VGX Announces Initiation of IND-enabling Toxicology Studies for Candidate DNA Vaccine Products
News Aug 20, 2007
VGX Pharmaceuticals has announced that it has initiated IND-enabling pre-clinical toxicology studies for three of its DNA plasmid-based product candidates.
The candidates include vaccines for human papilloma virus for the treatment of cervical cancer (VGX-3100) and avian influenza (VGX-3400), and a therapeutic based on human growth hormone releasing hormone (VGX-3200) for cancer related cachexia.
VGX is conducting the studies in combination with its patented CELLECTRA™ electroporation device and the studies will provide pre-clinical safety data for both the product candidates as well as the device in a GLP environment.
"We are pleased that our Immune Therapeutics program has entered the GLP toxicology stage and has allowed us to fully validate our dynamic vertically integrated product development program for DNA based products," stated Dr. J. Joseph Kim, President and CEO of VGX.
All three DNA plasmid-based products have previously demonstrated efficacy in various animal models. The CELLECTRA™ device delivers DNA plasmids efficiently via the application of constant-current electroporation pulses.
The device has been tested extensively in research studies in a large number of different animal models, including non-human primates, establishing a broad safety, tolerability and efficacy profile.
The current toxicology studies will be completed in early 2008 and Investigational New Drug Applications (INDs) for the three products are expected to be filed in the first half of 2008.
In treating inflammatory bowel disease (IBD), physicians can have a hard time telling which newly diagnosed patients have a high risk of severe inflammation or what therapies will be most effective. Now researchers report finding an epigenetic signature in patient cells that appears to predict inflammation risk in a serious type of IBD called Crohn’s disease.