étude de phase – English Translation – Keybot Dictionary

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Des chercheurs au Japon ont mené une étude de phase II auprès des deux populations suivantes :
Researchers in Japan conducted a phase II study in two populations, as follows:
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Elle participe présentement à deux études cliniques canadiennes sur la thérapie cellulaire reposant sur les cellules progénitrices adultes : 1) un essai de phase I, en cours présentement, qui constitue le premier essai sur la thérapie cellulaire et génique au Canada et 2) une nouvelle étude de phase II.
Dr. Eliopoulos is also engaged in clinical research through her role as Laboratory Director of the JGH CPC clinical-grade cell handling facility, which is committed to fostering early-phase trials testing cell-based technologies. She is presently involved in two Canadian cell therapy clinical studies using adult progenitor cells: 1) an on-going Phase I trial, which is the first cell and gene therapy trial in Canada; and 2) a newly approved Phase II study. The JGH CPC is one of only two facilities in Canada presently preparing patient cells for cell and gene therapy clinical trials.
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En 2007, la Dre Metz a reçu du financement de la Fondation pour la recherche scientifique sur la SP dans le but de réaliser une étude de phase IIIportant sur l’innocuité et l’efficacité de la minocyclinechez des patients qui ont déjà présenté des symptômes précoces évocateurs de la SP, à savoir un syndrome clinique isolé (SCI).
A number of animal studies and human pilot trials have conferred beneficial properties of minocycline in MS. Further, a phase II, multi-centre, double-blind, placebo-controlled clinical trial led by Dr. Metz and team compared the efficacy of minocycline administered in combination with glatiramer acetate to glatiramer acetate and placebo in 44 participants with relapsing-remitting MS. Treatment with minocycline and glatiramer acetate reduced the number lesions on MRI, although it did not reach statistical significance.
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Aeterna Zentaris annonce les résultats de l’analyse intérimaire complétée par la Data Safety Monitoring Board pour l’étude de phase 3 avec perifosine sur le cancer colorectal avancé réfractaire
Aeterna Zentaris Announces Completion of Interim Analysis by Data Safety Monitoring Board for the Phase 3 Study of Perifosine for the Treatment of Refractory Advanced Colorectal Cancer
  www.wiesheu.de  
Valneva SE, société leader dans l’industrie des vaccins, a annoncé des résultats positifs de Phase II pour son candidat vaccin prophylactique contre l’infection au Clostridium difficile (C. difficile). Les principaux objectifs de l’étude de Phase II ont été atteints.
Valneva SE, a leading pure-play vaccine company, announced today, positive Phase II results for its prophylactic vaccine candidate against Clostridium difficile (C.difficile) infection (CDI). The key objectives of this Phase II trial have been met, the vaccine candidate generated strong immune responses against C. difficile toxins A and B, and the safety and tolerability profile was good.
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Cette étude sera prochainement suivie par une étude de phase III randomisée en double aveugle qui, si elle est concluante, permettra de faire une demande d’enregistrement auprès des autorités de santé européennes.
Neurochlore is currently developing a treatment, produced in France, which will be able to ameliorate ASD in children and adolescents. The company has already conducted a successful monocentric study (Lemonnier et al., Translational Psychiatry, 2012). More recently, in order to confirm the efficacy and tolerance of this new treatment, we have just completed a phase II clinical trial, approved by the EMA (European Medicines Agency), and held in 6 French centers (Brest, Limoges, Lyon, Marseille, Nice and Rouen; Lemonnier et al., Translational Psychiatry, 2017). This study will be soon followed by a double-blind randomized phase III study that, if successful, will allow to submit a registration application to the European health authorities. The treatment duration will be one year, and all patients will receive the active treatment at least for six months. For this trial, four hundred patients (children and adolescents) will be recruited in different European countries.
  encan.esse.ca  
Le développement de médicaments dérivés de médicaments existants et de NEC est plus avancé que celui des vaccins : 56% (38/68) des candidats vaccins/produits biologiques sont en cours d’étude de Phase I, tandis que 85% (29/34) des médicaments issus de médicaments existants et 63% (10/16) des NEC sont en cours d’étude de Phases II-III.
Most newly developed therapeutic products were repurposed versions of existing drugs. Of the 336 brand-new drugs (new chemical entities, or NCEs) approved for all diseases in 2000-2011, only four, or 1%, were for neglected diseases; three were for malaria, and one for diarrheal disease.None were for any of the 17 WHO-listed NTDs.
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Nous souhaitons mener cette étude de phase II pour découvrir, en collaboration avec la fondation néerlandaise HOVON (Haemato Oncology Foundation for Adults in The Netherlands), dans quelle mesure le médicament appelé selinexor (KPT-330) est bien toléré et efficace lorsqu’il est adjoint au traitement standard pour la leucémie myéloïde aiguë (maladie rare aiguë et maligne des organes hématopoïétiques), qui consiste en une chimiothérapie intensive.
