BioTime, Inc. Subsidiary OncoCyte Corporation Completes Initial Enrollment of Clinical Study of Urine-Based Bladder Cancer Diagnostic

BioTime, Inc. (NYSE MKT:

) and its subsidiary OncoCyte Corporation today announced that OncoCyte has completed enrollment in the initial clinical study of its urine-based bladder cancer diagnostic test. The study, which involved 100 patients, was conducted in collaboration with investigators in the Department of Pathology, Division of Cytopathology, at a leading medical institution with an international reputation for excellence and discovery. Initial results of the study have been submitted for presentation at a large upcoming cancer society meeting; eventual publication of the final results in a peer-reviewed clinical journal is also anticipated. The goal of this clinical study was to assess the performance of OncoCyte's proprietary diagnostic technology in detecting the most common type of bladder cancer; namely, urothelial carcinoma (UC) (previously designated transitional cell carcinoma). Study investigators collected urine samples from patients undergoing urine cytology for the diagnosis of either primary or recurrent bladder cancer. Patient urine samples were assessed microscopically for the presence of cancer cells using the current standard-of-care method of cytopathology; in parallel, OncoCyte scientists analyzed the remaining portion of the urine samples for gene expression, including expression of OncoCyte's proprietary PanC-Dx™ markers. In some cases, the quality of the residual urine sample provided to OncoCyte did not allow for a valid analysis; in these cases additional replacement samples will be provided. A statistical analysis was performed and a panel of markers that discriminates UC from non-cancerous conditions was identified. The ability of the markers tested in the studies to determine the absence, presence, or progression of UC in patients will determine the specific nature of the bladder cancer test to be developed and the regulatory approval pathway that OncoCyte will pursue. “There is a large and growing need for more sensitive, cost-effective, and less invasive methods to detect and monitor cancer in humans, particularly in bladder cancer. The completion of enrollment in this clinical study represents a major milestone in our efforts to develop a urine-based bladder cancer diagnostic. Importantly, the study not only was completed in the projected time frame but also the results to date have exceeded our expectations in terms of our diagnostic test performance. We are currently validating the results of this study in a larger prospective trial that will enroll up to 1400 patients. The larger study was initiated in July and has already enrolled over 300 patients at four sites; we are currently recruiting additional sites and plan on completing the study in 2015,” said Joseph Wagner, PhD, OncoCyte's Chief Executive Officer. 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.