RIVIERA BEACH, Fla.--(BUSINESS WIRE)--Sancilio Pharmaceuticals Company, Inc. (SPCI) today announced the start of the first of two placebo controlled clinical trials in US pediatric patients affected with Sickle Cell Disease (SCD). Recruitment in the trial is underway and enrollment is expected to be completed by Q2 2017 and will be immediately followed by a second placebo controlled clinical study in Q3 2017.
SCD is estimated to affect 100,000 Americans, with a disproportional impact on African Americans.
“It has taken us nearly 3 years to get to the point of dosing children in the United States who have this horrible disease. I am excited by the data we’ve seen in studies performed abroad, but having only children from the United States in such a study will be exciting and conclusive,” said Dr. Frederick Sancilio, CEO of SPCI.
About Sancilio Pharmaceuticals Company, Inc.
Sancilio Pharmaceuticals Company, Inc. (SPCI) is a fully integrated, specialty pharmaceutical company focused on developing, manufacturing and commercializing pharmaceutical products, including those based on our proprietary Advanced Lipid Technologies® (ALT®) platform. SPCI is pursuing treatments for sickle cell disease, short bowel syndrome and severe hypertriglyceridemia. We utilize our cGMP compliant facility to develop and manufacture our products. Our ALT® platform is designed to enhance the bioavailability, reduce the food effect and improve the efficacy of lipids and lipophilic active pharmaceutical ingredients (APIs). Lipids are hydrophobic or amphipathic molecules, including fatty acids, steroids (including hormones) and fat-soluble vitamins (such as vitamins A, D, E and K). Our business model is to apply our ALT® platform to lipids or lipophilic APIs to create unique product candidates that address the disorders and diseases resulting from imbalances of lipids in the body. In addition to our primary focus of developing our proprietary products using the ALT® platform, we make use of, and license rights to, our proprietary ALT® platform and other technologies to third parties, providing both development and subsequent soft gelatin encapsulation services as required. More information is available at: www.sancilio.com.