Radiopharm Theranostics Ltd (ASX:RAD, OTC:RDPTF) has officially begun dosing patients for a Phase 1 clinical study assessing the diagnostic potential of radiopharmaceutical 68Ga-Trivehexin (RAD 301) targeting the αvβ6 integrin, for the detection of lesions in patients with Pancreatic Ductal Adenocarcinoma (PDAC).
In May last year the FDA granted Radiopharm an Orphan Drug Designation (ODD) for RAD 301 in pancreatic cancer.
ODD status is given to drugs which show promise in the treatment, prevention or diagnosis of orphan diseases, which are defined as a rare disease or condition that affects fewer than 200,000 people in the US.
Addressing major healthcare challenge
“We are very excited by the progress being made on our RAD 301 clinical program with the dosing of the first participant in this imaging study,” Radiopharm Theranostics CEO and managing director Riccardo Canevari said.
“Current imaging standards of care for the detection of Pancreatic Ductal Adenocarcinoma (PDAC) have significant limitations, making it one of the highest areas of unmet medical need.
“As such, it poses a major challenge for healthcare providers imaging PDAC patients.
“We are delighted to take one major step forward in potentially providing all patients with cancers expressing αvβ6-integrin an alternative and much-needed imaging option.”
The Phase 1 study is being conducted at the Montefiore Medical Center, Albert Eistein College of Medicine, NY, USA, assessing the safety, radiation dosimetry and imaging characteristics of RAD 301 in patients with advanced PDAC.