Check-Cap, a clinical stage medical diagnostics company advancing the development of the C-Scan System the first and only preparation-free ingestible scanning capsule based system for the prevention of colorectal cancer through the detection of precancerous polyps, has announced positive results from its pilot study of the C-Scan System in the US.
The prospective, multi-centre, open label, single arm study was designed to evaluate the safety, usability and subject compliance of the C-Scan System. The study included 28 evaluable patients, more than two thirds of whom were considered to be of average risk for colorectal cancer. Each patient ingested a C-Scan capsule and also underwent a faecal immunochemical test (FIT) as well as a comparative colonoscopy, which was performed by an independent gastroenterologist who was blinded to the corresponding test results.
"The results of the study are promising, both in terms of safety and patient compliance of the procedure," said Dr Seth A Gross, principal investigator of the study, gastroenterologist and associate professor of medicine at NYU Langone Health. "Most non-invasive colorectal cancer screening options currently available have modest efficacy detecting pre-cancerous polyps. We are excited about the potential of the C-Scan System offering a patient-friendly screening option that could detect pre-cancerous polyps before they become malignant, and we look forward to seeing the C-Scan System advancing into the US pivotal study in the future."
The study was performed at two sites, the NYU Grossman School of Medicine and Mayo Clinic, Rochester. The primary endpoint of the study was to evaluate the incidence of device or procedure related serious adverse events. Secondary endpoints included patient compliance, subject satisfaction and device and procedure related performance. Due to sample size, the study was not designed to be powered for statistical significance.
Dr Elizabeth Rajan, principal investigator of the study, gastroenterologist and professor of medicine, Mayo Clinic, Rochester stated, "The availability of preparation-free options for colorectal cancer screening are appealing to patients and may indeed increase screening rates. Initial results from the pilot study are promising with a US pivotal study planned for 2020".
No device or procedure related serious adverse events (SAEs) were reported and all device or procedure related adverse events were mild in severity. In total, 45 patients enrolled in the study, of which 40 patients underwent the study procedure. All 40 patients complied with the procedure and completed a questionnaire following the procedure and reported higher satisfaction with the C-Scan System procedure compared to colonoscopy. A total of 28 patients were evaluable after factoring in technical and physiological dropouts and protocol violations. Analysis of the evaluable patient results revealed agreement between C-Scan and colonoscopy in detection of polyps was consistent with data from the post-CE approval study.
"We are pleased with the positive results from this U.S. pilot study. Completing our first study in the US constitutes an important milestone for our company as we work towards the initiation of a US pivotal study in late 2020,” said Alex Ovadia, chief executive officer of Check-Cap. “We are now focused on preparing our IDE submission to the FDA and collecting additional clinical data utilising a new version of our C-Scan System, while at the same time continuing to build out our global operational infrastructure. We believe 2020 will be a meaningful year for Check-Cap."