; p=0,010), en klinische remissie (59,2% en 41,6%; p=0,013) in week 52 in de gewijzigde intentie-tot-behandelenpopulatie (modified intention-to-treat population, mITT).1 Van deze mITT-patiënten die een gecombineerde remissie vertoonden in week 24, rapporteerde een groter aantal in de Cx601-groep geen herval in week 52 ten opzichte van de controlegroep (75,0% en 55,9%).1 De aantallen en soorten bijwerkingen die verband hielden met de behandeling (niet-ernstig en ernstig) en stopzettingen omwille van bijwerkingen bleken gelijkaardig te zijn in beide groepen (Cx601: 20,4%; controle: 26,5%).1 De ziekte van Crohn is een chronische ontstekingsaandoening van het maagdarmkanaal, waaraan vermoedelijk tot 1,6 miljoen mensen in Europa lijden.[3] Complexe perianale fistels zijn een complicatie voor mensen die leven met de ziekte van Crohn en er zijn beperkte behandelingsopties. De Europese Commissie erkende de gezondheidsondermijnende aard van de ziekte en het gebrek aan behandelingsopties en verleende Cx601 in 2009 erkenning als weesgeneesmiddel voor de behandeling van perianale fistels. In maart 2016 kondigde TiGenix aan dat het bij het Europees Geneesmiddelenbureau (European Medicines Agency, EMA) een aanvraag indiende voor een vergunning voor het in de handel brengen (Marketing Authorization Application, MAA) van Cx601, en men verwacht in 2017 een beslissing door het EMA. Bovendien werd in september 2016 de status van weesgeneesmiddel bekomen van het Zwitserse Geneesmiddelenagentschap (Swissmedic) voor Cx601 voor de zeldzame ziekte van complexe perianale fistels bij de ziekte van Crohn.[4] "Deze gegevens benadrukken dat de doeltreffendheid en veiligheid van één enkele toediening van Cx601 bleef aanhouden gedurende één jaar opvolging," zei Dr. Marie Paule Richard, Chief Medical Officer bij TiGenix. "Het is ook belangrijk te vermelden dat de definitie van gecombineerde remissie, die werd gebruikt in het ADMIRE-CD-onderzoek, met zowel klinische als radiologische beoordelingen met MRI, strikter is dan de criteria die gewoonlijk werden gebruikt in eerdere gerandomiseerde, grote klinische studies van perianale fistels bij de ziekte van Crohn , enkel gebaseerd op klinische beoordeling." TiGenix varwacht in 2017 een wereldwijde fase 3 pivotale studie te starten voor de Amerikaanse registratie van Cx601 voor de behandeling van complexe perianale fistels. In de VS is TiGenix van plan om een aanvraag in te dienen voor een versnelde toewijzing (fast track designation) vanwege de Amerikaanse Food and Drug Administration (FDA), wat het ontwikkelings- en evalutieproces in de VS zou vergemakkelijken en versnellen. Het engagement van Takeda tegenover gastro-enterologie Takeda is een wereldleider op het vlak van gastro-enterologie. Met een expertise van meer dan 25 jaar blijft de toewijding van het bedrijf t.o.v. innovatie verder evolueren en een blijvende impact hebben. ENTYVIO® (vedolizumab) demonstreert de globale mogelijkheden en de expansie in de gespecialiseerde zorgmarkt voor gastro-enterologie en biologische geneesmiddelen van Takeda. ENTYVIO, dat specifiek ontworpen en ontwikkeld werd voor het maag-darmkanaal, werd geïntroduceerd in 2014 voor de behandeling van volwassenen met matige tot ernstige colitis ulcerosa en de ziekte van Crohn. TAKECAB® (vonoprazan fumaraat) is de kalium-concurrerende zuurremmer van Takeda en werd geïntroduceerd in 2015 in Japan. Takeda commercialiseert ook het motiliteitsmiddel AMITIZA® (lubiprostone), dat oorspronkelijk geïntroduceerd werd in 2006 voor de behandeling van chronische idiopathische constipatie en daarna goedkeuring verkreeg voor het behandelen van het prikkelbaredarmsyndroom met constipatie en opioïd-geïnduceerde obstipatie. Voorafgaand aan deze opmerkelijke introducties, realiseerde Takeda gastro-enterologische doorbraken inzake protonpompremmers vanaf de jaren 1990 met lansoprazole. Dankzij gespecialiseerde en strategische in-house ontwikkeling, externe partnerships, in-licensing en acquisities heeft Takeda momenteel een aantal veelbelovende GI-middelen in een vroeg stadium in ontwikkeling en blijft het zich inzetten om innovatieve, therapeutische opties te leveren voor patiënten met gastro-intestinale en leveraandoeningen. Over Takeda Pharmaceutical Company Takeda Pharmaceutical Company Limited is een internationaal, R&D-gericht farmaceutisch bedrijf dat ernaar streeft om patiënten een betere gezondheid en een mooiere toekomst te bieden door wetenschap te vertalen in levensveranderende geneesmiddelen. Takeda focust haar onderzoeksinspanningen op de therapeutische gebieden oncologie, gastro-enterologie en het centraal zenuwstelsel. Het heeft ook specifieke ontwikkelingsprogramma's voor cardiovasculaire aandoeningen evenals kandidaat-vaccins in vergevorderd stadium. Takeda voert zowel intern als met partners R&D uit om toonaangevend te blijven op het vlak van innovatie. Nieuwe innovatieve producten, vooral met betrekking tot oncologie en gastro-enterologie, evenals de aanwezigheid op groeimarkten, voeden de groei van Takeda. Meer dan 30.000 werknemers van Takeda zetten zich in om de levenskwaliteit van patiënten te verhogen en zijn actief met onze partners in de gezondheidszorg in meer dan 70 landen. Voor meer informatie, ga naar http://www.takeda.com/news. Over TiGenix TiGenix NV (Euronext Brussel en Nasdaq: TIG) is een geavanceerd biofarmaceutisch bedrijf dat zich toespitst op de ontwikkeling en de commercialisering van innovatieve therapieën op basis van haar eigendomsrechtelijk