The starting material for Salient’s CASAD™ is a unique, well-characterized inorganic mineral proven to adsorb a range of toxins and inflammatory proteins commonly associated with diarrhea and other GI-related conditions. This mineral has been designated by the FDA as a Generally Recognized as Safe (GRAS) substance.
This mineral’s safety has been shown in multiple human trials. In addition, an independent study at Gulf Coast Veterinary Specialists (GCVS) demonstrated promise of its efficacy in treating CTID. In this study 100% of the cancer-bearing dogs benefited from treatment and, in 65% percent of the cases, the intractable diarrhea was resolved completely within 48-72 hours. Phase II human clinical trials are now underway at The University of Texas M.D. Anderson Cancer Center in Houston and several other cancer treatment centers across the USA for prevention and treatment of diarrhea associated with metastatic colorectal cancer patients receiving Irinotecan®.
Salient’s expectation is that the prevention and/or treatment of cancer therapy-induced diarrhea will be the first clinical use for its novel product. Currently, most drugs on the market only treat specific diarrhea-related conditions. We expect CASAD™ to be a more widely applicable platform drug with potential use in inflammatory bowel diseases, infectious disease and radiation-related injury.
Salient has a very active drug development timeline. In addition to the Phase II human clinical trial underway nationally at MD Anderson Cancer Center and other oncology clinics, the company has conducted significant preclinical work in other potential disease areas.
Salient has completed in vitro studies at Texas A&M University demonstrating the ability of its proprietary composition to bind with Clostridium difficile toxins A and B. Our team is now participating in a proof-of-concept human study to demonstrate the same binding in humans and provide initial information about potential efficacy in treating this important disease.
In 2010 and 2011, Salient also conducted two preclinical in vivo studies initially demonstrating the potential of CASAD™ in controlling inflammatory bowel disease. In both studies, CASAD™ showed strong signals of efficacy in colitis models.
In 2011, Salient also explored the development of mouth rinse and enema formulations in preclinical in vivo studies of oral mucositis and radiation proctitis, respectively. As in the colitis studies, CASAD™ showed strong signals of efficacy.
Each of Salient’s target markets —cancer therapy, infectious disease and autoimmune diseases—is large markets with unmet clinical needs.
Overall, the market for anti-diarrhea products was projected to exceed $7 billion in 2011. And while current drugs treat diarrhea case-by-case, Salient’s compound is being developed as a single platform drug with a wide application across all diagnoses, both as a preventative measure and for treatment purposes.