- OncoSil Medical (OSL) enrols the first patient into its randomised clinical study of its namesake OncoSil device to be used in combination with Folfirinox chemotherapy
- OSL plans to recruit 80 patients across 15 hospital sites in the UK and the European Union under the pancreatic cancer treatment trial
- The first patient has been enrolled in Navarre, Spain, and another four sites have been initiated to screen patients in key treatment centres across Belgium and Spain
- Through the study, OSL aims to expand the CE Marking approval of the OncoSil device in the UK and the European Union for patients treated with gemcitabine-based or FOLFIRINOX chemo
- OSL shares are down 4.55 per cent and trading at one cent at 12:59 pm AEST
OncoSil Medical (OSL) has enrolled the first patient into its randomised clinical study of its namesake OncoSil device to be used in combination with Folfirinox (FFX) chemotherapy.
The study will compare the use of the company’s targeted intratumoral placement of phosphorous-32 (TRIPP) product in addition to FFX with the use of FFX chemo alone in patients with pancreatic cancer.
OSL’s lead product is a targeted radioactive isotope that can be implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.
The treatment is intended to deliver more concentrated and localised beta radiation compared to external beam radiation, and six previous clinical studies have produced positive results on tolerability, safety, and efficacy.
OSL expects to recruit 80 patients under its new trial across 15 hospital sites in the UK and the European Union.
Four sites have been initiated and are currently screening patients for the study in
key treatment centres across Belgium and Spain, with the first patient enrolled in Navarre, Spain.
“The study represents an important milestone in the evolution of the OncoSil device as it serves to open the indication, thereby making it accessible to a larger patient population diagnosed with LAPC,” OSL CEO and Managing Director Nigel Lange said.
“We look forward to further study sites opening up to recruitment.”
OSL said through the study, it aimed to expand the CE Marking approval of the OncoSil device in the UK and the European Union for patients treated with gemcitabine-based or Folfirinox chemo.
The primary endpoints of the OncoSil clinical trial include safety and tolerability and local disease control rates at the 16-week mark.
Secondary endpoints will also be included in the study, such as overall survival (OS), quality of life, pain scores, tumour response, and surgical resection rates.
OSL shares were down 4.55 per cent and trading at one cent at 12:59 pm AEST.