NEWS RELEASE - For Immediate Release

The First IND Submitted to the US Food and Drug Administration Using Cell Sense in a Clinical Trial

IND submission proposes landmark use of MRI imaging to monitor in vivo biodistribution of a cell therapy

May 10, 2011 - Pittsburgh, Pennsylvania

Celsense, Inc. announced today that investigators at the University of Pittsburgh Cancer Institute (UPCI) have filed an IND application with the US Food and Drug Administration (FDA) to use Cell Sense in a Phase 1 clinical trial. 

This application, involving the use of an autologous dendritic cell vaccine to treat colorectal cancer, is the first FDA submission to use Cell Sense in patients. The application will cross reference data contained the Cell Sense Drug Master File at FDA.

The use of Cell Sense with the cellular product will enable the investigators to non-invasively observe the trafficking of the dendritic cell vaccine after is it is administered to the patient. Investigators believe that the unaided trafficking of dendritic cells to the lymph node is fundamental to the success of this therapeutic strategy. 

“We believe data from this study will lead to improved outcomes for patients receiving live cell vaccines for cancer,” said Charlie O’Hanlon, President and CEO of Celsense.

Autologous cell vaccines for the treatment of cancer have recently enjoyed a resurgence of interest from investors given the FDA’s approval of Dendreon’s PROVENGE for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

“If approved, we believe this will be one of the first FDA-sanctioned use of an imaging label with a cell-based therapy. Such a label is capable of providing investigators with imaging data demonstrating where the cells go, at what volumes, and for how long they stay at the target location,” says cell therapy industry analyst, Lee Buckler, managing director of the Cell Therapy Group.

“The industry has been keen to see these kinds of technologies clinically employed,” continues Buckler, “but different cell-based labels have created their own technical, clinical, and/or regulatory hurdles. We are hopeful that Celsense is now ushering us into a new era where we will eventually be able to use various technologies to monitor and collect valuable data concerning cells after they have been administered as a therapy to a patient.”

This clinical trial has been funded by an RO1 grant from 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.

About Colorectal Cancer (CRC)
CRC is the third leading cancer in the United States and the most common form of gastrointestinal malignancy. CRC accounts for approximately 150,000 new cases annually. Immunotherapeutic interventions using live-cell DC vaccines may potentially be effective in CRC patients. To date, the inability to accurately follow the location of the cells after transfer to the patient is one of the critical bottlenecks in the development and delivery of cancer immunotherapies.

About Cell Sense
Cell Sense (patent-pending) is a fluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Labeled cells are transplanted into the patient enabling researchers and clinicians to non-invasively track the administration and migration of therapeutic and/or diagnostic cells using 19F MRI or MRS. Applications include tracking cells in immunotherapy or regenerative medicine as well as diagnosis of inflammatory sites by tracking selected populations of immune cells.  Using software developed by Celsense, investigators can quantify the number of labeled cells in a user-specified region of interest. It is expected that in vivo cellular imaging will routinely be used to provide a surrogate biomarker for certain cellular therapeutic and drug trials.

About Celsense, Inc.
Celsense, Inc.develops and offers novel pre-clinical and clinical-grade products that enable the non-invasive imaging of cells in vivo using MRI.  Celsense’s mission is to be the standard for cellular imaging in human health.

Contact Information:

Charlie O’Hanlon, President and CEO
Celsense, Inc.