BioTime’s Subsidiary OncoCyte Corporation Provides An Update On The Development Of The Novel Pan-Cancer Diagnostic Product PanC-DxTM

BioTime, Inc. (NYSE MKT: BTX) and BioTime’s subsidiary OncoCyte Corporation provided an update on the progress of development of PanC-Dx TM, 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-Dx TM 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-Dx TM 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-Dx TM 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-Dx TM 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-Dx TM as an in vitro diagnostic (IVD) in Europe, potentially commencing in 2014, before seeking FDA approval required to market PanC-Dx TM in the United States. Some CLIA-certified clinical laboratories may choose to offer PanC-Dx TM on a limited basis prior to EU and FDA approval.

“OncoCyte has made substantial progress in the development of PanC-Dx TM since our last update in March of 2012,” said Joseph Wagner, Ph.D., CEO of OncoCyte. “Most importantly, we have developed and characterized a large repertoire of proprietary monoclonal antibodies to a set of breast cancer-related protein markers that we have identified and validated over the last few years. OncoCyte has filed patent applications on these novel, unique markers that we believe are early indicators of the presence of breast cancer. We have manufactured substantial quantities of a subset of these proprietary antibodies that show the greatest promise and we are currently assembling ELISA-format assays. Once we have completed the validation of these assays and our clinical trial design work, we intend on initiating a large, multicenter clinical trial later this year.”

“There is a great need for rapidly deployed, effective screens to identify a wide array of human cancers at their earliest stages. A blood-based test with superior accuracy designed to detect breast cancer at early stages would have a substantial impact in the women’s health community,” said Dr. Andrew von Eschenbach, former Director of the U.S. National Cancer Institute and former U.S. Food and Drug Administration Commissioner. Dr. von Eschenbach, a specialist in urological cancer, is a member of the BioTime and OncoCyte boards of directors. “Early detection remains our current best hope for achieving cures. Therefore, the development of more accurate diagnostics and screens for all major cancer types should be a national priority.”

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