beschermde platformen van allogene, of van donors afkomstige, geëxpandeerde stamcellen. Twee producten van het uit vetweefsel verkregen stamceltechnologieplatform zijn momenteel in klinische ontwikkeling: Cx601 in fase III voor de behandeling van complexe perianale fistels bij patiënten met de ziekte van Crohn; Cx611 dat een sepsisprovocatieonderzoek en een fase I-/II-onderzoek bij reumatoïde artritis heeft voltooid. Op 31 juli 2015 ging de overname van Coretherapix door TiGenix van kracht. Het voornaamste cellulaire product van Coretherapix, AlloCSC-01, is momenteel in een fase II klinisch onderzoek naar acuut myocardinfarct (AMI). Daarnaast wordt de tweede productkandidaat uit het op hartstamcellen gebaseerde platform dat via Coretherapix werd overgenomen, AlloCSC-02, ontwikkeld voor een chronische indicatie. Op 4 juli 2016 is TiGenix een licentieovereenkomst aangegaan met Takeda, een groot farmaceutisch bedrijf dat actief is in gastro-enterologie, waardoor Takeda de exclusieve rechten heeft verworven om Cx601 buiten de Verenigde Staten op de markt te brengen voor complexe perianale fistels. TiGenix heeft haar hoofdzetel in Leuven en heeft vestigingen in Madrid (Spanje). Over Cx601 Cx601 is een suspensie van allogene geëxpandeerde, uit vetweefsel verkregen stamcellen (expanded adipose stem cells, eASC) die lokaal wordt geïnjecteerd. Cx601 is een experimenteel middel dat wordt ontwikkeld voor de behandeling van complexe perianale fistels bij patiënten met de ziekte van Crohn die onvoldoende respons vertonen op minstens één conventionele of biologische behandeling waaronder antibiotica, immunosuppressiva of anti-TNF-behandeling. De ziekte van Crohn is een chronische ontstekingsziekte van de darmen en patiënten kunnen lijden aan complexe perianale fistels waarvoor momenteel geen effectieve behandeling bestaat. In 2009 verleende de Europese Commissie erkenning aan Cx601 als weesgeneesmiddel voor de behandeling van anale fistels. Het erkende daarmee de gezondheidsondermijnende aard van de ziekte en het gebrek aan behandelingsopties. Cx601 heeft het primaire eindpunt gehaald in de fase III ADMIRE-CDstudie bij patiënten met de ziekte van Crohn met complexe perianale fistels, een gerandomiseerde, dubbelblinde, placebogecontroleerde studie in Europa en Israël dat is opgezet om te voldoen aan de eisen die door het EMA zijn gesteld. 'Madrid Network' bood een zachte lening aan om te helpen deze fase III studie te financieren, dat werd gesponsord door de Staatssecretaris voor Onderzoek, Ontwikkeling en Innovatie (Ministerie van Economie en Concurrentievermogen) binnen het kader van het INNTEGRA-plan. Het primair eindpunt van de studie was gecombineerde remissie, die gedefinieerd was als de klinische beoordeling na 24 weken van het afsluiten van alle behandelde externe openingen die bij de uitgangswaarde drainage vertoonden ondanks voorzichtige compressie met een vinger, en geen collecties van > 2 cm, bevestigd door MRI. In ITT-populatie (n=212) bereikte Cx601 statistisch significante superioriteit (p=0,024) voor het primair eindpunt met 50% gecombineerde remissie na 24 weken vergeleken met 34% in de placebogroep. De doeltreffendheidsresultaten waren robuust en consistent in alle statistische populaties. Tijdens de behandeling optredende bijwerkingen (niet ernstige en ernstige) en stopzettingen vanwege bijwerkingen waren vergelijkbaar tussen de Cx601- en placebogroepen. De resultaten na 24 weken werden gepubliceerd in The Lancet, een van de meest gerenommeerde en bekendste medische tijdschriften ter wereld. De fase III studie heeft een opvolgingsanalyse bij 52 weken na de behandeling afgerond, waarbij het aangehouden doeltreffendheids- en veiligheidsprofiel werd bevestigd. Optimale follow-upgegevens toonden aan dat in de ITT-populatie Cx601 belangrijke statistische superioriteit bereikte (p=0,012) met 54% in gecombineerde remissie in week 52 in vergelijking met 37% in de placebogroep. De gegevens na 52 weken toonden ook een hoger aantal aangehouden sluitingen bij patiënten behandeld met Cx601 en in gecombineerde remissie in week 24 (75,0%), in vergelijking met patiënten in de placebogroep (55,9%). Op basis van de positieve fase III studieresultaten na 24 weken heeft TiGenix in het begin van 2016 een vergunningaanvraag (Marketing Authorisation Application) bij het EMA ingediend. TiGenix bereidt zich voor om Cx601 te ontwikkelen in de V.S. na een overeenkomst te hebben bereikt met de FDA (Food and Drug Administration [Amerikaanse inspectie voor voedings- en geneesmiddelen]) door een Special Protocol Assessment (SPA) in 2015. Op 4 juli 2016 heeft TiGenix een licentieovereenkomst ondertekend met Takeda, een groot farmaceutisch bedrijf dat actief is in gastro-enterologie, waardoor Takeda de exclusieve rechten heeft verworven om Cx601 buiten de V.S. op de markt te brengen voor complexe perianale fistels bij patiënten met de ziekte van Crohn. [1] Panés, J, García-Olmo, D, Van Assche, G, et al. Long-term efficacy and safety of Cx601, allogeneic expanded adipose-derived mesenchymal stem cells, for complex perianal fistulas in Crohn's Disease: 52-week results of a phase III randomized controlled trial. ECCO 2017; Barcelona: Abstract OP009. [2] Clinicaltrials.gov. Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease (ADMIRE-CD). https://clinicaltrials.gov/ct2/show/NCT01541579?term=cx601&rank=2. [Accessed February 9, 2017] [3] Burisch, J, Jess, T, Martinato, M, Lakatos, P, on behalf of ECCO - EpiCom. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis 2013; 7: 322 - 337 [4] Swissmedic. About us - Collaboration - National collaboration - Patients and Users. Available at https://www.swissmedic.ch/ueber/01398/01400/03296/index.html?lang=en. [Accessed February 9, 2017]


