Full Press Release Details
Inc. Subsidiary OncoCyte Corporation Expands Clinical Development of
Bladder Cancer Diagnostic by Initiating a Large Multi-Site Clinical Trial
to be Tested on Over 1,000 Patient Samples from Urology Clinics Located
Throughout United States-
ALAMEDA, Calif.--(BUSINESS WIRE)--July 31, 2014--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
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
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
"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.
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About OncoCyte Corporation
OncoCyte, a majority-owned subsidiary of BioTime, Inc., is developing
novel products for the diagnosis and treatment of cancer in order to
improve the quality and length of life of cancer patients. Based on
large unmet need, market size, and data generated thus far from patient
sample screening, OncoCyte is initially focusing its efforts on
developing PanC-Dx diagnostic products for use in detecting
breast, bladder, and lung cancers. PanC-Dx is a class of
non-invasive cancer diagnostics based on a proprietary set of cancer