In this phase II trial, and in collaboration with HOVON (the Haemato Oncology Foundation for Adults in The Netherlands), we investigate the tolerability and the effectiveness of the drug Selinexor (KPT-330) in combination with the standard therapy. The standard therapy for acute myeloid leukemia (rare, acute cancer of the blood-forming organs) is an intensive chemotherapy. Selinexor is a new drug that retains Tumor-suppressor proteins within the cell nucleus leading to an improved regulation of the tumor growth. This potentially leads to an better tumor control.
  3 Hits www.hepcinfo.ca  
La société pharmaceutique Bristol-Myers Squibb a suspendu une étude de phase II sur un traitement potentiel contre l'hépatite C appelé BMS-986094 à la suite d'au moins un cas d'insuffisance cardiaque survenue durant l'essai.
The pharmaceutical company Bristol-Myers Squibb is suspending a phase 2 study of a potential hepatitis C treatment, known as BMS-986094, after at least one participant in the trial experienced heart failure. “We are working in close collaboration with clinical trial investigators and health authorities to ensure the appropriate steps are being taken to protect patient safety,” said a spokeswoman for the company. (New York Times, August 2012, in English)
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Notre programme clinique principal est ALLOB ® , un produit de thérapie cellulaire allogénique « prêt-à-l’emploi » obtenu à partir de cellules souches de donneurs sains, qui est en étude de phase II dans le traitement des fractures avec retard de consolidation et dans la fusion vertébrale.
Our primary clinical focus is ALLOB ® , an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB ® , obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis and non-union fractures.
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Lors d’une étude de phase II, on a constaté que l’association de méthotrexate, de rituximab (Rituxan), de procarbazine (Natulan), de vincristine (Oncovin) et de cytarabine (Cytosar, Ara-C) suivie d’une radiothérapie à dose réduite à la tête est un traitement efficace du lymphome primitif du SNC récemment diagnostiqué (ASCO, Abstract 2006).
A phase II study found that the combination of methotrexate, rituximab (Rituxan), procarbazine (Natulan), vincristine (Oncovin) and cytarabine (Cytosar, Ara-C) followed by a reduced dose of radiation therapy to the head is an effective treatment for people with newly diagnosed primary CNS lymphoma (ASCO, Abstract 2006).
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L’étude de phase I/IIa a pour objectif premier d’évaluer la sécurité et la faisabilité des cellules CAR-T NKG2D ainsi que d’autres critères, dont l’efficacité clinique. Les données portant sur les 12 premiers patients traités en Phase I sont attendues pour mi-2016.
The Phase I/IIa trial is designed to assess the safety and feasibility of NKG2D CAR T-Cells, with secondary endpoints including clinical activity. Data readouts from the first 12 patients treated in the Phase I portion are expected in mid-2016. Once the recommended dose is determined, the IIa phase of the trial will commence, with 12 additional patients treated at the recommended dose.
  20 Hits www.bmscanada.ca  
BRISTOL-MYERS SQUIBB PRÉSENTE LES DONNÉES D'UNE ÉTUDE DE PHASE III DEMONTRANT QUE LE TRAITMENT EXPERIMENTAL DE COMBINAISON ORALE DACLATASVIR/ASUNAPRÉVIR PRODUIT DES TAUX DE RÉPONSE VIRALE SOUTENUE (RVS12) JUSQU'À 90 % CHEZ UN VASTE ÉVENTAIL DE PATIENTS ATTEINTS D'HÉPATITE C DE GÉNOTYPE 1B
BRISTOL-MYERS SQUIBB PRESENTS PHASE III DATA DEMONSTRATING THAT INVESTIGATIONAL ALL-ORAL DACLATASVIR AND ASUNAPREVIR THERAPY ACHIEVED SVR12 RATES OF UP TO 90% AMONG BROAD RANGE OF GENOTYPE 1B HEPATITIS C PATIENTS
  phallus.is  
Une deuxième étude de phase III montre que le carfilzomib (Kyprolis®) améliore considérablement la survie globale des patients atteints d’un myélome multiple récidivant
A Second Phase III Study Shows That Carfilzomib (Kyprolis®) Significantly Improves Overall Survival in Patients with Relapsed Multiple Myeloma
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Des chercheurs au Japon ont mené une étude de phase II auprès des deux populations suivantes :
Researchers in Japan conducted a phase II study in two populations, as follows:
  16 Hits www.2025ev.de  
Innate Pharma annonce le recrutement du premier patient dans l’étude de Phase I évaluant IPH5401 en combinaison avec durvalumab (Imfinzi®) dans différentes tumeurs solides
Innate pharma announces enrollment of first patient in the Phase I study of IPH5401 in combination with durvalumab (Imfinzi®) in solid tumors
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Critère d’évaluation principal de l’étude de Phase I (VLA15-101) atteint
Valneva Reports Positive Phase I Interim Results for Its Lyme Vaccine Candidate VLA15
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CTN 203 : Étude de phase I/II sur Remune® plus Amplivax™
CTN 203: Phase I/II study of Remune® plus Amplivax™
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Nicox : Initiation d’une étude de phase 2 pour le NCX 470 dans le glaucome à angle ouvert et l’hypertension oculaire
Nicox Initiates Phase 2 Study of NCX 470 in Open-Angle Glaucoma and Ocular Hypertension
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Vous pourriez être admissible pour participer à une étude de phase I ou agir à titre de témoin.