News Article | February 24, 2017
Site: www.accesswire.com

Liberty Biopharma Inc. (TSX-V: LTY) ("Liberty Biopharma" or "Company"). A study from the Perelman School of Medicine at the University of Pennsylvania has found that adult stem cells collected from human fat are distinctly more stable than other stem cells, such as fibroblasts from the skin, and have the potential for use in new therapies for the prevention and treatment of aging-related diseases. The discovery was made while the researchers were developing a new model to study chronological aging of these cells. The findings were published this month in the journal Stem Cells. The researchers found that stem cells collected directly from human fat - called adipose-derived stem cells (ASCs) - can make more proteins than originally thought. This gives ASCs the ability to replicate and maintain their stability, a finding that held true in cells collected from patients 24 - 64 years old. "The findings of this study are encouraging for the ASC therapies that are being developed by Liberty Biopharma," stated Dr. Richard Cook, MD, MSc, FRCSC, Chief Medical Officer of Liberty Biopharma. "The University of Pennsylvania researchers' findings suggest that ASCs may be particularly useful for anti-aging therapies. The study also demonstrated that ASCs are very robust in patients as old as 64 years of age. If the findings from this study are correct, the Liberty Biopharma System for isolating fresh ASCs may be able to support therapeutic options for older patients, whose need for stem-cell therapies is often greater." Learn more at the following web pages: https://www.pennmedicine.org/news/news-releases/2017/february/stem-cells-collected-from-fat-may-have-use-in-anti-aging-treatments DOI: 10.1002/stem.2592 Liberty Biopharma is a clinical stage biopharmaceutical company developing and commercializing regenerative stem cell technologies and therapeutic solutions for independence and quality of life. Our focus is on significant areas of clinical need, such as wound management, cardiovascular diseases, and autoimmune diseases. Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the Policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words "could," "intend," "expect," "believe," "will," "projected," "likely," "estimated," and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on current belief or assumptions as to the outcome and timing of such future events. Actual future results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that Liberty Biopharma may not successfully transition to a clinical stage company and successfully execute its development and commercialization activities. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to Liberty Biopharma. Readers are cautioned that the above list of risk factors is not exhaustive. The forward-looking information contained in this press release is made as of the date hereof and Liberty Biopharma is not obligated to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties, and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein. For further information, please contact:


News Article | February 24, 2017
Site: marketersmedia.com

RICHMOND, BC / ACCESSWIRE / February 24, 2017 / Liberty Biopharma Inc. (TSX-V: LTY) ("Liberty Biopharma" or "Company"). A study from the Perelman School of Medicine at the University of Pennsylvania has found that adult stem cells collected from human fat are distinctly more stable than other stem cells, such as fibroblasts from the skin, and have the potential for use in new therapies for the prevention and treatment of aging-related diseases. The discovery was made while the researchers were developing a new model to study chronological aging of these cells. The findings were published this month in the journal Stem Cells. The researchers found that stem cells collected directly from human fat - called adipose-derived stem cells (ASCs) - can make more proteins than originally thought. This gives ASCs the ability to replicate and maintain their stability, a finding that held true in cells collected from patients 24 - 64 years old. "The findings of this study are encouraging for the ASC therapies that are being developed by Liberty Biopharma," stated Dr. Richard Cook, MD, MSc, FRCSC, Chief Medical Officer of Liberty Biopharma. "The University of Pennsylvania researchers' findings suggest that ASCs may be particularly useful for anti-aging therapies. The study also demonstrated that ASCs are very robust in patients as old as 64 years of age. If the findings from this study are correct, the Liberty Biopharma System for isolating fresh ASCs may be able to support therapeutic options for older patients, whose need for stem-cell therapies is often greater." Learn more at the following web pages: https://www.pennmedicine.org/news/news-releases/2017/february/stem-cells-collected-from-fat-may-have-use-in-anti-aging-treatments DOI: 10.1002/stem.2592 Liberty Biopharma is a clinical stage biopharmaceutical company developing and commercializing regenerative stem cell technologies and therapeutic solutions for independence and quality of life. Our focus is on significant areas of clinical need, such as wound management, cardiovascular diseases, and autoimmune diseases. Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the Policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words "could," "intend," "expect," "believe," "will," "projected," "likely," "estimated," and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on current belief or assumptions as to the outcome and timing of such future events. Actual future results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that Liberty Biopharma may not successfully transition to a clinical stage company and successfully execute its development and commercialization activities. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to Liberty Biopharma. Readers are cautioned that the above list of risk factors is not exhaustive. The forward-looking information contained in this press release is made as of the date hereof and Liberty Biopharma is not obligated to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties, and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein. For further information, please contact: RICHMOND, BC / ACCESSWIRE / February 24, 2017 / Liberty Biopharma Inc. (TSX-V: LTY) ("Liberty Biopharma" or "Company"). A study from the Perelman School of Medicine at the University of Pennsylvania has found that adult stem cells collected from human fat are distinctly more stable than other stem cells, such as fibroblasts from the skin, and have the potential for use in new therapies for the prevention and treatment of aging-related diseases. The discovery was made while the researchers were developing a new model to study chronological aging of these cells. The findings were published this month in the journal Stem Cells. The researchers found that stem cells collected directly from human fat - called adipose-derived stem cells (ASCs) - can make more proteins than originally thought. This gives ASCs the ability to replicate and maintain their stability, a finding that held true in cells collected from patients 24 - 64 years old. "The findings of this study are encouraging for the ASC therapies that are being developed by Liberty Biopharma," stated Dr. Richard Cook, MD, MSc, FRCSC, Chief Medical Officer of Liberty Biopharma. "The University of Pennsylvania researchers' findings suggest that ASCs may be particularly useful for anti-aging therapies. The study also demonstrated that ASCs are very robust in patients as old as 64 years of age. If the findings from this study are correct, the Liberty Biopharma System for isolating fresh ASCs may be able to support therapeutic options for older patients, whose need for stem-cell therapies is often greater." Learn more at the following web pages: https://www.pennmedicine.org/news/news-releases/2017/february/stem-cells-collected-from-fat-may-have-use-in-anti-aging-treatments DOI: 10.1002/stem.2592 Liberty Biopharma is a clinical stage biopharmaceutical company developing and commercializing regenerative stem cell technologies and therapeutic solutions for independence and quality of life. Our focus is on significant areas of clinical need, such as wound management, cardiovascular diseases, and autoimmune diseases. Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the Policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words "could," "intend," "expect," "believe," "will," "projected," "likely," "estimated," and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on current belief or assumptions as to the outcome and timing of such future events. Actual future results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that Liberty Biopharma may not successfully transition to a clinical stage company and successfully execute its development and commercialization activities. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to Liberty Biopharma. Readers are cautioned that the above list of risk factors is not exhaustive. The forward-looking information contained in this press release is made as of the date hereof and Liberty Biopharma is not obligated to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties, and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein. For further information, please contact:


News Article | February 15, 2017
Site: www.eurekalert.org

Methicillin-resistant Staphylococcus aureus (MRSA) infections are caused by a type of staph bacteria that has become resistant to the antibiotics used to treat ordinary staph infections. The rise of MRSA infections is limiting the treatment options for physicians and surgeons. Now, an international team of researchers, led by Elizabeth Loboa, dean of the University of Missouri College of Engineering, has used silver ion-coated scaffolds, or biomaterials that are created to hold stem cells, which slow the spread of or kill MRSA while regenerating new bone. Scientists feel that the biodegradable and biocompatible scaffolds could be the first step in the fight against MRSA in patients. "Osteomyelitis is a debilitating bone infection that can result when MRSA invades bone tissue, including bone marrow or surrounding soft tissues," said Loboa, who also is a professor of bioengineering. "Increasingly, those in the healthcare profession are running out of choices when it comes to treating MRSA while regenerating tissue. Using previously reported scaffolds that were created in our lab, we set out to determine the efficacy of coating these structures with silver ions and whether they were useful in treating or preventing osteomyelitis." The scaffolds were created from