VGX Pharmaceuticals, Blue Bell, Pa., has announced that 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 CEO. "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's 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.
For more information, visit http://www.vgxp.com or call
267/440-4208.
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