The contract covers the implementation of an advanced imaging biomarker in solid tumors evaluation. Tumor volume, an exploratory imaging biomarker, will be implemented to assess preliminary antitumor efficacy of an oncology investigational drug in phase I.
MEDIAN Technologies (ALMDT), a leading medical imaging software solutions developer, and a service provider for image interpretation and management in oncology clinical trials, today announced that it has signed a €206K firm contract with one of its top 10 biopharmaceutical company client. The contract covers the implementation of an exploratory imaging biomarker, tumor volume, in a first-in-man phase I study on adult patients with advanced malignant solid tumors.
Within the framework of the contract, Progression Free Survival (PFS) will be measured on patients enrolled with RECIST 1.1[1]. This widely-used standard criterion for response evaluation in solid tumors is based on lesion axial diameter measurements. In parallel, MEDIAN will implement an exploratory imaging biomarker based on tumor volume that provides more accurate and earlier information regarding patient response to therapy.
Imaging data will be acquired in at least four clinical sites in Europe and in the US, accounting for a total of 50 patients enrolled.
“We are very proud of this new signed contract, the third one with this leading global biopharmaceutical company; it illustrates the climate of confidence we are developing together”, said Jerome Windsor, VP Pharma Business at MEDIAN. “We are equally enthusiastic about the challenge beyond this study: today, response evaluation criteria for oncology, such as RECIST, have severe limitations. In parallel, medical images embed a tremendous amount of very accurate and clinically relevant information. We, at MEDIAN, have developed a strong scientific and technological expertise to mine this information and setup advanced imaging biomarker. We do believe that such studies, dealing with advanced imaging biomarkers, are now paving the way to the future of cancer management for the benefit of patients”, added Nicolas Dano, Director of Business Development Europe and Asia.
At the same time, MEDIAN has been awarded [*] another project by the same biopharmaceutical company, which could lead to a contract worth €86,000.
Since the beginning of 2013, MEDIAN Technologies has recorded €3.9M (eq. $5.1M) of orders, including €1.0M of firm orders and €2.9M of project awards [*].
[*] A project award notifies a company that their solution has been selected for a given project. A binding contract is then signed within the 18 months following the award, upon confirmation of the upstream clinical results.
[1] RECIST : Response Evaluation Criteria in Solid Tumors – Introduced in 2000 by an International Working Party to standardize & simplify tumor response criteria in oncology trials, RECIST is widely accepted as a standardized measure of tumor response. RECIST criteria has been revised in 2010 (RECIST 1.1. version)