Radiopharm Theranostics (ASX: RAD) gets FDA approval for Trivehexin Phase 1 trial

October 17, 2023 01:01 PM AEDT | By Sonal Goyal

Radiopharm Theranostics (ASX: RAD) gets FDA approval for Trivehexin Phase 1 trial — Image source: Company website

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Highlights

The FDA and the New York State Board of Pharmacy have provided approvals for the distribution of RAD 301 in New York City.

FDA has granted permission to conduct a Phase 1 clinical trial for Trivehexin diagnostic in patients with pancreatic cancer.

Phase 1 patient screening is expected to commence next week.

Radiopharm Theranostics Limited (ASX: RAD) has shared an upbeat update, announcing approval from the US Food and Drug Administration (FDA) to commence Phase I pancreatic clinical trial of 68Ga-Trivehexin (RAD 301). The FDA has accepted an amended IND, which allows the company to produce and distribute RAD 301 in New York City, the US.

The company informed that the New York Board of Pharmacy has also given green light for the distribution of RAD 301 across the state.

Data source: Company update

About the Phase1 pancreatic clinical trial

The study will examine 68Ga-Trivehexin (RAD 301) to identify lesions in Pancreatic Ductal Adenocarcinoma (PDAC) patients.

Data source: Company update

The study will be conducted at Albert Einstein College of Medicine in New York. Phase I patient screening is expected to commence in the upcoming week, with the first patient dosing targeted by the end of this month.

The company informed that as part of the compassionate use or investigation initiated trial, 99 patients have received the RAD 301 drug.

RAD shares traded at AU$0.130 at the time of writing on 17 October 2023.

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