Radiopharm Theranostics doses first patient in RAD 301 pancreatic cancer study

Biotechnology company Radiopharm Theranostics (ASX: RAD) has dosed the first patient in a Phase 1 study assessing the safety, dosimetry and imaging characteristics of the RAD 301 isotope in the treatment of advanced pancreatic cancer.

The patient was dosed with 68Ga-Trivehexin (RAD 301) to target the αvβ6 integrin in the detection of lesions relating to pancreatic ductal adenocarcinoma (PDAC).

The αvβ6-integrin is a cellular marker for tumour invasion and metastatic growth, the expression of which correlates with decreased survival in several carcinomas.

The receptor is found in high density on most pancreatic carcinoma cells and is believed to be an “attractive” diagnostic and therapeutic target.

A total of 99 patients have previously been imaged with RAD 301 under compassionate use or as part of an investigator-initiated study, with no adverse safety issues reported.

Major step forward

Managing director Riccardo Canevari said today’s news was considered to be a significant milestone for Radiopharm.

“Current imaging standards of care for the detection of 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 when imaging PDAC patients,” he said.

“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.”

Orphan drug designation

In May, Radiopharm was granted an orphan drug designation by the US Food and Drug Administration for RAD 301 in the treatment of pancreatic cancer.

The decision was believed to have highlighted a significant demand for effective imaging agents to enable earlier diagnosis of the cancer, which has one of the highest levels of unmet needs among all cancer types.

Radiation therapy

Radiopharmaceuticals deliver small doses of radiation to targeted cells for therapeutic or diagnostic purposes.

Mr Canevari said they are fast becoming a “highly-promising” therapeutic frontier in oncology.

“Radiopharmaceuticals offer new hope to patients who may have exhausted all other treatment options,” he said.