Stem cell breakthroughs within Cyte?

ALAMEDA, Calif.—BioTime Inc. announced in early Septemberthat it has entered into an exclusive license agreement with Cornell Universityfor the worldwide development and commercialization of technology developed atthe university for the differentiation of human embryonic stem cells (hESCs)into vascular endothelial cells.

BioTime is a biotechnology company focused on regenerativemedicine and blood plasma volume expanders that carries out much of its work inthe human stem cell space. The company has numerous subsidiaries that carry outwork in a range of diseases and conditions.

According to the companies, the new methods will provide an improved means ofgenerating these cells on a large scale. BioTime will employ the technology intwo of its subsidiaries: ReCyte Therapeutics Inc. and OncoCyte Corp.

ReCyte targets age-related vascular disease, and OncoCytewill use the technology to find a way to deliver a toxic payload to canceroustumors. The work at both spinoffs relies on the work of capillaries, which playa role in vascular health and also provide a route directly into tumors.

Vascular endothelial cells form the tubular structure ofcapillaries, and the innermost cells of larger arteries and veins in the body. Whenthese cells become dysfunctional, they are believed to play a key role innumerous disease processes such as coronary heart disease and stroke.

The technology was developed at the Weill Cornell MedicalCollege. The journal Nature Biotechnologypublished a story about the work in 2010.

The ability to reprogram cell lifespan and manufacture youngand healthy patient-specific vascular endothelial cells may prove to beimportant in the emerging field of regenerative medicine.

BioTime has tested the Cornell technology when combined with BioTime'sACTCellerate technology and has successfully produced highly purifiedmonoclonal embryonic vascular endothelium. This high level of purity andscalability is expected to facilitate the manufacture of clinical-grade cellsthat may be used for transplantation therapies.

"The technology invented by Drs. Shahin Rafii and Daylon James of the WeillCornell Medical College is both elegant and useful, and may provide a means togenerate virtually limitless quantities of high quality vascular cells," saysDr. Joseph Wagner, CEO of OncoCyte, in a prepared statement. "The productsderived from the combination of this technology with BioTime's ACTCellerate andOncoCyte's existing technologies to target and destroy malignant tumors, maylead to an entirely new modality for the treatment of solid tumors."

BioTime's license is worldwide and exclusive for the fieldsof cell therapy for age- and diabetes-related vascular diseases and cancertherapy. The license also covers products utilizing human vascular or vascularforming cells for the purpose of enhancing the viability of the graft of otherhuman cell types, and cell-based research products.

"In addition to obtaining exclusive worldwide licenses tothe patent-pending Cornell technology, we have entered into a sponsoredresearch agreement with Weill Cornell Medical College that will utilize theexpertise of the scientists who developed the licensed technology," said Dr.Steve Kessler, vice president of research and development of ReCyte, in aprepared statement. "This collaboration will allow ReCyte Therapeutics'scientists to collaborate with leading scientists at Cornell in the field ofvascular biology, accelerating requisite animal and preclinical testing priorto human clinical use."

Cornell and BioTime representatives did not answer questionsposed to them for this story by press time.

BioTime, headquartered in Alameda, Calif., has a broadplatform of stem cell technologies is developed through subsidiaries focused onspecific fields of applications. BioTime develops and markets research productsin the field of stem cells and regenerative medicine, including a wide array ofproprietary ACTCellerate cell lines, culture media and differentiation kits.

OncoCyte focuses on developing genetic markers for the diagnosis of cancer andon applications of stem cell technology in cancer treatment, including usingvascular progenitor cells engineered to destroy malignant tumors. ReCyte isdeveloping applications of BioTime's pluripotent stem cell-derived products forthe regeneration, repair or protection of diseased or injured tissue, with aparticular emphasis on age-related vascular and related disorders.

BioTime receives NIH approval for four hESC lines

ALAMEDA, Calif.—BioTime Inc. also recently announced thatfour human embryonic stem cell (hESC) lines—ESI-035, ESI-049, ESI-051 andESI-053—developed by a BioTime subsidiary have been approved by the NationalInstitutes of Health (NIH) for inclusion in the NIH Human Embryonic Stem CellRegistry.

The approval opens the door to the use of these cell linesin federally funded research.

The lines were developed by ES Cell International Pte. Ltd.(ESI). The lines were derived using procedures and documentation that are incompliance with current Good Tissue Practices (cGTP) and current GoodManufacturing Practices (cGMP), are free of animal feeder cells and have beenassessed for pluripotency and karyotypic stability.

In collaboration with the California Institute ofRegenerative Medicine, BioTime has supplied research-grade versions of theselines to dozens of researchers throughout California, including those in theUniversity of California system. BioTime has agreed to provide the completegenome sequence to the public this fall to facilitate the development ofproducts derived from these cell lines. One of the ESI cell lines is beingevaluated by an undisclosed large pharmaceutical company for potential use inits product development program.

"We believe these six human embryonic stem cell lines nowapproved for federal funding are the largest set of GMP-compliant linesavailable to U.S. researchers," said Dr. Michael D. West, president and CEO ofBioTime, in a statement. "As researchers work towards developingtherapeutics for use in hard-to-treat diseases, we believe that ourclinical-grade hESC lines will enable them to easily translate scientificprogress into commercially successful therapeutic products."

BioTime previously announced the inclusion of ESI-014 andESI-017 to the NIH Human Embryonic Stem Cell Registry.