VGX Animal Health's LifeTide® SW 1.0 Demonstrates Significant Decrease in Perinatal Swine Mortality

THE WOODLANDS, Texas, Sept. 17, 2012 /PRNewswire/ -- VGX Animal Health, a majority-owned subsidiary of Inovio Pharmaceuticals (NYSE MKT: INO), announced today that a study published in a leading peer-reviewed journal showed that LifeTide® SW 1.0, an optimized version requiring only 20% of the dose of the licensed LifeTide® SW 5.0, demonstrated significant decreases in perinatal mortality rate, 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. LifeTide SW 5.0 has received regulatory approval by the Australian Pesticides & Veterinary Medicines Authority and is licensed for use as a single dose treatment for sows of breeding age.

"A revolutionary advance in animal health, LifeTide triggers a natural mechanism that taps into a sow's ability to improve the health and well-being of her offspring. We believe our novel product will be a major factor in addressing the significant number of pigs that even the best pork producers routinely lose to pre-wean mortality. With an anticipated 80% reduction in the needed dose, LifeTide SW 1.0 promises to open new opportunities for this cutting edge technology," said Dr. Douglas Kern, D.V.M, M.S. 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, "LifeTide is one of only four approved products using DNA plasmid technology in the world.  The success of GHRH-based products represents a dramatic advance in animal health utilizing gene therapy. In fact, GHRH therapies have demonstrated efficacy in several animal species including cancer therapy for dogs and cats and has been shown to positively impact the health and milk production of dairy cows. VGX Animal Health also makes use of Inovio's proprietary electroporation-based delivery technology to boost uptake and performance of its products."

Study results were published in the September 2012 (Vol. 73, No 9) issue of the American Journal of Veterinary Research (AJVR) in an article entitled, "Effects of administration of two growth hormone-releasing hormone plasmids to gilts on sow and litter performance for the subsequent three gestations," authored by a team led by Dr. Kern. 

Study researchers observed a number of positive effects of the GHRH treatment, including significant increase in insulin-like growth factor-I concentrations, a decrease in perinatal mortality rate, and an increase in the number of pigs born alive.  There was also an increase in the weight and number of pigs weaned for both groups receiving two novel GHRH-expressing plasmids, compared with values for the control group. Additionally, researchers saw a significant increase in sow lifespan for GHRH-treated females, compared with the control group, during the three gestations after treatment.

Overall, the study showed perinatal mortality was reduced by 10% and 14% and litter weaning weights increased by 13% and 7% for litters of females treated with the optimized plasmid and the licensed plasmid, respectively, compared with results for the untreated control females. Litters of the females treated with the optimized plasmid had significantly higher birth weight, weaning weight, and total weight gain per litter compared with results for the litters of the control females. Sow lifespan was increased for both plasmid treatments. For all three gestations after treatment, the herd removal rate was 44%, 24%, and 24%, respectively, for the untreated control females and females treated with the optimized plasmid and licensed plasmid. Thus, there was a reduction of 44% and 46% for females treated with the optimized plasmid and licensed plasmid, respectively, compared with results for the untreated control females.

Both of the GHRH plasmids provided significant benefits for sow performance and piglet survivability for pregnant and lactating sows and their offspring during the three gestations after treatment, compared with results for untreated control gilts. Use of a novel optimized plasmid reduced the effective plasmid dose in these large mammals.

About LifeTide® Products, SW 1.0 and 5.0

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 was approved in Australia in 2008 by the Australian Pesticides and Veterinary Medicines Authority.

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 the performance of higher-dose products.

About VGX Animal Health

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. The company is a majority-owned subsidiary of Inovio Pharmaceuticals Inc. (NYSE MKT: INO).

This press release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. VGX Animal Health, Inc., which is a majority owned subsidiary of Inovio Pharmaceuticals (NYSE MKT: INO) is providing this information as of the date of this press release, and expressly disclaims any duty to update information contained in this press release.

Forward-looking statements in this press release include, without limitation, express and implied statements relating to VGX Animal Health's (VGXAH) business, plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and pre-clinical and pre-licensing studies. Actual events or results may differ from the expectations set forth herein as a result of a number of risks, uncertainties and other factors, including but not limited to: VGXAH has a history of losses; all of VGXAH's potential animal products are in research and development phases outside of LifeTide® in Australia; no revenues have been generated from the sale of any such products outside of LifeTide® in the Australian market, nor are any such revenues expected for at least the next several years; VGXAH's product candidates will require significant additional research and development efforts, including extensive preclinical and pre-licensing testing; uncertainties inherent in pre-licensing trials and product development programs, including but not limited to the fact that pre-clinical and pre-licensing results may not be indicative of results achievable in other trials or for other indications, that results from one study may not necessarily be reflected or supported by the results of other similar studies, that results from an animal study may not be indicative of results achievable in pre-licensing studies, that pre-licensing testing is expensive and can take many years to complete, that the outcome of any pre-licensing trial is uncertain and failure can occur at any time during the pre-licensing trial process, and that VGXAH's electroporation technology and gene therapies and DNA vaccines may fail to show the desired safety and efficacy traits in pre-licensing trials; all product candidates that VGXAH advances to pre-licensing testing will require regulatory approval prior to commercial use, and will require significant costs for commercialization; the availability of funding; the ability to manufacture gene therapy and vaccine candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by VGXAH or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that VGXAH and its collaborators hope to develop; whether VGXAH's proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; and the impact of the government's proposals to the regulatory environment.

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CONTACT:
Doug Kern, VGX Animal Health, 281-296-7300 ext. 103, [email protected]

SOURCE VGX Animal Health