- PanC-DxTM Markers to be Tested in Multi-Center Lung Cancer Study Currently Underway -
ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX), and its subsidiary OncoCyte Corporation today announced that OncoCyte has entered into a Sponsored Research Agreement and a Material Transfer Agreement with The Wistar Institute to collaboratively develop lung cancer diagnostic products. As part of the collaboration, Wistar investigators are conducting a multi-center patient study in which they are assessing gene expression patterns in blood cells of patients with malignant versus non-malignant lung disease. OncoCyte scientists will analyze blood samples obtained from patients in the study to determine levels of tumor-associated proteins using its proprietary PanC-Dx(TM) diagnostic tests. PanC-Dx(TM) is a class of non-invasive cancer diagnostics based on a proprietary set of cancer markers characterized, in part, by broad gene expression patterns in numerous cancer types.
The inclusion of the PanC-DxTM markers in Wistar's ongoing multi-center study may allow OncoCyte to more rapidly develop a diagnostic test for lung cancer to be marketed in the U.S. and other countries. The performance of markers tested in the study in determining the presence or the progression of disease in various categories of patients may determine the specific nature of the lung cancer test to be developed and the regulatory approval pathway that OncoCyte will pursue. OncoCyte will have an option to exclusively license any inventions, discoveries or technology developed by Wistar, or by OncoCyte using Wistar technology, in the course of the collaborative research.
Wistar investigators, led by Louise Showe, Ph.D., have previously demonstrated the feasibility of detecting early stage lung cancer by taking a snapshot of gene activity in circulating blood cells. Lung cancer remains a primary cause of cancer-related death, in part because there is no effective diagnostic test to screen patients for lung cancer at an early stage. The current study is being conducted on patients recruited through grant partners at multiple clinical sites. Thus far over 400 patient samples out of a planned total of 600 have been obtained. Completion of the study, which began mid-2012, is expected in mid-2014.
"I look forward to collaborating with the OncoCyte team to validate blood-based molecular markers for the diagnosis of cancer," said Dr. Showe, a professor in the Molecular and Cellular Oncogenesis program of Wistar's NCI-designated Cancer Center. "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 lung cancer. In addition to the development of a diagnostic gene panel, our previous studies provided new insights into the interactions of cancer and the immune system. We look forward to expanding those studies through this collaboration."
"We are impressed by the quality of the genomics and bioinformatics capabilities at The Wistar Institute. These capabilities, combined with Wistar's ongoing access to patient samples, are expected to accelerate the development of a blood-based lung cancer diagnostic and strategically fits into our overall PanC-Dx(TM) development strategy," said Joseph Wagner, PhD, OncoCyte's Chief Executive Officer.
OncoCyte has previously published in peer-reviewed scientific journals data relating to two PanC-Dx(TM) markers: COL10A1, a marker associated with the vasculature of numerous solid tumors, and FSIP1, a marker unique to breast cancer.
"We believe the formula for leadership in the emerging field of regenerative medicine is to have a balanced product development strategy that includes both products like PanC-Dx(TM) that may be developed and commercialized in the near term, and therapeutic products derived from pluripotent stem cell technology that will require a longer path to commercialization but that have the potential to successfully treat large patient populations with high unmet medical needs. OncoCyte's diagnostic patient study collaboration with the Wistar Institute is one component of that strategy, as is the recent entry in to human clinicals of Renevia(TM), and the development of pluripotent stem cell therapies at some of our subsidiaries, including Asterias Biotherapeutics, Inc. and Cell Cure Neurosciences Ltd.," said Dr. Michael West, BioTime's Chief Executive Officer.
About The Wistar Institute
The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the country, Wistar has long held the prestigious Cancer Center designation from the National Cancer Institute. The Institute works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. The Wistar Institute: Today's Discoveries - Tomorrow's Cures. On the Web at www.wistar.org.
About BioTime, Inc.
BioTime is a biotechnology company engaged in research and product development in the field of regenerative medicine. Regenerative medicine refers to therapies based on stem cell technology that are designed to rebuild cell and tissue function lost due to degenerative disease or injury. BioTime's focus is on pluripotent stem cell technology based on human embryonic stem ("hES") cells and induced pluripotent stem ("iPS") cells. hES and iPS cells provide a means of manufacturing every cell type in the human body and therefore show considerable promise for the development of a number of new therapeutic products. BioTime's therapeutic and research products include a wide array of proprietary PureStem(TM) progenitors, HyStem(R) hydrogels, culture media, and differentiation kits. BioTime is developing Renevia(TM) (a HyStem(R) product) as a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. In addition, BioTime has developed Hextend(R), a blood plasma volume expander for use in surgery, emergency trauma treatment and other applications. Hextend(R) is manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research, therapeutic, and diagnostic use through its subsidiaries:
-- OncoCyte Corporation is developing products and technologies to diagnose
and treat cancer.
-- ES Cell International Pte Ltd., a Singapore private limited company,
develops hES products for research use.
-- BioTime Asia, Limited, a Hong Kong company, sells products for research
use and may develop therapies to treat cancer, neurological, and
-- OrthoCyte Corporation is developing therapies to treat orthopedic
disorders, diseases and injuries.
-- ReCyte Therapeutics, Inc. is developing therapies to treat a variety of
blood and lymphatic vascular disorders, as well as products for research
using iPS and other cell reprogramming technology.
-- Cell Cure Neurosciences Ltd. is an Israel-based biotechnology company
focused on developing stem cell-based therapies for retinal and
neurological degenerative diseases. Its lead product is OpRegen(R) for
the treatment of macular degeneration.
-- LifeMap Sciences, Inc. markets, sells and distributes GeneCards(R), the
leading human gene database, the leading human gene database, as part of
an integrated database suite that also includes the LifeMap Discovery
(TM) database of embryonic development, stem cell research and
regenerative medicine, and MalaCards, the human disease database.
LifeMap Sciences also markets BioTime research products and PanDaTox, an
innovative, recently developed, searchable database that can aid in the
discovery of new antibiotics and biotechnologically beneficial products.
-- Asterias Biotherapeutics, Inc. is a new subsidiary that recently
acquired the stem cell assets of Geron Corporation, including patents
and other intellectual property, biological materials, reagents and
equipment for the development of new therapeutic products for
regenerative medicine. Additional information about BioTime can be found on the web at www.biotimeinc.com.
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.
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Source: BioTime, Inc.
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