GTS Biotech Receives Rare Pediatric Disease Designation from the FDA for CTB-1

GTS Biotech announced today that the U.S. Food & Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation to CTB-1 as an investigational drug candidate for pediatric patients with Osteosarcoma.

“Pediatric patients who develop Osteosarcoma face a significant challenge because of the limited treatment options currently available and the sensitive characteristics that need to be considered during their treatment” said Dr. Sachin Shah, Chief Science Officer. “The Rare Pediatric Disease Designation shows how serious and life-threatening this rare disease affects the pediatric population and supports our mission to provide CTB-1 as a potential new treatment option for patients suffering from Osteosarcoma.”

The RPD program encourages the development of new drugs for the treatment of rare pediatric diseases. RPD Designation is granted by the FDA for serious or life-threatening diseases which affect fewer than 200,000 people in the United States and individuals under 18 years of age. If CTB-1 is approved for the treatment of Osteosarcoma by the FDA, GTS Biotech may be eligible to receive a Priority Review Voucher (PRV) that could be redeemed to receive a priority review for any subsequent marketing application.

CTB-1 has also previously been granted Orphan Drug Designation by the FDA for the treatment of Osteosarcoma. 

About CTB-1 

Cinnamtannin B-1 (CTB-1) is a natural trimeric proanthocyanidin typically derived from plants such as Cinnamomum zeylanicum and Laurus nobilis. CTB-1 has shown anti-proliferative effects against OS cells while having minimal effects on growth of normal osteoblast cells required for bone homeostasis. CTB-1 inhibits the proliferation, migration, and invasion of osteosarcoma by working on the miR-1281/PPIF pathway via upregulation of miR-1281 and downregulates PPIF expression leading to increased levels of apoptosis. CTB-1 has also demonstrated capability for PD-L1 inhibition and enhanced PD-1 expression through p53 stabilization. Due to these mechanisms, OS cell growth and invasion can be inhibited

About GTS Biotech, LLC 

We are a forward-thinking biotech company dedicated to revolutionizing cancer and immunology treatment through the discovery and development of compounds derived from natural sources. We firmly believe that the answers to many of today's medical challenges lie in the world around us. Harnessing the potential of natural compounds, we strive to unlock new frontiers in oncology, immunology and other areas of research to offer hope to patients fighting against cancer. 

For more information, please visit www.gtsbiotech.com