Geron Comments on FDA Hold on Spinal Cord Injury Trial

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Thu Aug 27, 2009 7:30am EDT

MENLO PARK, Calif.--(Business Wire)--
Geron Corporation (Nasdaq:GERN) today provided additional comments on the recent
clinical hold on its Spinal Cord Injury IND. 

As biologic therapeutics advance in clinical trials, it is common practice to
optimize product characteristics, improve manufacturing efficiency and scale,
and to test the product in multiple disease models. As part of these ongoing
efforts at Geron with respect to GRNOPC1, various animal studies were, and
continue to be, performed to characterize the product`s effects in vivo. In
previous animal studies of GRNOPC1 using materials that passed release
specifications, a very low frequency of injected animals developed microscopic
cysts in the regenerating injury site. These cysts were non-proliferative,
confined to the injury site, and had no adverse effects on the animals. No
animals developed teratomas or any other ectopic structure. Cysts of much larger
size appear in the spinal cord scar tissue of up to 50% of patients with spinal
cord injury. 

A just completed animal study showed a higher frequency of cysts, although their
characteristics were similar to the cysts seen in previous studies:
non-proliferative, confined to the injury site, smaller than the injury cavity
and not associated with adverse clinical outcomes. 

As part of our ongoing product improvement efforts, new candidate markers and
assays for product release have been identified that are linked with cyst
formation across all animal studies in which cysts were found. Importantly, a
manufactured lot of GRNOPC1 that was assessed using these markers and assays
showed no cysts in another recently concluded animal study in spinal cord
injured rats. 

We have submitted these data to the FDA and are in discussions with the agency
to answer its questions and proceed with the clinical trial. We are committed to
the optimization of all our hESC-based products as we improve the manufacturing
process and identify improved product release criteria. 

About Geron 

Geron is developing first-in-class biopharmaceuticals for the treatment of
cancer and chronic degenerative diseases, including spinal cord injury, heart
failure and diabetes. The company is advancing an anti-cancer drug and a cancer
vaccine that target the enzyme telomerase through multiple clinical trials in
different cancers. For more information, visit www.geron.com. 

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 statements in this press release regarding
potential applications of Geron`s human embryonic stem cell technology
constitute forward-looking statements that involve risks and uncertainties,
including, without limitation, risks inherent in the development and
commercialization of potential products, uncertainty of clinical trial results
or regulatory approvals or clearances, need for future capital, dependence upon
collaborators and 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 June 30, 2009. 





Geron Corporation
Anna Krassowska, 650-473-7765
Investor and Media Relations
info@geron.com



Copyright Business Wire 2009

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