Celsense

 

 

NEWS RELEASE - For Immediate Release

Celsense, Inc Files Health Canada Regulatory Submission

August 24, 2012 - Pittsburgh, Pennsylvania

Celsense, Inc. announced today that it opened a Drug Master File (DMF) with Health Canada for its lead in vivo imaging reagent, Cell Sense CS-1000 (Cell Sense). A DMF provides key information about the quality of components, materials and manufacturing processes involved in producing medical devices and human drugs, including related products such as imaging reagents like Cell Sense. The main objective of a DMF is to support regulatory filings, such as the filing of Investigational New Drug Applications (INDs) by investigators incorporating the use of Cell Sense in their clinical trial. In Canada, the DMF will be used to support Clinical Trial Applications (CTA) submitted to Health Canada

“Multiple customers in Canada are currently planning to use Cell Sense to track the fate of therapeutic cells administered in new clinical trials. Making this regulatory filing available for investigators in Canada is critical to the adoption of Cell Sense,” said Amy Wesa, Director of R&D at the company.

Celsense previously opened a DMF for Cell Sense with the U.S. FDA to support IND submissions in the U.S. The FDA has allowed the use of Cell Sense in a pending dendritic cell therapy clinical trial for colorectal cancer. The company is preparing similar submissions to support additional clinical trials in Europe and Oceana.

Cell Sense is a fluorocarbon ex vivo cell label that enables investigators and clinicians to non-invasively track delivery, migration, and persistence of therapeutic and diagnostic cells in vivo using Magnetic Resonance Imaging (MRI). The emulsion is a self-delivering label that requires no exogenous transfection agent. Cell Sense enables investigators the ability to identify, quantify, and follow pre-labeled cells in vivo using fluorine (19F) magnetic resonance imaging (MRI) technologies. 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
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
charlie@celsense.com