The study, which will employ the CIVO platform to evaluate patients' unique responses to microdoses of cancer drugs, is a collaboration with
'The green light from the FDA for Presage's first exploratory IND represents a major milestone as we seek to revolutionize early drug development through a superior approach to translational oncology,' said
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Earlier this year, Presage announced collaborations with Celgene and BMS for Phase 0 trials with CIVO. Those trials are expected to commence in 2020 following FDA clearance. A recently completed clinical trial to evaluate the safety and feasibility of utilizing the CIVO platform demonstrated that CIVO is well tolerated and highlighted drug-specific tumor cell and microenvironment responses to both small molecule and biologic agents.
About CIVO and Phase 0 Trials
To address the challenges inherent in cancer drug discovery, Presage is advancing a new approach to rapidly evaluate multiple drug candidates and enhance knowledge applicable for future trial design. Exploratory Investigational New Drug studies, also known as Phase 0 trials, allow for the evaluation of minute amounts of drugs in patients to assess pharmacodynamic effects. CIVO is a patented platform that enables intratumoral microdosing and analysis of multiple cancer agents.
About Presage
Presage Biosciences is an oncology company pioneering a new drug development approach to assess novel therapeutics and combinations directly in human tumors with its patented CIVO intratumoral microdosing platform. The CIVO platform is intended to enable simultaneous assessment of responses to multiple drugs or drug combinations directly in a single tumor while still in a patient's body. Presage also partners with oncology-focused pharmaceutical companies through strategic alliances to provide preclinical data to discover effective drug combinations. Presage is privately held and based in
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