Radiopharm Theranostics Ltd (ASX:RAD) has received US Food and Drug Administration (FDA) Investigational New Drug Application (IND) approval for its αVβ6 Integrin (RAD301) technology.
With this approval, RAD can now start a Phase 1 imaging trial in ambulatory patients with pancreatic cancer.
It is aiming to start the trial at the end of the first quarter of 2023 with an estimated close by 2023's third quarter and is now proceeding with clinical site preparation, with the first subject expected to be dosed at Montefiore Einstein Cancer Center (MECC) in New York.
Current imaging options for pancreatic cancer have several limitations, with this form of cancer presenting a high unmet medical need.
RAD301 technology has already generated significant clinical data from 88 patients dosed to date in various geographies that could help address this need.
Proving its aim
Radiopharm Theranostic chief executive officer & managing director Riccardo Canevari said of the IND approval: “We’re looking forward to working further with this peptide to prove its ability to deliver high-quality imaging results in diagnosing pancreatic cancer.
“We’re very confident we can drive the speed of recruitment for the trial and that the technology will generate a positive outcome we can push toward commercialisation.”
Dr Lionel S Zuckier, MD, MBA, principal investigator of this clinical trial, Professor of Radiology and division head of Nuclear Medicine at Albert Einstein College of Medicine at Montefiore Medical Center, and a member of MECC said RAD’s solution was something cancer patients could benefit greatly from.
“Patients with pancreatic cancer have limited therapeutic options, and on top of that face challenges in their initial diagnosis and follow-up. The medical community needs improved imaging agents to facilitate optimised patient diagnosis and management.”
High priority
The MECC has made early-phase clinical trials a high priority in its drive to address the needs of its diverse Bronx community as well as patients with cancer around the nation and the world, said MECC Director Edward Chu, MD, MMS.
“For 50 years, our basic scientists have been making paradigm-shifting discoveries in the laboratory that have laid the groundwork for drug discovery and development and in particular, for translation of these discoveries into early-phase clinical trials.”
Radiopharm Theranostics and TRIMT GmbH entered into an exclusive licence agreement in August 2021 to develop radiopharmaceuticals including Ga68-Integrin (RAD301).