VGX Animal Health, Inc. (VGXAH), a developer of cutting edge technologies for animal health applications, announced today the approval by the Australian Pesticides and Veterinary Medicines Authority (APVMA) of LifeTide™ SW 5, the Company’s leading Growth Hormone Releasing Hormone (GHRH) product for swine therapy. LifeTide™ SW 5 is an injectable DNA plasmid encoding for porcine GHRH, and is administered as a once in a lifetime treatment for use in sows of breeding age to increase the number of piglets weaned. Licensing studies completed in Australia demonstrated a significant decrease in perinatal mortality and morbidity, resulting in an increase in sow productivity and the number of pigs weaned per sow. The complete approval can be viewed on the APVMA web site (http://services.apvma.gov.au).
The approval by the APVMA opens the way for commercial sale of LifeTide™ SW 5 in Australia. In addition, VGXAH has submitted an application for approval in New Zealand, and plans to seek approval in several other countries in South East Asia including The Philippines and Indonesia. The Company has also initiated studies to support regulatory approval of this technology in other major markets, including the United States and China.
Douglas R. Kern, D.V.M., M.S., Vice President of Business Development, stated, “The approval of this ground-breaking technology is a tremendous accomplishment for the Company and will benefit swine producers in Australia and eventually worldwide. This important milestone will help VGX Animal Health develop additional pioneering applications of the GHRH product
platform for other animal species.”
LifeTide™ SW 5 is delivered to the target tissue by direct intramuscular injection followed by a process called electroporation, which increases the efficiency of DNA uptake by the targeted cells. In previously published studies in peered-reviewed journals, the VGXAH research team under the direction of Dr. Ruxandra Draghia-Akli demonstrated significant beneficial effects of this technology in pigs and numerous other species. VGX Animal Health has an exclusive veterinary-use license for the CELLECTRA™ electroporation device from VGX Pharmaceuticals, Inc. (VGXP), its parent Company. The device will be used for delivery of LifeTide™ SW 5 and other products in development.
Dr. J. Joseph Kim, Chairman of VGX Animal Health, and President and CEO of VGX Pharmaceuticals, stated, “The APVMA approval is an important validation of our ability to use cutting edge DNA-based technology to improve the health, welfare and productivity of the world’s food and companion animal populations. Furthermore, our work in animals could be an important stepping stone for developing our technologies for human medicine.”
VGX Pharmaceuticals plans to file an investigational new drug (IND) application for the human version of GHRH as a therapy for treating cachexia (wasting or heavy weight loss) in cancer patients in the first quarter of 2008.
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 preventing HIV infection, which is in Phase I clinical trials. In addition, VGX is planning to initiate Phase I clinical studies for VGX-1027, its lead compound for inflammatory diseases. 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
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 188.8.131.52/~vgxiico2
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