The US FDA Clears ImPact Biotech’s IND Application for Padeliporfin VTP to Initiate P-I Trial for Pancreatic Cancer
Shots:
- The US FDA has cleared the IND application submitted by ImPact Biotech for Padeliporfin VTP to initiate clinical evaluations for the treatment of patients with unresectable pancreatic adenocarcinoma (PDAC). The trial is expected to commence by H1’24
- The P-I clinical trial is expected to evaluate the safety, tolerability PK, PD & preliminary efficacy of Padeliporfin VTP therapy in patients with Stage 3 locally advanced and unresectable PDAC
- The study will be conducted in 2 parts in which Part A will use a 3+3 dose-escalation design to evaluate the safety & tolerability of Padeliporfin VTP, while Part B will enroll an expansion cohort to evaluate its efficacy
Ref: Globe Newswire | Image: ImPact Biotech
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
