Press Release- 31 August 2009
New Braasch Biotech Vaccine Technology Promises Greater Livestock Productivity and
Obesity Treatment Without Drugs
CHICAGO, August 31, 2009 - Braasch Biotech LLC today announced that based on initial testing its lead vaccine candidates for Livestock Productivity and Companion Animal Obesity show benefits in treating numerous Growth Hormone and IGF-1 responsive disorders in animals.
A new vaccine technology that stimulates the body to release more of its own Growth Hormone ("GH") and Insulin Growth Factor 1 ("IGF-1") is expected to open a new world of vaccine options for enhancing livestock productivity and also create specialized vaccines to treat obesity in dogs and cats. Braasch Biotech LLC announced today that they have successfully created a second-generation vaccine technology specifically designed to generate a high level of antibodies against somatostatin, the inhibiting hormone that controls the release of GH. The vaccine's mode of action is to generate highly specific antibodies which attenuate but do not entirely eliminate the mostly inhibitory actions of somatostatin, which helps the body to continue to release more of its own GH and IGF-1. Braasch's innovative approach allows the body to do this on its own without having to use "drugs" and thereby presents important new treatment options for veterinary medicine. Researchers have been working unsuccessfully for over two decades to make early versions of somatostatin vaccines sufficiently effective to be commercialized. Building on the pioneering approaches originally invented and patented by Russian scientists, Braasch and its science collaboration team created a novel second-generation vaccine technology which dramatically improves the effectiveness of the first-generation prototype vaccine. Besides refining the vaccine and its formulation, Braasch, in conjunction with the University of Iowa's Center for Biocatalysis and Bioprocessing, has developed scalable manufacture and isolation processes to provide uniform vaccine for laboratory testing. The new vaccine is designed for once-per-month treatment versus daily treatment regimens for current canine obesity drugs and injections of the drug Posilac® (rbST) which typically require injections every 14 days in lactating dairy cows.
To date the company has established proof-of-concept studies in independent mouse obesity models and in livestock productivity and growth studies. Its lead veterinary vaccine candidates are:
Somatovac™- (Dairy) Productivity Vaccine to compete with the drug Posilac™(rbST)
Somatovac™- (Swine) Productivity Vaccine for grower pigs to improve feed efficacy and average daily gain
(Canine) - Obesity Vaccine to treat obesity in dogs
(Feline) - Obesity Vaccine to treat obesity in cats
In addition to providing significant new economic benefits, the company believes that a natural non-hormone vaccination approach provides a more universally accepted method for producers and consumers. With a little more than 20% of US dairy producers using rbST, the market growth potential in the diary segment is significant in the US alone. A recent study at Cornell University demonstrated that improving milk production efficiency by up to 16% (through the use of rbST) could deliver stunning environmental benefits and dramatic reductions in green house gas emissions. For example, every 1 million cows treated would enable the same amount of milk to be produced by 157,000 fewer cows, saving 491,000 tonnes of feed corn, 158,000 tonnes of soybeans using approximately 540,000 less acres of land. The study also demonstrated that the green house gas reductions would be equivalent to planting 300 million trees or removing 400,000 cars from road for every 1 million cows treated. With 9 million dairy cows in the US, and another 25 million in the EU, the potential environmental benefits for improving milk production are enormous.
The company announced the results of its second-generation vaccine, the first and only somatostatin vaccine technology of its kind. In an independent study, the efficacy of the Braasch vaccine was evaluated in a Diet Induced Obesity (DIO) mouse model (C57BL/6J male mice, The Jackson Laboratory, Bar Harbor, Maine), a model which represents one of the most frequently used and published mouse models for human obesity and Type 2 Diabetes.
All mice were kept on a 60 kcal% fat diet for 6 weeks prior to the start of the study, and for the duration of the study. A normal mouse diet is 10 kcal% fat. The entire study was conducted at The Jackson Laboratory-West (Sacramento, CA). Individual data was recorded for mean weights, food intake and IGF-1 levels. Results indicated that placebo vaccinated controls gained significantly more weight than the vaccinated mice. Even more impressive was that during a continual feeding of the high fat diet, a similar amount of food intake was observed in all mice. "The data set shows that the weight gain phenotype can be reduced in obese mice by the Braasch vaccine treatment. The observed in vivo effects of the vaccine are similar to those of reference compounds in published DIO studies in the literature. The preclinical results suggest the therapeutic potential of this vaccine as a drug candidate for the treatment of type 2 diabetes and obesity," stated Dr. Pali Kaur, the study director at The Jackson Laboratory-West in charge of this efficacy study.
While all mice ate a diet with 6 times the fat content of a normal diet, at the conclusion of the study vaccinated mice gained less than half the weight of placebo vaccinated mice. In terms of human weight, this is equivalent of a 200 pound individual gaining 30 pounds on a high fat diet, while the vaccinated individual would only gain between 8-14 pounds.
Circulating IGF-1, which mediates fat burning, was measured at 21 days after the second vaccination. While there was no statistically significant difference in circulating IGF-1 between the vaccinated mice and the placebo vaccinated controls, one experimental group did have measurably elevated IGF-1 levels compared with control mice.
"This second-generation vaccine technology could become a diverse pipeline of blockbuster vaccines for improving livestock productivity and treating companion animal obesity. We believe that using a vaccine to help the individual animal produce more of its own GH or IGF-1 represents valuable new alternatives for animal health," stated Dr.Keith Haffer, President and CEO of Braasch Biotech. "Our next steps are to advance the potential value of our technology and seek development partners to ultimately address the tremendous worldwide need for improving efficacy in livestock and treating conditions such as obesity in dogs and cats."
Recent developments such as the EU regulatory approval of Pfizer's ImprovacTM(Anti-GnRF) Boar Taint Vaccine has set an important precedent for the EU acceptance of vaccines which are designed to control specific hormones in livestock. "We believe this is a positive sign for the future regulatory acceptance of our somatostatin vaccine technology in the EU," stated Dr. Haffer.
In addition to holding the exclusive worldwide license for an existing US patent, the company has also recently expanded its exclusive intellectual property position with its second-generation somatostatin vaccine technology including four separate US and PCT filings and anticipate several additional filings.
About Braasch Biotech LLC.
Braasch Biotech, LLC is a privately held preclinical-stage vaccine company that utilizes chimeric somatostatin proteins in optimized adjuvant systems for immunologically increasing endogenous Growth Hormone and Insulin-like Growth Factor-1 (IGF-1). The company is based in South Dakota with headquarters located in Garretson and laboratories in Sioux Falls. Additional affiliations in California, Iowa and Colorado.