The Giens 2015 Workshop Round Table entitled "What specifications for a centre or network of excellence in clinical research?" took a viewpoint distinct from earlier work and studies on changes in clinical research activities in France. The purpose of the present work was to identify, starting from concrete examples, the main strengths and advantages of clinical research activity in France related, in part, to the background environment and also to the specific characteristics of the investigation centres considered to be among the most high-performance units in activity. The criteria retained were grouped into a set of specifications that could be used to establish a "label of excellence" upon which the different teams and clinical research centres could model themselves. It was thus considered that belonging to a centre or structured network with at least a national configuration, when this is possible for the medial topic in question, constitutes a real advantage. Four benchmarks were identified: the scientific and clinical expertise of the head investigator, as well as the qualification and operational capacity of the centre’s team; definition and measurement of performance using clearly displayed indicators and evaluation procedures; the quality of the overall trial "process" and of each of its component steps; communication, because know-how and promotion go hand in hand, with the main objective of informing the professional and general public about the value of the research centre meeting the above-mentioned criteria, about its networks of competencies, and more generally, about the important assets of the background of clinical research in France. This sector of research is funded by the public authorities via calls for public grants, financial aids for structures supporting clinical research in the University Hospital Centres and other healthcare institutions allowing for a professionalization of the research occupations, and the national public health plans (cancer, rare disease, HIV).
Copyright © 2016. Published by Elsevier Masson SAS.

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Short intensive chemotherapy is the standard of care for adult patients with Burkitt’s leukaemia or lymphoma. Findings from single-arm studies suggest that addition of rituximab to these regimens could improve patient outcomes. Our objective was to test this possibility in a randomised trial.
In this randomised, controlled, open-label, phase 3 trial, we recruited patients older than 18 years with untreated HIV-negative Burkitt’s lymphoma (including Burkitt’s leukaemia) from 45 haematological centres in France. Exclusion criteria were contraindications to any drug included in the chemotherapy regimens, any serious comorbidity, poor renal (creatinine concentration >150 μmol/L) or hepatic (cirrhosis or previous hepatitis B or C) function, pregnancy, and any history of cancer except for non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma. Patients were stratified into two groups based on disease extension (absence [group B] or presence [group C] of bone marrow or central nervous system involvement). Patients were further stratified in group C according to age (<40 years, 40-60 years, and >60 years) and central nervous system involvement. Participants were randomly assigned in each group to either intravenous rituximab injections and chemotherapy (lymphome malin B [LMB]) or chemotherapy alone by the Groupe d’Etude des Lymphomes de l’Adulte datacentre. Randomisation was stratified by treatment group and centre using computer-assisted permuted-block randomisation (block size of four; allocation ratio 1:1). We gave rituximab (375 mg/m(2)) on day 1 and day 6 during the first two courses of chemotherapy (total of four infusions). The primary endpoint is 3 year event-free survival (EFS). We analysed all patients who had data available according to their originally assigned group. This trial is registered with ClinicalTrials.gov, number NCT00180882.
Between Oct 14, 2004, and Sept 7, 2010, we randomly allocated 260 patients to rituximab or no rituximab (group B 124 patients [64 no rituximab; 60 rituximab]; group C 136 patients [66 no rituximab; 70 rituximab]). With a median follow-up of 38 months (IQR 24-59), patients in the rituximab group achieved better 3 year EFS (75% [95% CI 66-82]) than did those in the no rituximab group (62% [53-70]; log-rank p stratified by treatment group=0·024). The hazard ratio estimated with a Cox model stratified by treatment group, assuming proportionality, was 0·59 for EFS (95% CI 0·38-0·94; p=0·025). Adverse events did not differ between the two treatment groups. The most common adverse events were infectious (grade 3-4 in 137 [17%] treatment cycles in the rituximab group vs 115 [15%] in the no rituximab group) and haematological (mean duration of grade 4 neutropenia of 3·31 days per cycle [95% CI 3·01-3·61] vs 3·38 days per cycle [3·05-3·70]) events.
Addition of rituximab to a short intensive chemotherapy programme improves EFS in adults with Burkitt’s leukaemia or lymphoma.
Gustave Roussy Cancer Campus, Roche, Chugai, Sanofi.
Copyright © 2016 Elsevier Ltd. All rights reserved.

