Rigenerand has chosen the Center for Outcomes Research and Clinical Epidemiology (Coresearch) to be the CRO for its Phase I gene therapy trial in pancreatic cancer, scientific founder Dr Massimo Dominici said. The Phase I will likely begin in May 2021, although the exact timing could depend on feedback from the Italian Medicines Agency (AIFA), he added.
Modena, Italy-headquartered Rigenerand chose the Pescara, Italy-based CRO due to its close geographic proximity and previous experience in running gene therapy trials, Dominici explained. In addition to being involved with the clinical trial, the CRO will also be tasked with working and communicating with Italian regulators, he added. Coresearch did not respond to a request for comment.
The Phase I will focus on finding the optimal dose of RR001 and evaluating the treatment’s efficacy profile in pancreatic cancer, Dominici said. The Phase I would be a six-month, dose-escalation trial recruiting nine patients from two trial sites, this publication reported on 7 July. Rigenerand has €80,000–€200,000 ($97,500–$244,000) to retain the Phase I CRO, Dominici previously told this publication.
RR001 is designed to treat solid tumors in cases where chemotherapy and radiotherapy were not effective, according to the company website. Adipose perivascular stromal cells are isolated from the patient via an invasive liposuction procedure. These cells are then engineered in vitro and will secrete soluble tumor necrosis factor-related apoptosis-inducing ligands upon reinfusion to the patient. AIFA authorized Rigenerand to manufacture its gene therapy product and approved the Phase I in June 2020.
William Newton is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.