a polymer called polylactic acid (PLA), which is an FDA approved material that eventually biodegrades in the body. Next, researchers applied a silver ion releasing coating to the scaffolds and "seeded" them with fat-derived adult stem cells that could be "triggered" to create bone cells. Researchers also seeded the scaffolds with MRSA so that they could observe whether silver ions could fight the bacteria. The scientists found that the silver ion-releasing scaffolds not only inhibited MRSA, but also supported bone tissue formation. "Silver is well known for its antimicrobial properties and is highly toxic to a wide range of microorganisms such as MRSA," Loboa said. "Silver ions work mechanically--they actually disrupt the cellular machinery of MRSA. Our research now has shown that bone tissues still can be formed even in the presence of MRSA. We've created the materials needed for bone tissue engineering that will allow patients to use their own fat cells to create patient-specific bone and surgically implant those cells and tissues while diminishing, or potentially eliminating, the risk of MRSA infection." The early-stage results of this research are promising. If additional studies are successful within the next few years, MU officials could request authority from the federal government to begin human device development. After this status has been granted, researchers may conduct human clinical trials with the hope of developing new treatments for osteomyelitis. Their findings, "Evaluation of Silver Ion-Releasing Scaffolds in a 3-D Coculture system of MRSA and Human Adipose-Derived Stem Cells for Their Potential Use in Treatment or Prevention of Osteomyelitis" recently was published in the journal Tissue Engineering, Part A. The research team included Mahsa Mohiti-Asli and Casey Molina of the Joint Department of Biomedical Engineering at the University of North Carolina and North Carolina State University, Diteepeng Thamonwan of Silpakorn University in Thailand, and Behnam Pourdeyhimi of NCSU. Editor's Note: For more on the story, please see: http://engineering.


News Article | February 16, 2017
Site: www.24-7pressrelease.com

HOUSTON, TX, February 16, 2017 /24-7PressRelease/ -- The tenth SpaceX cargo resupply launch to the International Space Station, targeted for launch Feb. 18, will deliver investigations that study human health, Earth science and weather patterns. Here are some highlights of the research headed to the orbiting laboratory: Crystal growth investigation could improve drug delivery, manufacturing Monoclonal antibodies are important for fighting off a wide range of human diseases, including cancers. These antibodies work with the natural immune system to bind to certain molecules to detect, purify and block their growth. The Microgravity Growth of Crystalline Monoclonal Antibodies for Pharmaceutical Applications (CASIS PCG 5) investigation will crystallize a human monoclonal antibody, developed by Merck Research Labs, that is currently undergoing clinical trials for the treatment of immunological disease. Preserving these antibodies in crystals allows researchers a glimpse into how the biological molecules are arranged, which can provide new information about how they work in the body. Thus far, Earth-grown crystalline suspensions of monoclonal antibodies have proven to be too low-quality to fully model. With the absence of gravity and convection aboard the station, larger crystals with more pure compositions and structures can grow. The results from this investigation have the potential to improve the way monoclonal antibody treatments are administered on Earth. Crystallizing the antibodies could enable methods for large-scale delivery through injections rather than intravenously, and improve methods for long-term storage. Understanding crystal growth in space could benefit researchers on Earth Without proteins, the human body would be unable to repair, regulate or protect itself. Crystallizing proteins provides better views of their structure, which helps scientists to better understand how they function. Often times, proteins crystallized in microgravity are of higher quality than those crystallized on Earth. LMM Biophysics 1 explores that phenomena by examining the movement of single protein molecules in microgravity. Once scientists understand how these proteins function, they can be used to design new drugs that interact with the protein in specific ways and fight disease. Identifying proteins that benefit from microgravity crystal growth could maximize research efficiency Much like LMM Biophysics 1, LMM Biophysics 3 aims to use crystallography to examine molecules that are too small to be seen under a microscope, in order to best predict what types of drugs will interact best with certain kinds of proteins. LMM Biophysics 3 will look specifically into which types of crystals thrive and benefit from growth in microgravity, where Earth's gravity won't interfere with their formation. Currently, the success rate is poor for crystals grown even in the best of laboratories. High quality, space-grown crystals could improve research for a wide range of diseases, as well as microgravity-related problems such as radiation damage, bone loss and muscle atrophy. X Prize-winning device seeks insight into how deadly bacteria become drug-resistant Microgravity accelerates the growth of bacteria, making the space station an ideal environment to conduct a proof-of-concept investigation on the