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Banook Central Imaging (Banook CI), a global imaging core lab for drug and device clinical trials, announces today that it has been selected by Servier to assess the potential anti-tumor activity of a novel monoclonal antibody based on the RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) and Immune-Related Response criteria (IrRC). Following on from the successful research conducted by Gomez-Roca et al 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. This will allow for a more detailed look at the effectiveness of the drug in development than that provided by RECIST 1.1 alone.
“In this new era of personalized medicine, it may be essential to redefine the response to treatment and identify those patients in whom the treatment has a beneficial impact on tumor growth,” said Professor Jean-Charles Soria, head of the early drug development program at the Institut Gustave Roussy (IGR), in Villejuif (France). “We are convinced that the collaboration between Servier, IGR and Banook CI creates a unique opportunity to bring forward a new generation of efficacy assessment criteria in drug development.”
Throughout this trial Banook CI will leverage their comprehensive imaging core lab services, including a specialized radiologic review and analysis of all images. Employing state-of-the art software, Banook CI supports and automates all the necessary tasks for the rigorous follow-up of the radiologic exams. This allows readers to focus on accurate image interpretation and response analysis. Combining this sophisticated and robust imaging software with experienced imaging professionals allows Banook CI to incorporate innovative analyses such as TGR with RECIST and IrRC.
“We are delighted to start this new collaboration with Servier,” said Dr. Pascal Voiriot, founder and chief executive officer at Banook CI. “Our customers increasingly attempt to include new methodologies such as TGR or IrRC in their clinical programs. We are always looking for innovative solutions aimed at better and earlier evaluation of the response of patients to the new therapeutic approaches for cancer. Banook CI is setting the bar for the industry.”