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VGX Pharmaceuticals receives FDA approval of IND
for novel DNA vaccine for cervical cancer therapy
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Bell, PA – July 1, 2008 – |
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VGX Pharmaceuticals, Inc. (VGX) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for its DNA vaccine for cervical cancer therapy, VGX-3100. The Company expects to initiate the Phase I clinical study for VGX-3100 in patients in a multi-center study in the third quarter of 2008. More information on this study is available at http://www.clinicaltrials.gov/ct2/show/NCT00685412?term=vgx&rank=1
VGX-3100 is the first of the Company’s several proprietary DNA-based product candidates delivered by its CELLECTRA® electroporation device, which are planned to enter Phase I clinical testing. VGX’s SynCon™ DNA vaccine antigens are designed by aligning numerous primary sequences and choosing the most common and/or relevant amino acid at each site using high-powered and patented approaches. The gene sequences are then further optimized for expression and immunogenicity. The SynCon™ DNA vaccines in combination with the CELLECTRA® delivery device provide greater levels of cross-reactive immune responses than those produced by more traditional vaccines.
“We are pleased with the FDA’s acceptance of our VGX-3100 IND application for treating cervical cancer,” stated Dr. J. Joseph Kim, President and Chief Executive Officer. “This accomplishment further demonstrates the potential and efficiency of our DNA-based product development platform.”
VGX-3100 is a DNA-based therapeutic vaccine that has the potential to treat cervical cancer caused by the human papilloma virus (HPV). VGX-3100 utilizes synthetic consensus sequences based on HPV antigens that offer coverage across different viral sub-types (types 16 and 18), which could potentially treat 71% of all cervical cancers. Prophylactic vaccines for HPV, including Merck’s Gardasil® and GSK’s Cervarix™ have been recently approved and are helping to prevent HPV infection. There is still an unmet need for treating individuals who have previously been exposed to HPV.
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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, PENNVAX™-B for HIV infection, which is in 2 separate Phase I clinical trials, and VGX-1027 for inflammatory diseases, which is in Phase I clinical trials. In addition, the Company has filed INDs for VGX-3100, a DNA therapeutic vaccine for cervical cancer; VGX-3200, a novel DNA therapy that utilizes GHRH for the treatment of cancer cachexia and anemia; and VGX-3400, a DNA preventative vaccine for avian influenza. VGX has established a vertically-integrated DNA Vaccines and Therapies Platform with extensive capabilities including SynCon™ DNA-based product candidates, the CELLECTRA® delivery device, and efficient cGMP plasmid manufacturing. Vertical control over key aspects of product development has enabled the Company to consistently develop multiple product candidates, from bench-to-IND filing, within 1 year. The product candidates and technology programs are protected by the Company's extensive global intellectual property portfolio. More information about VGX can be found at at www.vgxp.com.
Company Contact:
Kevin W. Rassas
Senior Vice President
Tel. 267.440.4208
Fax 267.440.4242
E-mail: Rassas@vgxp.com
www.vgxp.com
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