Gene-RADAR device developed by Nanobiosym. This device is able to accurately detect, in real time and at the point of care, any disease that leaves a genetic fingerprint. Nanobiosym Predictive Pathogen Mutation Study (Nanobiosym Genes) will analyze two strains of bacterial mutations aboard the station, providing data that may be helpful in refining models of drug resistance and support the development of better medicines to counteract the resistant strains. Microgravity may hold key to scaling up stem cell cultivation for research, treatment Stem cells are used in a variety of medical therapies, including the treatment of stroke. Currently, scientists have no way of efficiently expanding the cells, a process that may be accelerated in a microgravity environment. During the Microgravity Expanded Stem Cells investigation, crew members will observe cell growth and morphological characteristics in microgravity and analyze gene expression profiles of cells grown on the station. This information will provide insight into how human cancers start and spread, which aids in the development of prevention and treatment plans. Results from this investigation could lead to the treatment of disease and injury in space, as well as provide a way to improve stem cell production for human therapy on Earth. Space-based lightning sensor could improve climate monitoring Lightning flashes somewhere on Earth about 45 times per second, according to space-borne lightning detection instruments. This investigation continues those observations using a similar sensor aboard the station. The Lightning Imaging Sensor (STP-H5 LIS) will measure the amount, rate and energy of lightning as it strikes around the world. Understanding the processes that cause lightning and the connections between lightning and subsequent severe weather events is a key to improving weather predictions and saving life and property. From the vantage of the station, the LIS instrument will sample lightning over a swider geographical area than any previous sensor. Raven seeks to save resources with versatile autonomous technologies Future robotic spacecraft will need advanced autopilot systems to help them safely navigate and rendezvous with other objects, as they will be operating thousands of miles from Earth. The Raven (STP-H5 Raven) studies a real-time spacecraft navigation system that provides the eyes and intelligence to see a target and steer toward it safely. Raven uses a complex system to image and track the many visiting vehicles that journey to the space station each year. Equipped with three separate sensors and high-performance, reprogrammable avionics that process imagery, Raven's algorithm converts the collected images into an accurate relative navigation solution between Raven and the other vehicle. Research from Raven can be applied toward unmanned vehicles both on Earth and in space, including potential use for systems in NASA's future human deep space exploration. Understanding Earth's atmosphere health could inform policy, protection The Stratospheric Aerosol and Gas Experiment (SAGE) program is one of NASA's longest running Earth-observing programs, providing long-term data to help scientists better understand and care for Earth's atmosphere. SAGE was first operated in 1979 following the Stratospheric Aerosol Measurement (SAM), on the Apollo-Soyuz mission. SAGE III will measure stratospheric ozone, aerosols, and other trace gases by locking onto the sun or moon and scanning a thin profile of the atmosphere. Understanding these measurements will allow national and international leaders to make informed policy decisions regarding the protection and preservation of Earth's ozone layer. Ozone in the atmosphere protects Earth's inhabitants, including humans, plants and animals, from harmful radiation from the sun, which can cause long-term problems such as cataracts, cancer and reduced crop yield. Studying tissue regeneration in space could improve injury treatment on Earth Only a few animals, such as tadpoles and salamanders, can regrow a lost limb, but the onset of this process exists in all vertebrates. Tissue Regeneration-Bone Defect (Rodent Research-4) a U.S. National Laboratory investigation sponsored by the Center for the Advancement of Science in Space (CASIS) and the U.S. Army Medical Research and Materiel Command, studies what prevents other vertebrates such as rodents and humans from re-growing lost bone and tissue, and how microgravity conditions impact the process. Results will provide a new understanding of the biological reasons behind a human's inability to grow a lost limb at the wound site, and could lead to new treatment options for the more than 30% of the patient population who do not respond to current options for chronic non-healing wounds. Crew members in orbit often experience reduced bone density and muscle mass, a potential consequence of microgravity-induced stress. Previous research indicates that reduced gravity can promote cell growth, making microgravity a potentially viable environment for tissue regeneration research. This investigation may be able to shed more light on why bone density decreases in microgravity and whether it may be possible to counteract it. These investigations will join many others recurring around the clock aboard the station, all benefitting future spaceflight and life on Earth. For more information about the science happening on station, visit International Space Station Research and Technology.


