Overview
IC is engaged in the development and commercialization of a potential treatment for colitis, toxic shock, and laminitis in horses. C10, the lead compound, treats the direct cause of colitis, toxic shock, and laminitis,not just the symptoms. In equine experimental studies, the treatment showed positive results measuring efficacy and demonstrated no significant side effects.
Clinical Trial History
IC has conducted three clinical trials on colitis/toxic shock and has preliminary evidence supporting initiation of a fourth for laminitis. The first two trials were conducted under approved protocols by the Veterinary School at the Univerisdad de Montevideo in Uruguay, S.A. Here C10 was evaluated in horses which: (i) Had experimentally (LPS) induced sub-lethal toxic shock or (ii) Were suffering from operative-induction of peritonitis.
Both of these models are representative of commonly occurring equine colic. During the latter experiments the control horses were given a standard antibiotic treatment regimen whereas the "treatment group" of horses was given C10 plus the standard treatment. These clinical trials demonstrated the potential efficacy, safety and initial feasibility of the C10 treatment.
A third trial evaluating mild toxic shock was conducted at The Ohio State University Department of Veterinary Medicine. The trial consisted of experimentally induced toxic shock by a continuous infusion of lipopolysacaride (LPS), a component of gram-negative bacteria, and a single dose of C10. The LPS in this trial was given to twelve horses to activate the innate immune-induced early symptoms resultant from the inflammatory response leading to toxic shock. All 12 horses receiving LPS developed cardiovascular signs and abdominal symptoms to a greater or lesser degree. Fifty percent (50%) of the C10 treated horses had neither significant cardiovascular or abdominal symptoms. An additional 30 % had attenuated cardiovascular signs. The results supported the potential of C10 use in less severe cases as well as serious cases of toxic shock and peritonitis. These studies again demonstrated the safety of the proposed C10 treatment method.
Current Activities
1) Demonstrate efficacy measuring molecular markers of disease expression in experimentally induced diseases in horses already treated with C10
2) Establish equine testing centers at major universities with Veterinary Schools to evaluate C10 in clinically relevant colic, colitis, toxic shock, and laminitis in horses and foals*
3) Perform pharmacokinetics and toxicity studies at these test centers*
4) Support and contribute to academic papers on equine applications of C10
* (Green indicates in progress)
Management
this project will be pursued by Anthony Schwartz, MS, at Colorado State University. The business goals over the next 18 to 24 months are to establish the clinical efficacy for the treatment of colic and laminitis in horses, addressing instances where torsion of the bowel, peritonitis, post operative peritonitis, sepsis, toxic shock, and/or foot sequellae contribute to mortality and morbidity. In parallel, IC wishes to engage partners to assist in the manufacturing and clinical trial process that will lead to USDA/FDA approval.
Milestones
1) Obtain funding
2) Produce GMP C10 compound
3) Perform additional feasibility and dosing studies in horses and foals afflicted with clinically relevant examples of colic, colitis, peritonitis, sepsis, toxic shock, and laminitis.
4) Perform toxicity and pharmacokinetics studies
5) Engage USDA/FDA in dialogue to assure correct clinical strategy
6) Execute clinical trial that will lead to license approval
7) Obtain market approval for C10 Market Potential
There are 9.2 million horses in the United States and colic is responsible for more deaths (estimated > 25,000 per year) in horses than any other cause except old age. In the United States there are over 500,000 cases of colic per year. The term "colic" means any sort of abdominal pain in the horse, 10 to fifteen percent diagnosed cases of colic are serious and life threatening. Early diagnosis will not always identify such serious cases and higher incidences of disease expression are seen in the most valuable, inbred breeds of thoroughbreds. Morbidity and mortality in horses with laminitis, as illustrated by the unfortunate sequellae afflicting Barbaro, expand this window of opportunity to even a greater extent.
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