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VGX Pharmaceuticals Submits Device Master File To FDA For CELLECTRA(TM) Electroporator

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.

About VGX Pharmaceuticals

VGX Pharmaceuticals is a biopharmaceutical company with small molecule and biologic product candidates for the treatment of infectious diseases, cancer, and inflammatory diseases. The Company's clinical development programs include PICTOVIR™ for HIV infection, which is in Phase II clinical trials, and PENNVAX™-B, a DNA vaccine for HIV infection, which is in 2 separate Phase I clinical trials. The Company's lead compound for inflammatory diseases, VGX-1027, is also in Phase I clinical trials. VGX's research pipeline includes a new generation of SynCon™ DNA vaccines and therapeutics as well as the CELLECTRA™ electroporator, a patented DNA delivery device. The product candidates and technology programs are protected by the Company's extensive global intellectual property portfolio.

VGX Pharmaceuticals





VGX dispozitiv de produse farmaceutice a transmis dosarul la FDA pentru CELLECTRA (tm) Electroporator - VGX Pharmaceuticals Submits Device Master File To FDA For CELLECTRA(TM) Electroporator - articole medicale engleza - startsanatate