You may be eligible to participate in a phase 1 study or as a control.
  esa.int  
Le Comité des participants au programme Aurora a récemment autorisé le lancement d’une étude de phase A d’ExoMars qui examinera également la possibilité d’associer la mission française Netlander au projet européen.
As its name suggests, the ExoMars mission is expected to provide significant new insights into the surface environment of the Red Planet, with particular emphasis on exobiology, the search for signs of Martian life, past or present. The configuration of the ExoMars mission is still being defined. As currently envisaged, the ExoMars orbiter will release a descent module and solar-powered rover onto the planet’s pristine surface. Equipped with a drill and sampling system, this autonomous roving vehicle will spend many months exploring the hostile terrain and analysing soil from sites that might be hospitable to primitive Martian life forms. The Aurora Board of Participants recently authorised a phase A study of ExoMars that will also look into the possibility of combining the French Netlander mission with the European effort.
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Il se rend au cœur par le transporteur de la noradrénaline117. Les données préliminaires issues d'une étude de phase I illustrent que le LMI1195 peut produire des images de haute qualité, bien définies, du système nerveux autonome du coeur118.
18F-fluoro-L-thymidine (18F-FLT) is a novel PET tracer that accumulates in cells with high thymidine kinase-1 activity, reflecting areas of cell proliferation. Since 18F-FLT is absorbed well by cancer cells, it can determine if chemotherapy is working — often very early in the course of chemotherapy treatment. Numerous small studies have reported on 18F-FLT’s performance as a measure of tumour proliferation in squamous cell carcinoma,127 lung cancer,128 colorectal cancer,129 and brain cancer.130
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Les fonds levés permettront à la société d’avancer les études cliniques de ses molécules en portefeuille, en particulier de son produit phare, le lanifibranor, et ainsi mener les travaux préparatoires de l’étude de Phase III dans le traitement de la NASH, une pathologie sévère du foie en fort développement et qui touche déjà aux Etats-Unis plus de 30 millions de personnes et la sclérose systémique, une maladie orpheline avec un important besoin médical.
• Sofinnova Partners invested €10 M in the capital increase. • Funds will be used to advance the clinical programs of the company’s portfolio compounds. • A representative of Sofinnova Partners shall be designated at the Board of directors of Inventiva. Paris, France, April 19th. 2018 – Sofinnova Partners, a leading European venture capital firm specialized in Life Sciences, announced today is led Inventiva Pharma (IVA) €35,5 M capital increase through its newly created Sofinnova Crossover I Fund. Sofinnova Partners invested €10 M, becoming one of the company’s largest investors. Inventiva, listed on Euronext Paris (IVA), is a biopharmaceutical company specialized in the development of treatments for fibroticand orphan diseases, such as Non Alcoholic Steato Hepatitis (NASH), systemic scleroderma (SSc) and mucopolysaccharidosis (MPS). Inventiva has a strong technology platform built on its extensive knowledge of the mechanisms of fibrosis, a chemical library of over 240,000 molecules and cell models, including patient cells, helping accelerate the discovery of new mechanisms and therapeutic candidates for the treatment of fibrotic diseases, orphan diseases and cancers. Funds raised will allow Inventiva to advance its portfolio of compounds in the clinic, in particular its lead compound, lanifibranor, through preparatory studies towards a Phase III trial for the treatment of NASH, a growing liver disease that affects more than 30 million people in the United States, and of systemic sclerosis an orphan disease with high unmet medical needs. Funds will also allow Inventiva to advance its second program, odiparcil, a drug candidate for the treatment of multiple forms of mucopolysaccharidosis. Jacques Theurillat, Partner in the Sofinnova Crossover I Fund, commented: « Inventiva is exactly the type of company we are seeking to invest in with our Crossover fund: innovative technology addressing diseases of high unmet medical need with large market sizes, an experimented team backed by a prestigious international investor syndicate helping the company develop its global ambitions ». Press contact for Sofinnova Partners Anne Rein Tel: +33 6 03 35 92 05 e-mail: anne.rein@strategiesimage.com