Celsense, Inc., announced that investigators at the University of Pittsburgh Cancer Institute (UPCI) have received authorization from the US Food and Drug Administration (FDA) to use its Cell Sense reagent in a phase I clinical trial.
This Investigational New Drug (IND) authorization, involving the use of an autologous dendritic cell vaccine to treat colorectal cancer, is the first FDA authorization to use Cell Sense in patients to visualize the delivery and trafficking of the therapeutic cells. Visualizing cell migration will aid in optimizing the route of delivery for this emerging immunotherapeutic approach. UPCI’s IND cross-references data contained in the Cell Sense FDA Drug Master File opened by Celsense Inc., in May 2009.
“We have always been confident about the safety profile of Cell Sense, yet many of our prospective customers have expressed concern that the FDA would delay the regulatory progress of their therapeutic candidates if an imaging modality was introduced. We believe that the authorization of this IND will alleviate such concerns and lower the barriers for adoption. The agency’s tangible support for bringing new technologies to bear in the translation of cell-based therapeutics is very encouraging,” said Charlie O’Hanlon, president and CEO of Celsense.
This clinical trial has been funded by the National Cancer Institute at the National Institutes of Health. The co–investigators at UPCI are Drs Pawel Kalinski and David Bartlett. Other investigators include Dr Eric Ahrens at Carnegie Mellon University and Dr Amy Wesa at Celsense.
Cell Sense is a novel perfluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Labelled cells are transplanted into the patient enabling researchers and clinicians to non-invasively track the administration and migration of therapeutic cells using MRI. Applications include tracking cells in immunotherapy or regenerative medicine as well as the diagnosis of inflammatory sites by tracking selected populations of immune cells. Using Voxel Tracker software developed by Celsense, investigators can quantify the number of labelled cells in a user-specified region of interest. It is expected that in vivo cellular imaging will routinely be used to provide a surrogate marker for certain cell therapy and drug trials.
Celsense Inc. offers products that enable the non-invasive imaging of inflammation and transplanted cells using MRI. The mission of the company is to be the standard for cellular imaging in human health.