New vaccine technology may prove beneficial for treating IGF-1 responsive disorders

Braasch Biotech LLC announces its lead vaccine for Obesity, Growth Hormone Deficiencies may have beneficial use for numerous IGF-1 responsive disorders such as diabetes, heart disease and Rett Syndrome based on initial preclinical testing in a mouse model.

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 treatment options for growth hormone deficiencies, obesity, specific types of diabetes as well as for a potentially long list of IGF-1 responsive neurological disorders. Braasch Biotech LLC announced today that they have successfully created a vaccine technology specifically designed to generate a high level of antibodies against somatostatin, the inhibiting hormone that controls the release of Growth Hormone. 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 a new treatment option for human 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 treatment regiments using Growth Hormone Drugs which typically require daily injection.

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 using the 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 vaccine technology now opens the door to new vaccine treatments for growth hormone deficiency, obesity, and diabetes as well as potentially several other important IGF-1 responsive neuronal disorders such as Rett Syndrome," stated Dr Keith Haffer, President and CEO of Braasch Biotech. "We are seeking development partners to advance the potential value of our technology and ultimately address the many patients in the world suffering from specific disorders in which a vaccine treatment could help."


Braasch Biotech LLC


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