June 17, 2008 -- Fox Chase Cancer Center (Philadelphia, PA) and VisEn Medical (Woburn, MA) are partnering to advance Phase I clinical trials of one of VisEn Medical's "smart" fluorescence activatable imaging agents to enable physicians to identify and characterize early stage disease in oncology patients.
Olympus Medical Systems Corp. (Tokyo, Japan) will provide paired fluorescence laparoscopic imaging systems to enable the detection and evaluation of tumors -- highlighted with VisEn's ProSense -- in patients in the trials. The clinical trials will initially focus on ovarian cancer and are planned to begin next year at Fox Chase Cancer Center.
Under terms of the program, VisEn will develop and submit an Investigational New Drug (IND) application on a clinical analog of its proprietary fluorescence molecular imaging agent, ProSense, which highlights certain enzymatic processes associated with early stage cancer development in vivo.
"These clinical molecular imaging technologies should provide the foundations for earlier and more accurate disease detection, and more importantly, enhanced functional imaging capabilities that will eventually help guide therapeutic interventions," said Michael V. Seiden, MD, Ph.D., President and CEO of Fox Chase Cancer Center.
The ProSense Activatable Imaging Agent platform was developed to provide in vivo readouts of some of the key protease activities known to underlie disease states in oncology, inflammation, and cardiovascular disease. A pre-clinical version of ProSense is currently being used by leading academic institutions and pharmaceutical customers worldwide to image disease-related in vivo protease profiles in pre-clinical research and drug development.
The IND program and the planned Phase I clinical trials are designed to translate the benefits of ProSense into humans, as well as to further develop the multi-channel white light and near infrared fluorescence laparoscopic imaging systems used in collecting and analyzing fused images in real time in the operating room. The planned trial is also designed to gather safety and imaging data for the agent, which will be administered systemically, and to collect preliminary pharmacokinetic information on the metabolism of the agent to support expanded Phase II clinical trials.
In addition to conducting the clinical trials, Fox Chase Cancer Center will invest in the ProSense clinical program through VisEn and will receive certain rights, equity and royalties on future sales.