VGX Pharmaceuticals Announces Filing Of Device Master File Amendment With The FDA For CELLECTRA Device – Intradermal Electroporation (ID-EP)

February 16, 2009 at 11:00 am Leave a comment


VGX Pharmaceuticals announced the filing of a Device Master File (MAF) amendment with the U.S. Food and Drug Administration (FDA) for its patented CELLECTRA® adaptive constant current electroporation device for use with intradermal electroporation (ID-EP). The Company has been developing the CELLECTRA® device as its lead clinical device for delivering DNA vaccine and therapy products. Numerous preclinical efficacy studies have shown that delivery of DNA-based product candidates with the CELLECTRA® device optimizes DNA uptake and its subsequent expression in the target tissue, and results in enhanced immune responses in animals.




The company previously filed a MAF in January 2008 covering the use of the CELLECTRA® electroporation device for intramuscular (IM-EP) delivery of DNA. The present filing covering intradermal EP is an add-on to the previously filed MAF. Filing of the amended MAF, which includes technical, manufacturing, and non-clinical information about the medical device covering both ID-EP and IM-EP, marks an important milestone for VGX Pharmaceuticals. It facilitates the FDA review of the CELLECTRA® device when Investigational New Drug (IND) applications for DNA-based product candidates are filed that reference its use.




The company has initiated Phase I studies with the IM-EP device used in conjunction with its therapeutic cervical cancer vaccine (VGX-3100). Separately, in a study involving 10 healthy volunteers administered with saline followed by IM-EP from this device, the CELLECTRA® device was found to be generally safe and well tolerated.




In October 2008, VGX was awarded a $23.5 million contract, by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, to develop a preventive HIV DNA vaccine candidate in conjunction with its constant current electroporation technology for ID delivery of DNA vaccines. The company is presently focused on optimizing the combination of the HIV vaccine candidate and ID delivery parameters in pre-clinical studies under the contract.




“The addition of the ID delivery to the MAF submission for the CELLECTRA® device provides us and our partners with different choices for the optimal delivery of DNA vaccines and therapies based on the desired target specific immune responses,” stated Dr. J. Joseph Kim, President and Chief Executive Officer. “Our aggressive development strategy will continue to validate the value of our vertically-integrated DNA Vaccines and Therapeutics Platform, which includes SynCon™ DNA-based product candidates, the CELLECTRA® device, and access to efficient and scalable cGMP manufacturing facilities.”




The Company has entered into a definitive merger agreement with Inovio Biomedical Corporation (INO: NYSE Alternext).



About VGX Pharmaceuticals




More information about VGX can be found at http://www.vgxp.com.



VGX Pharmaceuticals

[Via http://www.medicalnewstoday.com]

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Entry filed under: Uncategorized.

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