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VGX Animal Health gets New Zealand approval to market LifeTide SW 5.0, a GHRH therapy for food animals

Blue Bell, PennsylvaniaTuesday, October 16, 2012, 15:00 Hrs  [IST]

VGX Animal Health, a majority-owned subsidiary of Inovio Pharmaceuticals, Inc. has received approval to market LifeTide SW 5.0, the world's first approved growth hormone releasing hormone (GHRH) therapy for food animals, in New Zealand. LifeTide is a once-in-a-lifetime treatment for female pigs (sows) that has demonstrated significant decreases in perinatal mortality of piglets from treated sows compared to untreated sows.

The treatment, which increases the number of weaned piglets and results in greater overall meat production, was previously approved in Australia.

"We've seen that when perinatal mortality is significantly reduced, pork producers can quickly realize production and profit benefits never before imagined," said Dr Douglas Kern, DVM, and vice president of Business Development for VGX Animal Health.

Dr J Joseph Kim, chairman of VGX Animal Health and CEO of Inovio Pharmaceuticals, said, "This approval is another milestone for DNA plasmid therapy, where Inovio leads the world. Our plasmid-based technology platform provided this breakthrough in animal health and has demonstrated in humans its safety and immune responses in therapeutic and preventive vaccines for cancer, HIV, influenza and other infectious diseases in proof-of-principle clinical studies.”

"We are investigating GHRH therapy in other veterinary as well as human disease areas since it has shown promise in treating a broad array of diseases such as cancer, HIV-associated lipodystrophy, diabetes, Alzheimer's and conditions that affect the kidney and heart."

The New Zealand approval is particularly significant in that genetically modified (GMO) products are not allowed in the country. Given the New Zealand stance on GMO technologies, VGXAH's ability to gain market approval for their non-GMO DNA based therapy is a testament to the safety and sustainability of this technology platform. The ability to enhance the genetic potential of the pig without permanently altering its genetic make-up is an important step forward in the effort to feed the United Nation's estimated one billion food-insecure people around the world. VGX Animal Health's accomplishment is an important step in developing technologies to enhance the world's ability to feed a population that will require a doubling of the amount of food we produce within the next four decades. For areas of the world concerned with preserving genetic diversity, this technology offers great promise.

Growth hormone releasing hormone or GHRH is a naturally occurring molecule that stimulates the body's pituitary gland to release growth hormone that it produces every day.

Earlier this year, Inovio reported that a study published in a leading peer-reviewed journal showed that LifeTide SW 1.0, an optimized version requiring only 20 per cent of the dose of the approved LifeTide SW 5.0, demonstrated significant decreases in perinatal mortality, an increase in the number of pigs born alive, and an increase in the weight and number of pigs weaned compared with the control group. Additionally, there was a significant increase in the lifespan of the treated sows in the study. These findings provide further evidence of the potential of the plasmid-based GHRH technology to improve productivity and profitability for pig producers around the world.

VGX Animal Health's GHRH product for pigs, LifeTide SW 5.0, is administered as a once in a lifetime treatment for use in sows of breeding age. 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. LifeTide SW 5.0 is the world's first therapeutic plasmid delivered by electroporation to be approved for use in food animals. The product is approved in Australia and New Zealand.

LifeTide SW 1.0 is an optimized lower-dose DNA construct (1 mg effective dose compared to the 5 mg dose for LifeTide SW 5.0) that has demonstrated the equivalency and performance of higher-dose products.

VGX Animal Health is developing DNA-based therapies for companion and food animals utilizing proprietary plasmid-based DNA delivery and expression technology to optimize an animal's natural biological and immunological potential.

Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases.

 
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