Monoclonal antibodies are important for fighting off a wide range of human diseases, including cancers. These antibodies work with the natural immune system to bind to certain molecules to detect, purify and block their growth. The Microgravity Growth of Crystalline Monoclonal Antibodies for Pharmaceutical Applications (CASIS PCG 5) investigation will crystallize a human monoclonal antibody, developed by Merck Research Labs, that is currently undergoing clinical trials for the treatment of immunological disease. Preserving these antibodies in crystals allows researchers a glimpse into how the biological molecules are arranged, which can provide new information about how they work in the body. Thus far, Earth-grown crystalline suspensions of monoclonal antibodies have proven to be too low-quality to fully model. With the absence of gravity and convection aboard the station, larger crystals with more pure compositions and structures can grow. The results from this investigation have the potential to improve the way monoclonal antibody treatments are administered on Earth. Crystallizing the antibodies could enable methods for large-scale delivery through injections rather than intravenously, and improve methods for long-term storage. Understanding crystal growth in space could benefit researchers on Earth Without proteins, the human body would be unable to repair, regulate or protect itself. Crystallizing proteins provides better views of their structure, which helps scientists to better understand how they function. Often times, proteins crystallized in microgravity are of higher quality than those crystallized on Earth. LMM Biophysics 1 explores that phenomena by examining the movement of single protein molecules in microgravity. Once scientists understand how these proteins function, they can be used to design new drugs that interact with the protein in specific ways and fight disease. Identifying proteins that benefit from microgravity crystal growth could maximize research efficiency Much like LMM Biophysics 1, LMM Biophysics 3 aims to use crystallography to examine molecules that are too small to be seen under a microscope, in order to best predict what types of drugs will interact best with certain kinds of proteins. LMM Biophysics 3 will look specifically into which types of crystals thrive and benefit from growth in microgravity, where Earth's gravity won't interfere with their formation. Currently, the success rate is poor for crystals grown even in the best of laboratories. High quality, space-grown crystals could improve research for a wide range of diseases, as well as microgravity-related problems such as radiation damage, bone loss and muscle atrophy. X Prize-winning device seeks insight into how deadly bacteria become drug-resistant Microgravity accelerates the growth of bacteria, making the space station an ideal environment to conduct a proof-of-concept investigation on the Gene-RADAR® device developed by Nanobiosym. This device is able to accurately detect, in real time and at the point of care, any disease that leaves a genetic fingerprint. Nanobiosym Predictive Pathogen Mutation Study (Nanobiosym Genes) will analyze two strains of bacterial mutations aboard the station, providing data that may be helpful in refining models of drug resistance and support the development of better medicines to counteract the resistant strains. Microgravity may hold key to scaling up stem cell cultivation for research, treatment Stem cells are used in a variety of medical therapies, including the treatment of stroke. Currently, scientists have no way of efficiently expanding the cells, a process that may be accelerated in a microgravity environment. During the Microgravity Expanded Stem Cells investigation, crew members will observe cell growth and morphological characteristics in microgravity and analyze gene expression profiles of cells grown on the station. This information will provide insight into how human cancers start and spread, which aids in the development of prevention and treatment plans. Results from this investigation could lead to the treatment of disease and injury in space, as well as provide a way to improve stem cell production for human therapy on Earth. Lightning flashes somewhere on Earth about 45 times per second, according to space-borne lightning detection instruments. This investigation continues those observations using a similar sensor aboard the station. The Lightning Imaging Sensor (STP-H5 LIS) will measure the amount, rate and energy of lightning as it strikes around the world. Understanding the processes that cause lightning and the connections between lightning and subsequent severe weather events is a key to improving weather predictions and saving life and property. From the vantage of the station, the LIS instrument will sample lightning over a swider geographical area than any previous sensor. Future robotic spacecraft will need advanced autopilot systems to help them safely navigate and rendezvous with other objects, as they will be operating thousands of miles from Earth. The Raven (STP-H5 Raven) studies a real-time spacecraft navigation system that provides the eyes and intelligence to see a target and steer toward it safely. Raven uses a complex system to image and track the many visiting vehicles that journey to the space station each year. Equipped with three separate sensors and high-performance, reprogrammable avionics that process imagery, Raven's algorithm converts the collected images into an accurate relative navigation solution between Raven and the other vehicle. Research from Raven can be applied toward unmanned vehicles both on Earth and in