First patient enrolled in the TRIPP-FFX Clinical Study
Sydney, Australia – 3 May 2023: The Board of OncoSil Medical Ltd (ASX: OSL) (OncoSil or the Company), a medical device company focused on treatments for patients with locally advanced pancreatic cancer (LAPC), is pleased to announce that the first patient has been enrolled in the TRIPP-FFX Clinical Study.
The TRIPP-FFX Clinical Study is an open-label, multi-centre, randomized study of TaRgeted Intratumoural Placement of Phosphorous-32 (OncoSilTM) in addition to FOLFIRINOX chemotherapy versus FOLFIRINOX chemotherapy alone in patients with unresectable locally advanced pancreatic cancer. The aim of this Clinical Study is to expand the CE Marking approved use of the OncoSilTM device in the UK and the European Union for patients being treated either with gemcitabine-based chemotherapy or FOLFIRINOX chemotherapy.
The objective of the TRIPP-FFX Clinical Study is to evaluate the safety and efficacy of OncoSilTM in patients with unresectable Locally Advanced Pancreatic Cancer who are treated with FOLFIRINOX chemotherapy.
The primary endpoints of the study include safety and tolerability and Local Disease Control Rate at 16 weeks. Secondary endpoints will also be included in the study, including Overall Survival (OS), quality of life, pain scores, tumour response and surgical resection rates.
The Clinical Study will be conducted in approximately 15 hospital sites in the United Kingdom and the European Union. The total number of patients in the Clinical Study will be 80 patients, randomised on a 1:1 basis for treatment with the OncoSilTM device in addition to chemotherapy versus chemotherapy alone.
A total of four sites have been initiated and are now currently screening patients for the Clinical Study, in key treatment centres in Belgium and Spain.
The first patient has been enrolled in the Clinical Study at the Clínica Universidad de Navarra, Spain.
The Principal Investigator at Clínica Univerisdad de Navarra, Dr Mariano Ponz Sarvisé said:
“I am very pleased that the TRIPP-FFX study now started enrolling patients. The study will provide researchers and physicians important information on the added value of the OncoSilTM device for patients with LAPC, when used in addition to FOLFIRINOX chemotherapy. This is an important step in the search for new efficacious treatments for patients with LAPC with otherwise limited treatment options.”
OncoSil’s CEO and Managing Director, Mr Nigel Lange said:
“We are excited that the TRIPP FFX study has commenced recruitment. The study represents an important milestone in the evolution of the OncoSilTM device as it serves to open the indication thereby making it accessible to a larger patient population diagnosed with LAPC. We look forward to further study sites opening up to recruitment.”