BLUE BELL, Pa.--(BUSINESS WIRE)--VGX Pharmaceuticals today 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 www.vgxp.com.
Contacts
VGX Pharmaceuticals
Kevin W. Rassas, Senior Vice-President,
267-440-4208
Fax: 267-440-4242
Rassas@vgxp.com
www.vgxp.com