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On April 16, 2016 Abpro, an integrated life science company at the forefront of synthetic biology, reported a partnership with Essex Bio, a China-based biopharmaceutical company (Press release, abpro therapeutics, APR 16, 2016, View Source [SID1234525612]). Abpro and Essex will co-develop multiple monoclonal antibodies in immuno-oncology and ophthalmology by leveraging Abpro’s DiversImmune platform. Abpro received a $3.5M equity investment from Essex Bio and an undisclosed amount from affiliates, as part of the agreement.

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"This partnership with Essex Bio adds further validation to our discovery platform and provides an opportunity to advance novel therapeutics with one of the largest ophthalmology companies in China, which is the second largest pharmaceutical market in the world," said Ian Chan, CEO of Abpro. "This agreement results in a strong partnership with R&D efforts and significant capabilities both in the United States and China."

"Abpro’s unique proprietary platform has proven to be successful against traditionally difficult targets for antibodies and offers significant potential for us to co-develop novel therapeutic treatments for immuno-oncology and ophthalmic diseases," said Patrick Ngiam, Founder and Chairman of Essex Bio. "We look forward to leveraging this platform to advance monoclonal assets into the clinic and onto commercialization."

According to the agreement, Abpro will receive an upfront equity investment from Essex Bio and affiliates. The companies will advance multiple assets through pre-clinical and clinical development and seek commercial authorizations. Essex Bio holds commercial rights to these assets in China, and Abpro retains commercialization rights in the U.S. and rest of world, excluding China, with cross-royalties from each region. Through its DiversImmune platform, Abpro generates antibodies with high sensitivity and specificity for advancing human health.

Abpro’s products and discovery services are used by leading academic labs and companies around the world for life science research purposes, such as therapeutics, diagnostics and research products. Abpro has formed multiple partnerships around novel biomolecules with leading biotechnology and international pharmaceutical companies including Amgen, Eli Lilly, Genzyme, MedImmune, Merck, Novartis, Pfizer, and others. In addition, Abpro has collaborated with several academic research centers, including Harvard University, Massachusetts Institute of Technology and Stanford University.

On April 16, 2016 Redx Pharma’s cancer subsidiary, Redx Oncology, reported that it has developed novel, differentiated, reversible small molecule inhibitors of Bruton’s tyrosine kinase (BTK) and will be presenting its poster to the scientific community next week at the AACR (Free AACR Whitepaper)’s 2016 annual gathering (Press release, Redx Pharma, APR 16, 2016, View Source [SID1234524743]). Redx’s lead compound has a favorable in vitro safety profile and drug-like properties, displaying an improved CYP profile to competitor compounds. In vivo PK demonstrated good oral bioavailability.

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This breakthrough is part of Redx’s work to develop best-in-class treatments for leukaemia, other blood cancers, and autoimmune diseases such as rheumatoid arthritis, lupus, and Sjögren’s Syndrome.

Dr Nicolas Guisot will be presenting the program on Wednesday 20 April between 7:30 and 11:00am in Section 19, Poster Board Number 20. If you would like to meet with our scientists or business development team please contact Dr Matilda Bingham, Executive Director of Redx Oncology.

The presentation abstract and author information is available here:
View Source

Bioorthogonal turn-on probes have been widely utilized in visualizing various biological processes. Most of the currently available bioorthogonal turn-on probes are blue or green emissive fluorophores with azide or tetrazine as functional groups. Herein, we present an alternative strategy of designing bioorthogonal turn-on probes based on red-emissive fluorogens with aggregation-induced emission characteristics (AIEgens). The probe is water soluble and non-fluorescent due to the dissipation of energy through free molecular motion of the AIEgen, but the fluorescence is immediately turned on upon click reaction with azide-functionalized glycans on cancer cell surface. The fluorescence turn-on is ascribed to the restriction of molecular motion of AIEgen, which populates the radiative decay channel. Moreover, the AIEgen can generate reactive oxygen species (ROS) upon visible light (λ=400-700 nm) irradiation, demonstrating its dual role as an imaging and phototherapeutic agent.
© 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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