space, including potential use for systems in NASA's future human deep space exploration. The Stratospheric Aerosol and Gas Experiment (SAGE) program is one of NASA's longest running Earth-observing programs, providing long-term data to help scientists better understand and care for Earth's atmosphere. SAGE was first operated in 1979 following the Stratospheric Aerosol Measurement (SAM), on the Apollo-Soyuz mission. SAGE III will measure stratospheric ozone, aerosols, and other trace gases by locking onto the sun or moon and scanning a thin profile of the atmosphere. Understanding these measurements will allow national and international leaders to make informed policy decisions regarding the protection and preservation of Earth's ozone layer. Ozone in the atmosphere protects Earth's inhabitants, including humans, plants and animals, from harmful radiation from the sun, which can cause long-term problems such as cataracts, cancer and reduced crop yield. Studying tissue regeneration in space could improve injury treatment on Earth Only a few animals, such as tadpoles and salamanders, can regrow a lost limb, but the onset of this process exists in all vertebrates. Tissue Regeneration-Bone Defect (Rodent Research-4) a U.S. National Laboratory investigation sponsored by the Center for the Advancement of Science in Space (CASIS) and the U.S. Army Medical Research and Materiel Command, studies what prevents other vertebrates such as rodents and humans from re-growing lost bone and tissue, and how microgravity conditions impact the process. Results will provide a new understanding of the biological reasons behind a human's inability to grow a lost limb at the wound site, and could lead to new treatment options for the more than 30% of the patient population who do not respond to current options for chronic non-healing wounds. Crew members in orbit often experience reduced bone density and muscle mass, a potential consequence of microgravity-induced stress. Previous research indicates that reduced gravity can promote cell growth, making microgravity a potentially viable environment for tissue regeneration research. This investigation may be able to shed more light on why bone density decreases in microgravity and whether it may be possible to counteract it.


News Article | February 14, 2017
Site: globenewswire.com

TEL AVIV, Israel, Feb. 14, 2017 (GLOBE NEWSWIRE) -- Cellect Biotechnology Ltd. (Nasdaq:APOP) (TASE:APOP), a developer of stem cells isolation technology, announced today that it will file a petition with the Israeli court and Company shareholders to voluntarily delist Cellect from the Tel-Aviv Stock Exchange (TASE) in accordance with section 350 to the Israeli Company Law. Should the petition be approved, all shareholders will retain their pro-rated holdings, as trading will migrate to the NASDAQ Stock Exchange in the US. Company Chairman, Mr. Nuriel Chirich Kasbian commented, “Cellect is a leader in the Stem Cells therapeutic area with multi-billion dollar market potential for our transformative, patented technology and products. In order to maximize the value of the Company for all stakeholders, we believe being solely listed on NASDAQ in the US is most appropriate for Cellect at this time.  Based on our experience, it is clear to us that the US market better understands our vision and will demonstrate a stronger appreciation for the attractive long-term investment opportunity Cellect represents.” The key factors driving Cellect’s voluntary request for delisting from TASE include: Dr. Shai Yarkoni, Cellect CEO commented, “We are proud to be an Israeli company with innovative technology in a field that has the potential to transform medicine. It is our duty to ensure that our shares are traded on an exchange where our technology and business can be appropriately valued by investors.  To date, Cellect has successfully executed on its development and business goals, as planned, and we look forward to achieving further progress with our ongoing clinical trial and securing additional value-creating partnerships for the Company’s technology.  Cellect remains focused on creating long-term shareholder value, and we are confident that a sole listing on NASDAQ is an important step toward accomplishing this objective.” Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ:APOP) (NASDAQ:APOPW) (TASE:APOP). The Company has developed a breakthrough technology for the isolation of stem cells from any given tissue that aims to improve a variety of stem cells applications. The Company’s technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells for in quantity and quality that will allow stem cells related treatments and procedures. Cellect’s technology is applicable to a wide variety of stem cells related treatments in regenerative medicine and that current clinical trials are aimed at the cancer treatment of bone marrow transplantations. Forward Looking Statements           This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss the anticipated petition to be filed in the Israeli courts seeking to delist Cellect’s ordinary shares from the TASE, the long term attractive investment opportunity represented by Cellect, the expectation of increased liquidity as a result of a sole listing on Nasdaq and Cellect’s future progress with respect to its ongoing clinical trial and securing additional value-creating partnerships for its technology. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.'s final prospectus dated July 29, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. and in the Company’s period filings with the SEC and the Tel-Aviv Stock Exchange.

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