BioTime (BTX) Unit Updates on Plans for PanC-Dx Development

January 31, 2013 9:06 AM EST
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BioTime, Inc. (AMEX: BTX) and BioTime’s subsidiary OncoCyte Corporation provided an update on the progress of development of PanC-Dx, a novel blood-based diagnostic test utilizing molecular markers discovered at BioTime and OncoCyte designed to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon. By facilitating early, non-invasive cancer detection, PanC-DxTM could lead to more successful therapeutic outcomes through earlier diagnosis and treatment. This diagnostic test could also reduce the cost of cancer monitoring and increase the availability of affordable cancer screening worldwide. OncoCyte first announced the development of PanC-DxTM during December 2011 and last provided a progress update in March 2012. In addition to this update, OncoCyte intends to release additional information regarding the progress of PanC-DxTM development throughout 2013.

OncoCyte’s plans for 2013 include the initiation of a clinical study focused on breast cancer screening at a group of leading cancer research institutions. OncoCyte has been developing, characterizing, and manufacturing monoclonal antibodies in preparation for the initiation of the clinical study and is currently working with a select group of cancer researchers to design the trial and select the study sites. If its laboratory findings are validated in clinical trials, PanC-DxTM may be used as a simple, routine blood test that could be performed in women of any age at any desired frequency to detect breast cancer with as much if not better accuracy and with less cost than a conventional mammogram.

OncoCyte has achieved several key advances in the past year, including:

* Completion of the development and characterization of over 50 proprietary, patent pending, monoclonal antibodies targeting 7 novel cancer antigens. OncoCyte’s findings show a significant elevation of these antigens in the blood of cancer patients when compared to healthy control patients;
* Initiation of validation studies of ELISA assays in order to demonstrate high-sensitivity detection of target antigens using proprietary monoclonal antibodies;
* Completion of large-scale manufacturing of 11 proprietary monoclonal antibodies;
* Initiation of prototype development for a second detection format (solid phase ELISA point of care testing) through a collaborative development agreement; and
* Initiation of clinical trial protocol design analysis in consultation with key opinion leaders and outside diagnostic experts.

Key goals for 2013 will be:

* Completion of validation of our proprietary ELISAs in our patient sample dataset;
* Formalization of additional relationships with key opinion leaders at major medical institutions;
* Institutional review board (IRB) approval and initiation of a large, prospective multicenter patient study at leading breast cancer institutions;
* Presentation of key findings at major oncology-related scientific conferences; and
* Submission of manuscripts to peer-reviewed scientific journals for publication.

Based on large unmet need, market size, and data generated thus far from patient sera screening, OncoCyte is initially focusing its efforts on biomarkers associated with breast cancer. The apparent high correlation of certain combinations of biomarkers in breast cancer has made this indication an attractive initial target. If clinical trials are successful, OncoCyte intends to launch PanC-DxTM as an in vitro diagnostic (IVD) in Europe, potentially commencing in 2014, before seeking FDA approval required to market PanC-DxTM in the United States. Some CLIA-certified clinical laboratories may choose to offer PanC-DxTM on a limited basis prior to EU and FDA approval.

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