NEWS RELEASE - For Immediate Release

Celsense, Inc Receives Funding to Develop Dual Mode Imaging Agent

NIH funds development of a dual mode version of the Cell Sense MRI imaging agent, used in the routine validation of the cellular imaging platform

Pittsburgh, PA (October 19, 2009) —Celsense, Inc. announced today that it has received NIH STTR funding to develop a commercially–scalable fluorescent version of its lead product Cell Sense.

Cell Sense is a fluorocarbon ex vivo cell label that enables investigators and clinicians the ability to non–invasively track therapeutic and diagnostic cells in vivo using Magnetic Resonance Imaging (MRI). The emulsion is a self–delivering nanoparticle that requires no exogenous transfection agent and is stable within cells. Cell Sense emulsion permits investigators to identify, quantify, and follow pre–labeled cells in vivo using fluorine (19F) MRI technologies.

“We believe a true dual mode agent (i.e., detectable by both 19F MRI and fluorescence) will be important for the adoption of the Cell Sense platform in both preclinical and clinical studies,” states Charlie O’Hanlon, company President and CEO.  “In preclinical studies it will allow investigators to positively identify the fate and phenotype of labeled cells using histology or flow cytometry following 19F MRI, days and weeks after cell transfer.”

Moreover, this dual mode agent is expected to encourage clinical adoption of Cell Sense. The new agent is used to quantitatively validate the amount of Cell Sense delivered to each patient’s cells following the ex vivo labeling procedure. The dual mode agent is not delivered into patients directly, but used in the clinic as an in vitro diagnostic in a cell subset to ensure consistent ex vivo Cell Sense labeling of patient–derived cells; this validation step is accomplished using a simple and quick microplate reader measurement. 

This newly funded STTR project represents an industrial–academic collaboration with Dr. Jelena M. Janjic, Assistant Professor of Pharmaceutics in the Division of Pharmaceutical Sciences, Mylan School of Pharmacy, Duquesne University.

Cell Sense has been designated a drug by the FDA to be reviewed and regulated by the Center for Biologics Evaluation and Research (CBER). It is the subject of a Drug Master File with FDA, and an Active Substance Master File (ASMF) is currently being reviewed by the European Medicines Agency (EMEA).  The company also recently announced that it was a co-recipient on a 4–year $1.95M grant from the NIH to fund pilot human studies utilizing Cell Sense.   

Celsense, Inc. has three reagents for MRI imaging of cells currently on the market for pre–clinical research and discovery. The company also offers the Voxel Tracker software that visualizes and analyzes the Cell Sense MRI data set. Customers include leading pharmaceutical and biotechnology companies and medical research centers worldwide. 

About Cell Sense
Cell Sense 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 cell therapy and drug trials.

About Celsense, Inc.
Celsense, Inc. offers products that enable the non-invasive imaging of cells in vivo using MRI.  The mission of the company is to be the standard for cellular imaging in human health.

Contact Information:

Charlie O’Hanlon, President and CEO
Celsense, Inc.
(412) 263-2870