VGX Pharmaceuticals Submits Device Master File to FDA for CELLECTRA™ Electroporator
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VGX Pharmaceuticals announced the submission of a Device Master File (MAF) to the U.S. Food and Drug Administration (FDA) for its patented CELLECTRA™ adaptive constant current electroporation device.
The Company has been developing the CELLECTRA™ electroporator as its lead clinical medical 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.
Filing of the MAF, which includes technical, manufacturing, and clinical and non-clinical information about a medical device, 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.
VGX Pharmaceuticals recently completed a pain and tolerability clinical trial in healthy volunteers without the presence of a DNA vaccine demonstrating that electroporation with the CELLECTRA™ device is well tolerated.
“This MAF submission brings the CELLECTRA™ device another step closer to becoming the device of choice for DNA vaccines and therapies,” 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 efficient and scalable cGMP manufacturing facilities.”
VGX Pharmaceuticals plans to file three INDs for its SynCon™ DNA-based product candidates during the first two quarters of 2008: VGX-3100, a therapeutic vaccine for the treatment for cervical cancer; VGX-3200, a therapeutic based on human growth hormone releasing hormone for cancer-related cachexia (wasting or heavy weight loss); and VGX-3400, a pandemic avian flu vaccine.
