Radiopharm Theranostics says it has dosed its first pancreatic cancer patient in the initial phase of a study aimed at providing doctors with an enhanced screening process for the lethal and aggressive disease.
The clinical trial in the United States is for the company’s patented “RAD301” radiopharmaceutical technology that is designed to detect lesions in patients with pancreatic ductal adenocarcinoma (PDAC) and create better health outcomes.
The treatment is being developed to bind to a specific cellular marker commonly found in cancer and the company believes it could also help with early detection. The marker is found in high density on most pancreatic carcinoma cells, which management says makes it an attractive diagnostic and therapeutic target.
The study is being conducted at the Montefiore Medical Center in New York’s Albert Einstein College of Medicine and will assess the safety, radiation dosimetry and imaging characteristics of RAD 301 in nine patients.
In October last year, the US Food and Drug Administration accepted Radiopharm’s revised investigational new drug (IND) application, allowing it to kick off the imaging trials. According to recent studies, 99 patients have previously been imaged with RAD301 under compassionate use or as part of an investigator-initiated study, with no arising safety issues reported.
Radiopharm Theranostics managing director and chief executive officer 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.”
The USFDA also recently granted the company an orphan drug designation for RAD 301 and its “trivehexin” treatment, highlighting the significant demand for effective imaging agents for improved and earlier diagnosis of pancreatic cancer. Orphan drug designation recipients receive benefits and incentives including tax credits for qualified clinical trials, exemption from user fees and a potential seven years of market exclusivity following the drug’s approval.
The orphan status can be granted by the USFDA for a drug or biologic product with the potential to diagnose, prevent or treat rare diseases and conditions.
PDAC is considered one of the world’s most lethal and aggressive diseases, with an average five-year survival rate of less than 10 per cent. Traditional treatments such as chemotherapy, surgery and radiation have not been shown to significantly improve survival rates.
RAD301 is one of a swag of cancer diagnostic and therapeutic developments in Radiopharm’s arsenal that could prove game-changers in treating many forms of the disease.
Shares in the company surged more than 21 per cent today on the back of the latest announcement to touch 6.8c during intraday trading from a previous close of 5.6c.
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By Michael Philipps
