Full Press Release Details
FDA Reach Agreement on Clinical Hold
and Regulatory Agency Define Path to Re-Initiate Human Trials for Spinal
MENLO PARK, Calif.--(BUSINESS WIRE)--October 30, 2009--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.
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.
Anna Krassowska, Ph.D., Investor and
Media Relations, 650-473-7765