A Medical Device Daily

Fox Chase Cancer Center (Philadelphia) and VisEn Medical (Woburn, Massachusetts) reported a partnership to advance Phase I clinical trials of one of VisEn's "smart" fluorescence activatable imaging agents to enable physicians to identify and characterize early stage disease in oncology patients.

Olympus Medical Systems (Tokyo) will provide paired fluorescence laparoscopic imaging systems to enable the detection and evaluation of ProSense highlighted tumors in patients in the trials. The clinical trials will initially focus on ovarian cancer and are planned to begin in 2009 at Fox Chase.

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. In addition to conducting the clinical trials, Fox Chase will invest in the ProSense clinical program through VisEn and will receive certain rights, equity and royalties on future sales.

"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 Seiden, MD, PhD, president/CEO of Fox Chase.

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.