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January 27, 2014
09:09 EDTBTXBioTime, unit initiates PanC-Dx clinical development in U.S., China
BioTime and its subsidiary OncoCyte announced that OncoCyte has initiated clinical development of its bladder cancer diagnostic test, PanC-Dx, in both the U.S. and China. In the U.S., OncoCyte has entered into a clinical trial agreement with a leading medical institution with an international reputation for excellence and discovery, while in China, OncoCyte has entered into a fee-for-service agreement with China Medicine. The goal of these clinical studies is the testing of OncoCyte’s proprietary diagnostic technology in the most common type of bladder cancer, namely, urothelial carcinoma. Investigators in the collaborating institutions are collecting urine samples from patients at time of bladder cancer diagnosis as well as from those with a risk for recurrent disease. A statistical analysis of these and other results will be performed to determine the overall relative performance of OncoCyte’s PanC-Dx markers. Completion of these studies is expected by late 2014.
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April 27, 2015
09:26 EDTBTXBioTime clinical-grade hES cell lines to be used in planned CIRM-funded study
BioTime announced that the clinical-grade human Embryonic Stem, or hES, cell lines from BioTime’s wholly-owned subsidiary ES Cell International Pte, will be used by UC Irvine scientist Dr. Leslie Thompson to continue her promising research in the use of stem cells to treat Huntington’s disease under a $5M grant from the California Institute for Regenerative Medicine, or CIRM. The CIRM grant will further support a collaboration between ESI and UC Davis’s good-manufacturing-practice, or GMP, laboratory for the creation of the GMP grade cells needed in Dr. Thompson’s preclinical and potentially subsequent clinical studies. This collaboration is an example of BioTime’s strategy to leverage collaborations and potentially generate future revenues by placing its hES cells in a wide array of medical applications that BioTime could not otherwise address with its own resources. ESI provides its hES cells as both inexpensive research-grade cells through its ESI BIO division and as GMP-compliant clinical grade cells for translation into clinical applications, allowing researchers to conduct research with hES cells that can also be used in the clinic.
April 22, 2015
08:09 EDTBTXBioTime announces nonexclusive license agreement with BRICOH
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April 20, 2015
12:01 EDTBTXOncoCyte announces initial data from ongoing clinical study of PanC-Dx
BioTime and its subsidiary OncoCyte Corporation announced initial data from a large, prospective clinical study that showed the potential of PanC-Dx, OncoCyte’s non-invasive diagnostic technology based on its proprietary set of cancer markers, as a non-invasive, blood-based diagnostic test to screen for multiple types of human cancers, including breast cancer. The early data showed the utility of the protein Collagen Type X in distinguishing patients with malignant breast lesions from those with negative findings. The controlled study, initiated at Scottsdale Medical Imaging Laboratories in Scottsdale, AZ, is ongoing and has nearly completed enrollment of over 600 patients. The goal of this study is to assess the performance of PanC-Dx in discriminating patients with malignant breast lesions from those with negative findings or benign findings. Early data showed that PanC-Dx™ identified a mean concentration of COL10A1 protein in sera of breast cancer patients that was 35% higher than the mean COL10A1 value in sera of normal individuals (n=32). No significant differences were noted when comparing breast cancer patients to patients with confirmed benign disease suggesting that additional biomarkers may be necessary to discriminate these two populations.
06:32 EDTBTXBioTime and its subsidiary announce positive results from PanC-Dx studies
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