From Trials to Treatment

Overview

The starting material for Salient’s product is a unique, well-characterized inorganic mineral proven to adsorb toxins and inflammatory proteins commonly associated with diarrhea. This mineral has been designated by the FDA as a Generally Recognized as Safe (GRAS) substance.

This mineral’s safety has been proven 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 U.S. for prevention and treatment of diarrhea associated with metastatic colorectal cancer patients receiving Irinotecan®.

It is Salient’s plan to make this product the first diarrhea preventive drug. Whereas most drugs currently on the market only treat specific conditions, we expect our product to be a more widely applicable platform drug.

Product Pipeline

Salient has a very active drug development effort underway. In addition to the Phase II human clinical trial led by MD Anderson Cancer Center and underway nationally at other oncology clinics, the company is in the planning stages for two additional indications.

Salient recently 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 in the planning stages for 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. The target date for launching this study is early 2010.

In 2010, Salient also plans to conduct studies initially demonstrating CASAD’s potential for controlling inflammatory bowel disease.

• CTID
• C. difficile
• Inflammatory Bowel Disease

Market Outlook

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 is projected to exceed $7 billion in 2010. 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.