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- Radiopharm Theranostics (RAD) secures orphan drug designation for its radiopharmaceutical technology to treat pancreatic ductal adenocarcinoma (PDAC)
- The designation follows the FDA’s recent investigational new drug approval (IND) for Radiopharm’s phase one clinical trial in pancreatic cancer
- RAD now holds two FDA orphan drug designations for cancer after it received approval for its antibody to treat patients with osteosarcoma
- The company’s US phase one clinical trial in pancreatic cancer is due to commence in the coming weeks
- RAD shares are trading at 17.5 cents at 11:30 am AEST
Radiopharm Theranostics (RAD) has been granted US FDA orphan drug designation for its radiopharmaceutical technology, Ga68-Trivehexin (RAD 301) to treat pancreatic ductal adenocarcinoma (PDAC).
RAD 301 is a proprietary peptide-based molecule that targets a cellular marker for tumour invasion and metastatic growth, which can potentially reduce survival rates for several carcinomas.
RAD CEO and Managing Director Riccardo Canevari said the designation followed the FDA’s recent investigational new drug approval (IND) for a phase one clinical trial in pancreatic cancer.
“This important designation further reinforces the excitement of investigators conducting the study,” Mr Canevari said.
“The FDA’s decision highlights the significant demand for effective imaging agents for improved and earlier diagnosis of pancreatic cancer, which has one of the highest levels of unmet needs among all cancer types.”
Radiopharm now holds two FDA orphan drug designations for cancer, after the company secured approval for its LRRC15 antibody DUNP19 for treating patients with osteosarcoma.
The company’s phase one clinical trial in pancreatic cancer is due to commence in the next few weeks in the United States.
RAD has signed an exclusive licensing agreement with German-based biotechnology company, TRIMT GmbH, to develop and commercialise RAD 301 in the USA, Australia, China, Hong Kong, and Japan.
RAD shares last traded at 17 cents at 11:30 am AEST.
