VGX Pharmaceuticals Receives FDA Approval Of IND For Novel DNA Vaccine For Cervical Cancer Therapy

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Immune System / Vaccines;  Regulatory Affairs / Drug Approvals
Article Date: 03 Jul 2008 - 5:00 PDT

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VGX Pharmaceuticals, Inc. (VGX) announced 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 here.

VGX-3100 is the first of the Company's several proprietary SynCon™ DNA vaccine candidates delivered by its CELLECTRA® electroporation device planned to enter Phase I clinical testing. 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.

About VGX Pharmaceuticals

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

VGX Pharmaceuticals