SM08502 Receives Orphan Drug Designation for Pancreatic Cancer

Data from Phase 1 Study Expected by Summer of 2019

SM08502 (Samumed) has received orphan drug status for the treatment of pancreatic cancer. The oral small-molecule Wnt pathway inhibitor may potentially reduce the expression of genes controlling the differentiation and multiplication of tumor cells.

The drug is currently being evaluated in an open-label, multicenter, dose-escalation phase 1 study (NCT03355066) in 42 adult patients with advanced solid tumors for whom standard therapy is not available. The study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered SM08502 once daily for 28 consecutive days for up to six cycles.

Pancreatic cancer is the fourth leading cause of cancer death in men and women.  Symptoms usually appear during the cancer’s later stages, which contributes to the high mortality rate. In 2018, approximately 55,440 new cases of pancreatic cancer were diagnosed in the U.S. representing 3.2% of all new cancer cases. Around 44,330 deaths from the illness occurred in the same year.

Sources: MPR, January 3, 2019; GlobeNewswire, January 3, 2019