FDA Grants Orphan Drug Designation For TP-317 To Treat Pancreatic Cancer

Release Date: 10-Sep-2021

Thetis Pharmaceuticals receives orphan drug designation (ODD) from US FD to TP-317 for the treatment of Pancreatic Cancer. Pancreatic cancer is a lethal disease that accounts for 3.2% of cancer cases in the U.S. (57,600 in 2020) but contributes to 8% of cancer deaths (47,050 in 2020), making it the fourth leading cause of cancer-related mortality in the US. By 2030, pancreatic cancer is expected to become the second leading cause of cancer death in Western countries.


TP-317 is a patent-protected new molecular entity that delivers Resolvin E1 (RvE1), a naturally-occurring lipid mediator discovered by biomedical researchers. Investigation from the Panigrahy Lab published in the Journal of Experimental Medicine shows that Resolvins suppress tumor growth by reprogramming the tumor microenvironment to clear tumor cell debris and decrease secretion of pro-tumor cytokines. Recent preclinical studies conducted at the Panigrahy Lab shows that TP-317 has additive effects with chemotherapy and immunotherapy in pancreatic cancer models.

Need custom market research solution? We can help you with that too.