BioTime, Inc. (NYSE MKT: BTX) and its subsidiary OncoCyte Corporation today announced that OncoCyte has expanded the clinical development of its urine-based bladder cancer diagnostic test by initiating a multi-site clinical trial. The trial, which will involve up to 1,200 patient samples obtained from at least four large urology clinics located throughout the United States, has received Institutional Review Board (IRB) approval at multiple sites and should begin enrolling patients within the next week.
OncoCyte’s initial clinical study of its bladder cancer diagnostic test began in January and involves pathology specimens being collected at a leading medical institution with an international reputation for excellence and discovery. The multi-site clinical trial, which has been initiated in part due to positive interim data from the ongoing study in pathology specimens, is designed to expand the potential use of the PanC-Dx ™ bladder cancer test beyond pathology laboratories and into urologic practices at the point of cystoscopy. Cystoscopy along with urine cytopathology, are the standard methods utilized for bladder cancer screening and diagnosis. The multi-site clinical trial should be completed within 12 months.
The goal of the current clinical trial is to compare the performance of OncoCyte’s proprietary PanC-Dx ™ bladder cancer markers to the performance of cystoscopy. Investigators in the trial are collecting urine samples from patients undergoing cystoscopy for the diagnosis of either primary or recurrent bladder cancer. Cystoscopy and biopsy results will be compared with the results of OncoCyte’s proprietary diagnostic test panel in determining the overall performance of the PanC-Dx ™ markers. PanC-Dx™ is a class of non-invasive cancer diagnostics based on OncoCyte’s proprietary set of cancer markers discovered by OncoCyte scientists through an analysis of broad gene expression patterns in numerous cancer types. The performance of the test in detecting the absence, presence, or progression of urothelial carcinoma in patients will determine the specific nature of the bladder cancer diagnostic to be developed and the regulatory approval pathway that OncoCyte will pursue.
“A urine-based test that accurately discriminates between cancer and benign disease would be of great value. I look forward to working with OncoCyte in helping to develop such a test,” said Neal Shore, M.D., Study Investigator and Medical Director of the Carolina Urologic Research Center (CURC), an independent research arm of Atlantic Urology Clinics in Myrtle Beach, South Carolina. Under the direction of Dr. Shore, CURC conducts phase I - IV drug, biotechnology and device trials focusing on urological diseases. CURC has been recognized both nationally and internationally as one of the most progressive, well-organized, and respected clinical research sites in the United States.
Urothelial carcinoma (UC) constitutes more than 90% of bladder cancers in the Americas, Europe and Asia. Although most patients with bladder cancer can be treated with organ-sparing chemotherapy, UC has a relapse rate of nearly 70% and can progress to invasive, metastatic, and lethal disease. The regular surveillance and treatment of recurrent disease from the time of diagnosis for the remainder of a patient’s life makes UC the most costly malignancy on a per patient basis. The problem is amplified because the two standard methods for surveillance - microscopic assessment of urinary cytology specimens and bladder cystoscopy– possess significant limitations with respect to both performance and cost. Although urine cytology does have a very high positive predictive value (low false positive rate), it has a low negative predictive value and a high indeterminate rate. Patients who have indeterminate urine cytology results commonly undergo cystoscopy, which is painful, time consuming, costly, and unnecessary in many cases since a neoplasm is often not present. In UC, as in virtually all other cancers, earlier and more accurate diagnosis, including diagnosis of disease recurrence, is generally associated with better outcomes and lower cost.
Overall markets for bladder cancer diagnostics are large and growing. Based on National Cancer Institute statistics released in 2012, it was estimated that in 2013 over 72,000 new cases of bladder cancer would occur in the United States and a total of over 550,000 men and women alive would have a history of bladder cancer and be subject to recurrence surveillance testing using cystoscopy or urine cytology. Given this large and growing clinical population, as well as the limitations of current diagnostic methods, a non-invasive and effective bladder cancer screening test could have a significant market opportunity.
“High performing, non-invasive cancer screening diagnostic tests have multiple potential users. In the case of our urine-based bladder cancer diagnostic, we believe urologists and pathologists would be the major adopters of the test. In order to gain test adoption, we believe it is critical to not only generate valid clinical performance data, but also to integrate each user group into clinical trials so specific user needs can be engineered into the ultimate product. The first clinical study of our bladder cancer diagnostic that started earlier this year focused on integrating the needs of the pathologist into the test. This second study now aims to integrate the needs of the urology community into the test. We believe this strategy will result in a product that will be rapidly adopted as it will fit unmet, real-world clinical needs,” said Joseph Wagner, PhD, OncoCyte’s Chief Executive Officer.