The prostate cancer study that is being undertaken by the US-based molecular diagnostics company Chronix Biomedical, has been open for several months and is collecting blood samples from 1,500 men who have been referred for a prostate biopsy following an abnormal PSA test or after a digital rectal examination.
Chronix Biomedical has recently obtained approval from the UK NHS Health Research Authority. Enrolment is well underway with around one fifth of patients recruited to date from centres in the US, the UK and Sweden. The study is expected to complete its patient accrual in mid-2017 and announce results in early 2018.
In a previous retrospective study over 200 patients, Chronix and its collaborators showed that CNI score could be used to discriminate between prostate cancer and non-cancer controls with a diagnostic accuracy of 83%. The CNI score could also be used to distinguish BPH and prostatitis from prostate cancer with a diagnostic accuracy of 90%.
The current study will examine the correlation between the CNI and the tissue diagnosis of prostate cancer. It will also examine whether CNI can be used to identify benign prostatic hyperplasia (BPH).
Chronix also reports that a study is now underway to evaluate Chronix’s Delta Dot therapeutic monitoring test for predicting response to first-line gemcitabine or Folfirinox7 chemotherapy for metastatic pancreatic cancer. This single-arm study in 100 patients will evaluate CNI scores prior to the start of treatment and after the first, second and fourth cycles of chemotherapy. It will compare the performance of the CNI as a therapeutic monitoring test with CA19-9, a marker currently used for predicting response to chemotherapy in this tumour type.
Chronix Biomedical’s CEO, Dr Howard B. Urnovitz, commented:
“We are pleased to update shareholders with the progress we have made with study planning and initiations this year, particularly since our presentations of data at AACR and ASCO. We expect to initiate further studies in due course and intend to report regularly on our clinical progress.”