ImPact Biotech, the IMmune Photo Activated Cancer Treatment (IMPACT) specialist announces the U.S. Food and Drug Administration granted Orphan Drug Designation (ODD) to Padeliporfin Vascular Targeted Photodynamic therapy (VTP) for the treatment of patients with locally advanced pancreatic Cancer.
The Investigational New Drug (IND) application, allowing initiation of the Phase 1 clinical trial of Padeliporfin VTP in patients with locally advanced pancreatic ductal adenocarcinoma, will be submitted later this year and is expected to begin enrollment this year. Padeliporfin VTP has also previously received Fast Track designation and Orphan Drug Designation from the FDA for the treatment of adult patients with low-grade UTUC.
Orphan drug status confers a number of advantages for product development, including a tax credit for the cost of clinical trials undertaken in the US, marketing exclusivity for seven years, written recommendations from the FDA on clinical and preclinical studies needed for approval and a fast-track procedure for regulatory review.
Barak Palatchi, CEO of ImPact Biotech, said,
