The U.S. Food and Drug Administration (FDA) recently granted the orphan drug designation to rucosopasem manganese, a pancreatic cancer treatment developed by Malvern-based Galera Therapeutics, a clinical-stage biopharmaceutical company.
The orphan drug designation is granted to a drug product intended to treat, diagnose or prevent a rare disease or condition. Receiving the designation provides companies market exclusivity upon regulatory approval, exemption from FDA application fees, and tax credits for qualified clinical trials.
The FDA defines a rare disease as a condition with a prevalence of less than 200,000 in the United Status.
“Orphan drug designation for rucosopasem highlights the urgent need for more treatment options to extend survival in patients with pancreatic cancer, which is the fourth leading cause of cancer death in the U.S.,” Dr. Mel Sorensen, Galera president and CEO, said. “We believe rucosopasem has the potential to improve the efficacy of SBRT for pancreatic cancer, and we anticipate topline data from GRECO-2 by the end of next year.”
Rucosopasem is in clinical development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with pancreatic cancer and lung cancer.
Galera is conducting the GRECO-2 Phase 2b randomized, double-blind, placebo-controlled trial of rucosopasem in combination with SBRT in 220 patients with locally advanced pancreatic cancer.