RIVIERA BEACH, Fla., July 26, 2017 /PRNewswire/ -- Sancilio Pharmaceuticals Company, Inc. (SPCI) today announced the completion of enrollment of our clinical trial evaluating AltemiaTM, an oral therapy for pediatric patients with Sickle Cell Anemia (SCA) and Sickle Cell Disease (SCD). The SCOT Trial, is a double-blind, placebo-controlled, dose-finding, multi-center study to evaluate the efficacy and safety of AltemiaTM in pediatric patients aged 5-17 years old. This trial is conducted under US IND 125274.
"The completion of enrollment in this study represents an important milestone for SPCI and our lead program for SCA and SCD," said Dr. Fred Sancilio, President and Chief Executive Officer of SPCI. "We are very encouraged by the high retention rate and adherence to treatment seen thus far in the study. This study will further our understanding of the impact of AltemiaTM on Sickle Cell Disease."
Adrian L. Rabinowicz, M.D, SPCI's Chief Medical Officer, stated, "The faster than expected enrollment in this study highlights the intense interest and enthusiasm of the investigators, their staffs, as well as the patients and their families in achieving this important step for our development program. We look forward to reporting top-line results from the study early Q4 this year."
Sickle Cell Disease (SCD) and Sickle Cell Anemia (SCA) are a group of genetic disorders that result in dysfunctional hemoglobin and a depletion of certain fatty acids in the membrane of red and white blood cells. These abnormalities increase the red and white blood cells tendency to adhere to each other, which results in episodic occlusions of blood vessels, reperfusion damage, and excruciating pain. Ultimately, many children develop end organ damage and strokes. There are approximately 100,000 cases of SCD in the United States and millions outside of the United States. Treatment options are limited.
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. More information is available at Sancilio.com.
Contacts Sancilio Pharmaceuticals Company, Inc. Marc Wolff, 561-847-2302 Executive Vice President & Chief Financial Officer