Starpharma Says US FDA Supports First-in-Human Study of Cancer Radiotherapy Candidate; Shares Gain 7%
Starpharma Holdings (ASX:SPL) has received positive feedback from the US Food and Drug Administration (FDA) on the proposed design of its first-in-human phase 1 clinical study of the DEP HER2 radiotherapy candidate, according to a Tuesday filing with the Australian bourse.The company is developing the candidate to treat certain gastric/gastro-oesophageal junction cancers and other advanced cancers in patients who have previously received targeted therapy.The US FDA feedback supports plans to launch the phase one study, which is on track to begin in the second half of the year.The FDA also confirmed that the radiotherapy candidate is targeting a population with a significant unmet medical need, indicating the potential for a fast-track designation or other accelerated development pathways, Starpharma said.The company's shares were 7% higher in recent Tuesday trade.
