Nanotechnology Now

Our NanoNews Digest Sponsors





Heifer International

Wikipedia Affiliate Button


android tablet pc

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.

####

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

Copyright © PRWeb

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Imaging electric charge propagating along microbial nanowires October 20th, 2014

Design of micro and nanoparticles to improve treatments for Alzheimers and Parkinsons: At the Faculty of Pharmacy of the UPV/EHU-University of the Basque Country encapsulation techniques are being developed to deliver correctly and effectively certain drugs October 20th, 2014

Physicists build reversible laser tractor beam October 20th, 2014

Removal of Limitations of Composites at Superheat Temperatures October 20th, 2014

Imaging

New Grand ARM Transmission Electron Microscope Offers Highest Commercially-Available Atomic Resolution of 63 Picometers October 17th, 2014

Nanotronics Imaging Releases nSPEC® 3D, Powerful Microscope That Captures 3D Images at Nanoscale, in Lightning Speed: Company Unveils Design at American Chemical Society 2014 International Elastomer Conference October 14th, 2014

BSA Distinguished Lecture Today, 10/14: 'LCLS: A Stunning New View Through X-ray Laser Eyes' October 14th, 2014

The Körber Foundation congratulates Stefan Hell on winning the 2014 Nobel Prize October 10th, 2014

Govt.-Legislation/Regulation/Funding/Policy

Crystallizing the DNA nanotechnology dream: Scientists have designed the first large DNA crystals with precisely prescribed depths and complex 3D features, which could create revolutionary nanodevices October 20th, 2014

Imaging electric charge propagating along microbial nanowires October 20th, 2014

HP Supercomputer at NREL Garners Top Honor October 19th, 2014

First Canada Excellence Research Chair gets $10 million from the federal government for oilsands research at the University of Calgary: Federal government announces prestigious research chair to study improving oil production efficiency October 19th, 2014

Nanomedicine

Design of micro and nanoparticles to improve treatments for Alzheimers and Parkinsons: At the Faculty of Pharmacy of the UPV/EHU-University of the Basque Country encapsulation techniques are being developed to deliver correctly and effectively certain drugs October 20th, 2014

Non-Toxic Nanocatalysts Open New Window for Significant Decrease in Reaction Process October 19th, 2014

European Commission opens the gate towards the implementation of Nanomedicine Translation Hub October 16th, 2014

Tuning light to kill deep cancer tumors: Nanoparticles developed at UMass Medical School advance potential clinical application for photodynamic therapy October 15th, 2014

Announcements

Imaging electric charge propagating along microbial nanowires October 20th, 2014

Design of micro and nanoparticles to improve treatments for Alzheimers and Parkinsons: At the Faculty of Pharmacy of the UPV/EHU-University of the Basque Country encapsulation techniques are being developed to deliver correctly and effectively certain drugs October 20th, 2014

Physicists build reversible laser tractor beam October 20th, 2014

Removal of Limitations of Composites at Superheat Temperatures October 20th, 2014

Grants/Awards/Scholarships/Gifts/Contests/Honors/Records

Crystallizing the DNA nanotechnology dream: Scientists have designed the first large DNA crystals with precisely prescribed depths and complex 3D features, which could create revolutionary nanodevices October 20th, 2014

QD Vision Wins Prestigious Presidential Green Chemistry Challenge Award from the U.S. Environmental Protection Agency October 16th, 2014

Beyond LEDs: Brighter, new energy-saving flat panel lights based on carbon nanotubes - Planar light source using a phosphor screen with highly crystalline single-walled carbon nanotubes (SWCNTs) as field emitters demonstrates its potential for energy-efficient lighting device October 14th, 2014

Unique catalysts for hydrogen fuel cells synthesized in ordinary kitchen microwave oven October 14th, 2014

NanoNews-Digest
The latest news from around the world, FREE





  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More














ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







© Copyright 1999-2014 7th Wave, Inc. All Rights Reserved PRIVACY POLICY :: CONTACT US :: STATS :: SITE MAP :: ADVERTISE