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Geron, (GERN) CXR Biosciences And The Roslin Institute Announce Partnership To Develop In Vitro Assays Using hESC-Derived Hepatocytes

10/19/2005 5:11:27 PM

MENLO PARK, Calif. & DUNDEE, Scotland--(BUSINESS WIRE)--May 20, 2004--Geron Corporation (Nasdaq:GERN - News), CXR Biosciences Ltd. (Dundee, Scotland) and the Roslin Institute (Edinburgh, Scotland) today announced a collaboration to develop and commercialize human embryonic stem cell (hESC)-derived hepatocytes for use in in vitro assays of drug metabolism and toxicity.

Under the terms of the agreement, Geron, the Roslin Institute and CXR will collaborate to develop enhanced protocols for efficient, scalable and cost-effective derivation of hepatocytes from hESCs, to characterize their use for the metabolic and toxicological profiling of drugs in development, and to format them into in vitro assays suitable for high-throughput screening applications. Geron will bring to the partnership: i) its existing hES cell lines, ii) extensive intellectual property and know-how in the hESC field, and iii) its issued patents for hepatocytes derived from hESCs and their use in drug screening. The Roslin Institute will utilize its expertise in hESC culture and gene reporter assays, and produce hESC-derived hepatocytes under funding from Geron. CXR will contribute its expertise in hepatocyte cell culture, as well as its proprietary metabolic and reporter construct-based assays for hepatocyte function. Geron and CXR will commercialize the resulting products. Other financial terms of the agreement were not disclosed.

Sourcing of human hepatocytes for in vitro assays has long been a key problem in pharmaceutical drug development. Primary human hepatocytes have traditionally been sourced from cadavers or cancer resections, but supply of these cells is limited and phenotypes vary widely among the sourced donors. Because primary hepatocytes cannot be sustained in culture without losing function, their availability is dependant on repetitive sourcing, creating supply constraints and further contributing to assay variability. Hence, pharmaceutical companies have had to rely heavily on animal models for preclinical metabolism and toxicity testing, which are often not predictive for man. The expensive and low-throughput nature of animal models has forced such testing to be reserved for compounds in late preclinical development, requiring pharmaceutical companies to invest significant resources in compounds before their metabolism and toxicity profiles are known, which contributes to their high failure rates in late preclinical testing.

Geron's hESC-derived hepatocyte technology presents a unique opportunity to address this bottleneck in drug discovery by providing standardized hepatocyte lines that are predictive of human metabolism and toxicology. Undifferentiated hESCs maintain pluripotency and stable karyotypes after years in culture, providing a virtually limitless supply of uniform source material. Development of feeder-free and serum-free growth conditions for hESCs enable the economically viable, scalable production of commercial quantities of these cells. Geron has successfully demonstrated in vitro derivation of human hepatocytes that express drug metabolizing enzymes from hESCs. In this collaboration, the partners will develop enhanced protocols to improve yields and maturity of hESC-derived hepatocytes, and will format the resulting cells into commercially useful high-throughput assays for drug metabolism and toxicity.

"Since 1999, scientists at Roslin and Geron have worked closely together, first in the field of nuclear transfer and more recently in hESC culture and differentiation," said Professor John Clark, Director of the Roslin Institute. "Similarly, we have had a long-standing collaboration with CXR to develop gene reporter assays for toxicological stress. By combining our efforts, we can apply a uniquely diverse set of capabilities to address the pharmaceutical industry's need for better in vitro ADME/toxicology assays."

"This collaboration will apply CXR's extensive experience in using hepatocytes in drug screening to revolutionize the preclinical development process," noted Tom Shepherd, Ph.D., Chief Executive Officer of CXR Biosciences. "Developing high-throughput screens to determine the metabolic and toxicological profiles of entire families of early-stage compounds in human cells will enable pharmaceutical companies to make more informed choices regarding which compounds to develop. This will reduce the number of later stage failures, and improve cost effectiveness."

"hESC-derived hepatocytes may become the gold standard for defining hepatic metabolism and hepatotoxicity of new drugs prior to human clinical testing," added Thomas B. Okarma, Ph.D., M.D., Geron's President and Chief Executive Officer. "The successful development and application of this technology should significantly reduce unanticipated clinical liver toxicity and improve the success rate of new drug development."

Geron is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic products for cancer based on its telomerase technology, and cell-based therapeutics using its human embryonic stem cell technology.

CXR Biosciences is a privately owned company that is developing new technologies to accelerate and improve the preclinical development of pharmaceutical products. CXR both invests in the generation of new intellectual property and offers contract services in lead selection and ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicology) to pharmaceutical, chemical and biotechnology companies worldwide. The prime focus of CXR is to apply its state of the art technologies to drug development, lead selection and toxicology to accelerate drug development, reduce product attrition and attempt "rescue" when appropriate for molecules with unexplained preclinical observations.

The Roslin Institute is a not-for-profit research institute based in Edinburgh, Scotland, sponsored by the Biotechnology and Biological Sciences Research Council. It currently employs over 240 staff, students and visiting scientists who work in a wide range of disciplines including molecular and cell biology, quantitative genetics, genomics, endocrinology and developmental biology. The Institute collaborates with academic and commercial partners worldwide, and plays an important role in post-graduate education, mostly through the University of Edinburgh's Graduate School of Life Sciences.

This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding future applications of Geron's technology constitute forward-looking statements involving risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, reliance on collaborators, need for additional capital, need for regulatory approvals or clearances, and the maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Geron's periodic reports, including the quarterly report on Form 10-Q for the quarter ended March 31, 2004.



Geron Corporation

David L. Greenwood, 650-473-7765


CXR Biosciences Ltd.

Dr. Tom Shepherd, +44 (0) 138 243 2163


Roslin Institute

Dr. John Clark, +44 (0) 131 527 4478


Source: Geron Corporation

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