Fox Chase Cancer Center Enters Partnership To Advance First Clinical Trials Of Novel Fluorescence Molecular Imaging Technologies
Center's Investment in Partnership Spurs Active Steps to Manage Potential or Perceived Conflict of Interest
PHILADELPHIA (June 16, 2008) - In a separate statement issued today, Fox Chase Cancer Center and VisEn Medical announced a partnership 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. will provide paired fluorescence laparoscopic imaging systems to enable the detection and evaluation of ProSenseTM 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 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. 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.
Recognizing that Fox Chase Cancer Center's investment in the partnership raises a potential or perceived conflict of interest, the Center has taken active steps to manage any such conflict of interest.
The mission of Fox Chase Cancer Center is to improve cancer care for its patients and all cancer patients, and this is Fox Chase's primary interest in the partnership. Its investment in the partnership creates a secondary financial interest, however, presenting a potential or perceived conflict of interest.
To actively manage this potential or perceived conflict of interest, Fox Chase contracted with bioethicist Arthur L. Caplan, Ph.D., director of the Center for Bioethics at the University of Pennsylvania, for counsel. On the advice received, Fox Chase Cancer Center will take the following steps to manage any potential or perceived conflict of interest associated with the partnership:
- Utilize an independent Institutional Review Board (IRB) to review the research protocols and determine whether such research protocols adequately protect the human subjects
- Utilize an independent Data Safety Monitoring Board to review the data from the research
- Utilize an independent biostatistician to review the data from the research
- Find a Principal Investigator (PI) at the Center who has no fiduciary or management role at the Center
- Separate clinical and research discussions from business discussions between the Center and VisEn
- Separate clinical and research discussions from business discussions within the Center
- Disclose institutional financial interest to human subjects prior to obtaining consent to participate in the research
- Ensure that management oversight of the research is limited to only that extent necessary and consistent with the way management oversees all other research
Importantly, because Fox Chase Cancer Center's current president and CEO, Michael V. Seiden, M.D., Ph.D., was involved in research related to ProSense while at Massachusetts General Hospital prior to his appointment at Fox Chase and maintains an ongoing interest in this research, he will act solely as the Center's CEO and will have no role in the continuing research beyond his normal role in overseeing the Center's research enterprise.
We believe that taking these steps will be sufficient to manage any potential or perceived conflict of interest presented by the partnership. This statement describing the steps taken will be publicly available on the Center's web site for the duration of the partnership.
Fox Chase Cancer Center, part of Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase also was among the first institutions to receive the National Cancer Institute’s prestigious comprehensive cancer center designation in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are routinely recognized in national rankings, and the Center’s nursing program has achieved Magnet status for excellence three consecutive times. Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research and oversees programs in cancer prevention, detection, survivorship, and community outreach. For more information, call 1-888-FOX-CHASE (1-888-369-2427).