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.