FDA green light for diagnostic Phase 1 pancreatic trial
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
17 OCTOBER 2023
FDA green light for Trivehexin diagnostic Phase 1
pancreatic clinical trial
•
• Phase 1 patient screening starting next week
• First patient dosing expected by end October
• Study to be conducted at Albert Einstein College of Medicine in New York
• Drug target, avB6, is found on most pancreatic cancer cells
99 patients already received Trivehexin under compassionate use or Investigation Initiated
trial
Sydney, Australia – 17 October 2023 – Radiopharm Theranostics (ASX:RAD), a developer of a worldclass platform of radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased
to announce that the FDA (Food and Drug Administration) has accepted an amended IND for the
production and distribution of 68Ga-Trivehexin (RAD 301) in New York City, USA.
The New York State Board of Pharmacy has also approved its distribution across the State. The
upcoming Phase I study will evaluate 68Ga-Trivehexin (RAD 301) for the detection of lesions in
patients with Pancreatic Ductal Adenocarcinoma (PDAC). Trivehexin is a peptide-based molecule
that targets αvβ6-integrin, a cellular marker for tumour invasion and metastatic growth, the
expression of which correlates with decreased survival in several carcinomas.
The αvβ6-integrin receptor is found in high density on most pancreatic carcinoma cells, making it an
attractive diagnostic and therapeutic target. The study will be conducted at the Montefiore Medical
Center, Albert Eistein College of Medicine, NY, and patient screening is expected to start next week.
“We are very pleased that we now have the green light to start our Phase I imaging trial of RAD 301
in patients with pancreatic cancer, one of the highest areas of unmet medical need,” said Riccardo
Canevari, CEO and Managing Director of Radiopharm Theranostics. “The team at the Montefiore
Medical Center in NYC is excited and fully committed to conducting this very important clinical trial.
Radiopharm Theranostics’s team is equally motivated for a successful and fast execution of this
Phase I study.”
Authorised on behalf of the Radiopharm Theranostics board of directors by Executive Chairman
Paul Hopper.
For more information:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
ASX ANNOUNCEMENT
17 OCTOBER 2023
Timothy McCarthy
Investor Relations
LifeSci Advisors, LLC
P: +1 917 679 9282
E: tim@lifesciadvisors.com
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
Twitter – https://twitter.com/TeamRadiopharm
Linked In – https://www.linkedin.com/company/radiopharm-theranostics/
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
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