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Home > Press > Celsense, Inc Files FDA & EMEA Regulatory Submissions: FDA accepts Drug Master File and EMEA receives Active Substance Master File for Cell Sense in vivo imaging agent

Abstract:
Celsense, Inc. announced today it has reached a critical milestone in the push to market for its lead in vivo imaging reagent, Cell Sense CS-1000 (Cell Sense).

Celsense, Inc Files FDA & EMEA Regulatory Submissions: FDA accepts Drug Master File and EMEA receives Active Substance Master File for Cell Sense in vivo imaging agent

Pittsburgh, PA | Posted on October 13th, 2009

Celsense filed a Drug Master File (a "DMF") with CBER earlier this year which the Agency has now accepted. An FDA Drug Master File 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 the filing and obtaining of Investigational New Drug Applications (INDs) by investigators incorporating the use of Cell Sense in their clinical trial.

Additionally, Celsense last week submitted an Active Substance Master File (ASMF) with the European Medicines Agency (EMEA) serving the same function within the European regulatory framework and assisting European investigators in similar fashion.

"Having these regulatory filings available for investigators to reference in their clinical testing applications is critical to the rapid and widespread adoption of our in vivo imaging reagents," said Charlie O'Hanlon, company President and CEO.

Indeed, the company announced earlier this year that the company was one of the recipients on a 4-year $1.95M grant from the National Institutes of Health intended to fund the first studies to evaluate Cell Sense in clinical use.

"Several customers are now planning to incorporate the use of Cell Sense in new and existing INDs," stated O'Hanlon, "and having a DMF/ASMF for them to reference will encourage product adoption, shorten the qualification process for customers, and meet our corporate goal of having the first imaging reagent formally approved for non-invasive, human clinical in vivo tracking of therapeutic and diagnostic cells."

In October 2007, the U.S. FDA concluded, in response to the company's request for designation, that Cell Sense is a drug that will be reviewed and regulated by the Center for Biologics Evaluation and Research (CBER) under the new drug provisions of the Federal Food, Drug, and Cosmetic Act (the Act).

Cell Sense is a fluorocarbon ex vivo cell label that enables investigators and clinicians the ability to non-invasively track the 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 at lysosomal pH levels within the cell. Cell Sense emulsion enables investigators the ability to identify, quantify, and follow pre-labeled cells in vivo using fluorine (19F) magnetic resonance imaging (MRI) technologies.

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

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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.

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 V-Sense

V-Sense is an injectable fluorocarbon MRI tracer agent that labels leukocytes in situ, enabling the direct, non-invasive observation of immune system response and localized inflammation. Applications include observing change in immune system response to therapeutics and mapping localized disease such as certain cancers and infections. V-Sense can also be used to detect the partial pressure of oxygen in tissues, an important biomarker in cancer research and treatment

About Gene Sense

Gene Sense is a reporter gene that causes cells to express a metallic protein in vivo that is detectable in MRI. Applications for Gene Sense include imaging transplanted cells and vector delivery.

For more information, please click here

Contacts:
Charlie O’Hanlon
Celsense, Inc.
(412) 263-2870

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