ExThera Medical’s OSCAR I Study (ONCObind CTC Removal Study), aimed at treating Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), has enrolled the first patient at OU Health Stephenson Cancer Center, which is the clinical partner of the University of Oklahoma.
This trial will analyse the initial safety and signals of efficacy by determining the capability of the ONCObind procedure hemoperfusion filter to eliminate circulating tumour cells (CTCs) from the bloodstream of those patients suffering from metastatic pancreatic ductal adenocarcinoma (PDAC).
ExThera Medical CEO Erin Borger said: “The enrolment of the first patient in the OSCAR I STUDY is a significant milestone in our mission to provide innovative treatment options for cancer patients.
“This trial represents the opportunity to offer potential new hope for patients with metastatic PDAC, who currently face limited options and poor prognosis.
An extracorporeal blood filtration procedure intended to target and filter out CTCs from the blood of patients, the ONCObind procedure haemoperfusion filter is the product brand name for the Onco-Seraph platform.
Shed from primary tumours, CTCs lead to metastasis, which causes most deaths associated with cancer.
The ONCObind procedure leverages a blood filter that is based on ExThera's Seraph 100 Microbind Affinity Blood Filter technology. In a recent in vitro study, this technology has shown major success in lowering CTCs.
The OSCAR I Trial, a prospective single-arm feasibility study, is expected to enrol five patients with PDAC. OSCAR I will be followed by the OSCAR II feasibility trial.
The focus of the OSCAR I study will be on pharmacokinetics / pharmacodynamics in the first five patients following which it will be expanded to additional participants.
Patients will get standard-of-care follow-up for up to five years.
This study represents a first step toward FDA approval and commercialisation of this therapy.
ExThera Medical is involved in the development and commercialisation of extracorporeal blood filtration devices, including the Seraph 100 MicroBind Affinity Blood Filter for eliminating a wide range of pathogens from patients’ blood.
Seraph 100 can be used on battlefields, in hospitals, clinics, and other adverse environments to address nosocomial and community-acquired infections.
