NEWS RELEASE - For Immediate Release

New Journal Article Offers In-Depth Analysis of Biological Impact of Celsense’s Cell Labeling Product on Human Dendritic Cells

January 11, 2009 - Pittsburgh, Pennsylvania

Celsense, Inc. has announced the recent publication of data on the first application of perflourocarbon cell labeling and in vivo magnetic resonance imaging (MRI) cell tracking using primary human dendritic cells (DCs). Currently, DCs are of broad interest for a wide variety of immunotherapeutic interventions.

Informa Healthcare’s journal Cytotherapy, the official journal of the International Society for Cellular Therapy (ISCT), has provided early online access to the paper entitled, “Functional assessment of human dendritic cells labeled for in vivo 19F magnetic resonance imaging cell tracking” (Helfer et al. Cytotherapy, 2010; Early Online, 1–13). (Currently available at http://informahealthcare.com/toc/cyt/0/0). This work is a collaborative effort among Celsense, University of Pittsburgh, Carnegie Mellon University, and Radboud University Nijmegen Medical Center.

DCs are increasingly being used as cellular vaccines to treat cancer and infectious diseases. While there have been some promising results in early clinical trials using DC-based vaccines, the inability to non-invasively visualize the location, migration and fate of cells once adoptively transferred into patients is often cited as a potential limiting factor in the advancement of these therapies.

Celsense’s novel perfluorocarbon tracer agent (product “Cell Sense”) was used to label human DCs ex vivo for the purpose of tracking the cells in vivo post-transplant by 19F MRI. The paper provides an assessment of this technology and demonstrates that human DCs were effectively labeled without significant impact on cell viability, phenotype or function. Furthermore, the labeled dendritic cells were clearly detected in vivo by 19F MRI in a model system, with the labeled cells being shown to migrate selectively towards draining lymph node regions within 18 hours after transplant.

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 intended to fund the first translational studies to evaluate Cell Sense for tracking human DCs.

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 workstation software for visualizing and quantifying cells in MRI data sets. Customers include leading pharmaceutical and biotechnology companies and medical research centers worldwide.

About Cell Sense
Cell Sense is a perfluorocarbon 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