Inovio Pharmaceuticals Animal Health Subsidiary's GHRH Treatment Approved in New Zealand
Plasmid Therapy Increases Live Births in Pigs; Previously Approved in Australia
BLUE BELL, Pa., Oct. 15, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that its majority-owned subsidiary, VGX Animal Health, 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 makeup is an important step forward in the effort to feed the United Nation's estimated 1 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% 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.
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 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.
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).
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon® vaccines are designed to provide universal cross-strain protection against known as well as newly emergent unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery, have been shown in humans to generate best-in-class immune responses with a favorable safety profile. Inovio's clinical programs include phase II studies for cervical dysplasia, leukemia and hepatitis C virus and phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, our ability to secure new partnerships and collaborations, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2011, our Form 10-Q for the quarter ended June 30, 2012, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.