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Banook Central Imaging Selected by Servier to Provide Innovative Image Analysis Services Based on a Combination of RECIST, IrRC and TGR Assessment



10/9/2013 9:41:47 AM

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Banook Central Imaging, Nancy, France – October 9, 2013 -- Banook Central Imaging (BanookCI), a global imaging core lab for drug and device clinical trials, announced today it has been selected by Servier to assess the potential anti-tumour activity of a novel monoclonal antibody based on RECIST 1.1 criteria and Immune-Related Response criteria (IrRC). Following on the successful research conducted by Gomez-Roca et al1 at Gustave Roussy Cancer Center, this multicenter, international Phase I study in patients with breast cancer will also incorporate the use of Tumor Growth Rates (TGR). TGR assessment will allow Servier to explore the growth rate before and after treatment allowing for a more granular look at the effectiveness of the drug in development than can be provided by RECIST 1.1 alone.

Pr. Jean-Charles Soria, head of the early drug development program at the Institut Gustave Roussy (IGR), Villejuif France, states, “In this new era of personalized medicine, it may be essential to redefine response to treatment and identify patients in whom a treatment has a beneficial impact on tumour growth. We are convinced that the collaboration between Servier, IGR and BanookCI creates a unique opportunity to bring forward a new generation of efficacy assessment criteria in drug development”.

Throughout this trial, BanookCI will leverage their comprehensive imaging core lab services, including specialized radiologic review and analysis of all images. Employing state-of-the art software, BanookCI supports and automates all the necessary tasks for rigorous follow-up of the radiologic exams, allowing readers to focus on accurate image interpretation and response analysis. Combining this sophisticated and robust imaging software with experienced imaging professionals allows BanookCI to incorporate innovative analyses such as TGR with RECIST and IrRC.

“We are delighted to go into this new collaboration with Servier.” comments Dr. Pascal Voiriot, Founder and Chief Executive Officer of BanookCI. “Our customers are increasingly attempting to include new methodologies such as TGR or IrRC in their clinical programs. We continuously look for innovative solutions aiming at a better and earlier evaluation of the response of patients to the new therapeutic approaches of cancer. BanookCI is setting the bar for the industry”.

For more information concerning this press release or BanookCI please contact Fabien Du Fraisse (Europe) at +33 (0)3 83 39 43 10 (fabien.dufraisse@banook-ms.com) or Craig Pennington (United States) at +1-314-299-4148 (craig.pennington@banook-ci.com) Additional information can also be found at www.banook-ci.com.

About Banook Central Imaging (www.banook-ci.com)

BanookCI is a global service organization providing medical image management for clinical research to academic centers as well as pharmaceutical, biotechnology and medical device industries. We help our clients secure an expeditious marketing approval by providing objective, reliable and rigorous image acquisition, analysis and processing services that exceed scientific standards of excellence and regulatory requirements. BanookCI has been implementing state-of-the-art technologies to handle large volumes of data in full compliance with a comprehensive set of operating procedures and all applicable regulatory guidelines. These services are supported by a multidisciplinary team including technicians, IT professionals, data managers, specialists in logistics, quality assurance and regulatory affairs, as well as medical experts. All staff members work collaboratively to develop innovative solutions and deliver data of the highest quality and integrity within the agreed timelines.

About Servier (www.servier.com)

Servier is a privately-run research based pharmaceutical company with a 2012 turnover of €3.9 billion. Servier reinvests 25% of its turnover in Research & Development in oncology, cardiovascular, metabolic, neurological, psychiatric and rheumatological diseases. Servier is established in 140 countries worldwide with over 20,000 employees.

About Institut Gustave Roussy (www.gustaveroussy.fr)

The Institut Gustave-Roussy (IGR) is the leading European Cancer Centre. It assembles on the same site 2,500 men and women whose missions are to treat patients suffering from cancer, conduct research and develop new therapies, and to pass on knowledge and know-how to the medical and scientific communities in France and worldwide. One hundred and twenty four statutory physicians are working in the 400-bed hospital, with an annual recruitment of over 11,000 new patients, 130,000 patients attending its clinics and 42,000 patients receiving treatment. Research is conducted by 400 research scientists, and over 5,000 hours of instruction are taught in its School of Oncology in collaboration with the University of Paris. The 3 missions of IGR ire founded on 3 principles that are the guiding force behind IGR’s actions daily: excellence, innovation and evaluation.

1- Gomez-Roca C et al. Eur J Cancer 2011; 47: 2512-6

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