VGX Pharmaceuticals Announces Successful Completion Of The First Human Study To Assess The Tolerability Of CELLECTRA™ Electroporator

Main Category: Immune System / Vaccines
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 29 Dec 2007 - 1:00 PDT

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VGX Pharmaceuticals announced today the successful completion of its first study to assess the tolerability of VGX's patented CELLECTRA™ electroporation device in humans. Ten healthy adult volunteers were treated with CELLECTRA™ device and were asked to report the level of discomfort they experienced immediately after electroporation and at various times thereafter. The procedure was generally well tolerated. On average, the patients reported a moderate level of discomfort during the procedure. However, the discomfort was short-lived, with comfort levels approaching baseline levels within 30 minutes following the procedure. Other complaints were mild and did not require any treatment.

Numerous preclinical efficacy studies have shown that delivery of VGX's DNA products with the CELLECTRA™ device resulted in therapeutic and protective immune responses that are unachievable by other treatment or vaccine methods.

"The completion of this Human Tolerability Study is a major milestone for VGX Pharmaceuticals," stated Dr. J. Joseph Kim, President and Chief Executive Officer. "This is just the first step in our aggressive strategy to develop a potent and prolific DNA-based drug and vaccine development platform."

Over the years, VGX Pharmaceuticals has established itself as a leading developer and manufacturer of DNA plasmid-based vaccines and therapies. The Company has built extensive, vertically-integrated capabilities including SynCon™ DNA-based product candidates, the CELLECTRA™ delivery device, and efficient cGMP manufacturing facilities for its own product supplies and for contract manufacturing.

PENNVAX™-B, the first of VGX Pharmaceuticals SynCon™ DNA vaccine candidates, is already in Phase I clinical trials as a preventative vaccine for HIV infection. VGX Pharmaceuticals plans to file three additional INDs for its SynCon™ DNA vaccine 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 (GHRH) for cancer-related cachexia (wasting or heavy weight loss); and VGX-3400, a pandemic avian flu vaccine. All of these vaccines are delivered by the CELLECTRA™ device.

VGX Pharmaceuticals operates a 500-liter scale cGMP DNA plasmid manufacturing facility in The Woodlands, Texas. In addition, the Company has initiated a project to build and operate a 3000-liter cGMP manufacturing facility in Korea with its affiliate, VGX International.

http://www.vgxp.com