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Stem cell breakthroughs within Cyte?
October 2011
by Kimberley Sirk  |  Email the author


ALAMEDA, Calif.—BioTime Inc. announced in early September that it has entered into an exclusive license agreement with Cornell University for the worldwide development and commercialization of technology developed at the university for the differentiation of human embryonic stem cells (hESCs) into vascular endothelial cells. 
BioTime is a biotechnology company focused on regenerative medicine and blood plasma volume expanders that carries out much of its work in the human stem cell space. The company has numerous subsidiaries that carry out work in a range of diseases and conditions.
According to the companies, the new methods will provide an improved means of generating these cells on a large scale. BioTime will employ the technology in two of its subsidiaries: ReCyte Therapeutics Inc. and OncoCyte Corp.  
ReCyte targets age-related vascular disease, and OncoCyte will use the technology to find a way to deliver a toxic payload to cancerous tumors. The work at both spinoffs relies on the work of capillaries, which play a role in vascular health and also provide a route directly into tumors. Vascular endothelial cells form the tubular structure of capillaries, and the innermost cells of larger arteries and veins in the body. When these cells become dysfunctional, they are believed to play a key role in numerous disease processes such as coronary heart disease and stroke.  
The technology was developed at the Weill Cornell Medical College. The journal Nature Biotechnology published a story about the work in 2010.  
The ability to reprogram cell lifespan and manufacture young and healthy patient-specific vascular endothelial cells may prove to be important in the emerging field of regenerative medicine.
BioTime has tested the Cornell technology when combined with BioTime's ACTCellerate technology and has successfully produced highly purified monoclonal embryonic vascular endothelium. This high level of purity and scalability is expected to facilitate the manufacture of clinical-grade cells that may be used for transplantation therapies.
"The technology invented by Drs. Shahin Rafii and Daylon James of the Weill Cornell Medical College is both elegant and useful, and may provide a means to generate virtually limitless quantities of high quality vascular cells," says Dr. Joseph Wagner, CEO of OncoCyte, in a prepared statement. "The products derived from the combination of this technology with BioTime 's ACTCellerate and OncoCyte's existing technologies to target and destroy malignant tumors, may lead to an entirely new modality for the treatment of solid tumors."  
BioTime's license is worldwide and exclusive for the fields of cell therapy for age- and diabetes-related vascular diseases and cancer therapy. The license also covers products utilizing human vascular or vascular forming cells for the purpose of enhancing the viability of the graft of other human cell types, and cell-based research products.  
"In addition to obtaining exclusive worldwide licenses to the patent-pending Cornell technology, we have entered into a sponsored research agreement with Weill Cornell Medical College that will utilize the expertise of the scientists who developed the licensed technology," said Dr. Steve Kessler, vice president of research and development of ReCyte, in a prepared statement. "This collaboration will allow ReCyte Therapeutics' scientists to collaborate with leading scientists at Cornell in the field of vascular biology, accelerating requisite animal and preclinical testing prior to human clinical use." Cornell and BioTime representatives did not answer questions posed to them for this story by press time.  
BioTime, headquartered in Alameda, Calif., has a broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media and differentiation kits.
OncoCyte focuses on developing genetic markers for the diagnosis of cancer and on applications of stem cell technology in cancer treatment, including using vascular progenitor cells engineered to destroy malignant tumors. ReCyte is developing applications of BioTime's pluripotent stem cell-derived products for the regeneration, repair or protection of diseased or injured tissue, with a particular emphasis on age-related vascular and related disorders.

BioTime receives NIH approval for four hESC lines
ALAMEDA, Calif.—BioTime Inc. also recently announced that four human embryonic stem cell (hESC) lines—ESI-035, ESI-049, ESI-051 and ESI-053—developed by a BioTime subsidiary have been approved by the National Institutes of Health (NIH) for inclusion in the NIH Human Embryonic Stem Cell Registry.
The approval opens the door to the use of these cell lines in federally funded research. The lines were developed by ES Cell International Pte. Ltd. (ESI). The lines were derived using procedures and documentation that are in compliance with current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP), are free of animal feeder cells and have been assessed for pluripotency and karyotypic stability.
In collaboration with the California Institute of Regenerative Medicine, BioTime has supplied research-grade versions of these lines to dozens of researchers throughout California, including those in the University of California system. BioTime has agreed to provide the complete genome sequence to the public this fall to facilitate the development of products derived from these cell lines. One of the ESI cell lines is being evaluated by an undisclosed large pharmaceutical company for potential use in its product development program.
"We believe these six human embryonic stem cell lines now approved for federal funding are the largest set of GMP-compliant lines available to U.S. researchers," said Dr. Michael D. West, president and CEO of BioTime, in a statement. "As researchers work towards developing therapeutics for use in hard-to-treat diseases, we believe that our clinical-grade hESC lines will enable them to easily translate scientific progress into commercially successful therapeutic products."  
BioTime previously announced the inclusion of ESI-014 and ESI-017 to the NIH Human Embryonic Stem Cell Registry.  

Code: E101124



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