NIH approves BioTime's four GMP human embryonic stem cell lines

BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that four human embryonic stem (hES) cell 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. This approval opens the door to the use of these cell lines in federally funded research. BioTime previously announced the inclusion of ESI-014 and ESI-017 to the NIH Human Embryonic Stem Cell Registry.

"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 Michael D. West, Ph.D., President and CEO of BioTime. "As researchers work towards developing therapeutics for use in hard-to-treat diseases, we believe that our clinical grade hES cell lines will enable them to easily translate scientific progress into commercially successful therapeutic products."

ESI-035, ESI-049, ESI-051 and ESI-053 were developed by ES Cell International Pte. Ltd. (ESI), a wholly owned subsidiary of BioTime. ESI is one of the earliest pioneers of human embryonic stem cell technology. The ESI hES cell 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 by the fall of 2011 to facilitate the development of products derived from these cell lines. One of the ESI cell lines is being evaluated by a large pharmaceutical company for potential use in its product development program.

The NIH created the Human Embryonic Stem Cell Registry in 2001 to facilitate research using human embryonic stem cells. The registry includes hES cell lines that meet certain eligibility criteria including ethical derivation and informed consent. Only research projects using hES cell lines listed in the Registry are eligible for federal funding.