VGX Pharmaceuticals today announced it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for Phase I clinical studies of VGX-3200 in late stage cancer patients. VGX-3200 is an injectable DNA plasmid-based therapeutic that expresses human Growth Hormone Releasing Hormone (GHRH) protein. VGX’s innovative DNA delivery technology allows GHRH to be naturally produced and maintained under endogenous physiologic feedback regulation. Treatment for cancer-related cachexia and anemia is the first target for VGX-3200. Additionally, the Company is developing the GHRH technology for a number of other indications including age-related
Studies in different animal models and humans have shown that GHRH has both direct and indirect functions in development, protein metabolism, and maintenance of hematological and immune status under physiological and pathological conditions. The proposed human studies with plasmid-delivered GHRH follow successful studies in dogs with cancer. Administration of GHRH plasmid with VGX’s CELLECTRA™ electroporation device was shown to increase IGF-I levels, ameliorate cachexia, improve anemia, prolong survival, and improve quality of life in dogs with cancer.
“VGX-3200 has the potential to provide novel treatment options for patients suffering from several devastating conditions,” stated Dr. J. Joseph Kim, President and Chief Executive Officer. “VGX will continue to leverage our prolific product development platform to bring several product candidates to clinical evaluation. We plan to file two additional INDs for our SynCon™ product candidates during the first two quarters of 2008: VGX-3100, a therapeutic vaccine for the treatment of cervical cancer and VGX-3400, a pandemic avian flu vaccine.”
Cachexia, an illness affecting up to 5 million people in the United States alone, and its associated disorders are common complications of cancer, aging, acquired immunodeficiency syndrome, chronic kidney or heart failure. Cachexia is one of the most devastating symptoms of cancer and typically results in drastic (greater than 10% of total body weight) weight loss. This complication, which is suffered by up to 75% of cancer patients, can often be fatal before death due to the actual disease. Currently, there is no viable treatment for cachexia.
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, and PENNVAX™-B, a DNA vaccine for HIV infection, which is in 2 separate Phase I clinical trials. The Company’s lead compound for inflammatory diseases, VGX-1027, is also in Phase I clinical trials. VGX’s research pipeline includes a new generation of SynCon™ DNA vaccines and therapeutics as well as the CELLECTRA™ electroporator, a patented DNA delivery device. 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 www.vgxp.com.
About VGXI Inc.
VGXI Inc. is a leading provider of DNA plasmid manufacturing and development services for DNA vaccine and gene therapy research. The Company has an outstanding track record of success in manufacturing plasmid products under cGMP conditions for client companies’ clinical studies in the US and Europe, and its cGMP and non-cGMP products have passed rigorous reviews by several international regulatory agencies. VGXI’s ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and experienced development team. The recently announced research and pre-clinical production services extend the range of high-quality, research grade materials utilizing the same efficient service. This rapid turnaround program provides consistent materials to build a reliable pre-clinical dataset. For information, visit 126.96.36.199/~vgxiico2
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