The Food and Drug Administration (FDA) has greenlit an investigational new drug (IND) amendment for Radiopharm Theranostics Ltd (ASX:RAD)’s production and distribution of 68Ga-Trivehexin (RAD 301) in New York City, USA.
Phase 1 patient screening for the Trivehexin diagnostic Phase 1 pancreatic clinical trial will begin next week, with the first patient expected to be dosed by the end of October.
Trivehexin, a peptide-based molecule, specifically targets αvβ6-integrin—a cellular marker associated with tumour invasion and metastasis, which is densely present in most pancreatic carcinoma cells.
Notably, 99 patients have already received Trivehexin under compassionate use or Investigation Initiated trial.
Focused on detecting lesions
The New York State Board of Pharmacy has granted approval for statewide distribution of 68Ga-Trivehexin (RAD 301), setting the stage for the imminent Phase 1 study focused on detecting lesions in patients with Pancreatic Ductal Adenocarcinoma (PDAC).
The study is set to be hosted by the Montefiore Medical Center and Albert Einstein College of Medicine in New York.
“We are very pleased that we now have the green light to start our Phase 1 imaging trial of RAD 301 in patients with pancreatic cancer, one of the highest areas of unmet medical need,” RAD CEO and MD Riccardo Canevari said.
“The team at the Montefiore Medical Center in NYC is excited and fully committed to conducting this very important clinical trial. Radiopharm Theranostics’ team is equally motivated for a successful and fast execution of this Phase 1 study.”
Radiopharm is a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses.