The US FDA has accepted an amended investigational new drug application for the production and distribution of Radiopharm Theranostics' 68Ga-Trivehexin (RAD 301).
The company said the New York State Board of Pharmacy has also approved its distribution across the state.
It said the upcoming Phase 1 study will evaluate RAD 301 for the detection of lesions in patients with Pancreatic Ductal Adenocarcinoma (PDAC). RAD 301 is a peptide-based molecule that targets αvβ6-integrin, a cellular marker for tumour invasion and metastatic growth, the expression of which correlates with decreased survival in several carcinomas.
The αvβ6-integrin receptor is found in high density on most pancreatic carcinoma cells, making it an attractive diagnostic and therapeutic target. The study will be conducted at the Montefiore Medical Center, Albert Einstein College of Medicine, Nea York, and patient screening is expected to start next week.
“We are very pleased that we now have the green light to start our Phase I imaging trial of RAD 301 in patients with pancreatic cancer, one of the highest areas of unmet medical need,” said Riccardo Canevari, the CEO and managing director of Radiopharm Theranostics. “The team at the Montefiore Medical Center in NYC is excited and fully committed to conducting this very important clinical trial. Radiopharm Theranostics’s team is equally motivated for a successful and fast execution of this Phase I study.”