Geron and FDA Reach Agreement on Clinical Hold

* Reuters is not responsible for the content in this press release.

Fri Oct 30, 2009 12:30pm EDT

Company and Regulatory Agency Define Path to Re-Initiate Human Trials for Spinal
Cord Injury
MENLO PARK, Calif.--(Business Wire)--
Geron Corporation (Nasdaq: GERN) today announced the company`s plan to advance
clinical development of its human embryonic stem cell (hESC)-based product,
GRNOPC1, for the treatment of spinal cord injury. The plan is expected to enable
Geron to re-initiate the Phase I clinical trial of GRNOPC1 in patients with
complete thoracic spinal cord injury and to support future expansion of the
trial to patients with cervical injuries. 

Geron has been performing a series of preclinical studies to expand the clinical
program for spinal cord injury beyond patients with complete thoracic injuries.
The company`s goal is to test the safety and utility of GRNOPC1 in patients with
complete and incomplete (less severe) injuries in both thoracic and cervical
regions. 

As announced previously, in one preclinical study, a higher frequency of animals
developed cysts in the injury site than had been seen in numerous foregoing
preclinical studies with clinical grade GRNOPC1. These cysts are
non-proliferative, confined to the injury site, smaller than the injury cavity,
and were not associated with adverse effects on the animals. As part of ongoing
work to optimize GRNOPC1 manufacturing and product release, the company
developed new candidate markers and assays. Data from studies using the new
markers were submitted to the FDA. The IND for spinal cord injury was placed on
clinical hold pending FDA review of the data. 

Geron will complete a confirmatory preclinical study using GRNOPC1 that has been
characterized by the new markers and assays, as agreed upon in discussions with
the FDA. As part of the ongoing plan to advance clinical development to cervical
patients, Geron had already initiated this preclinical study in an animal model
of cervical injury. 

In discussions with the company, the FDA has advised that it concurs with Geron
that positive data from this study can be used to support both release of the
clinical hold and expansion to cervical patients. Geron expects the data from
this study to enable re-initiation of the clinical trial in the third quarter of
2010. 

The company is initially developing GRNOPC1 for spinal cord injury, but is also
exploring application for other neurological diseases, including multiple
sclerosis, stroke and Alzheimer disease. 

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 and
future regulatory developments 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, Ph.D., Investor and Media Relations, 650-473-7765
info@geron.com



Copyright Business Wire 2009

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