Full Press Release Details
IND for Spinal Cord Injury Placed on Hold
MENLO PARK, Calif.--(BUSINESS WIRE)--August 18, 2009--Geron Corporation
(Nasdaq:GERN) today announced that its IND (Investigational New Drug
application) for GRNOPC1, a cell therapy for neurologically complete,
subacute spinal cord injury, has been placed on clinical hold by the FDA
pending the agency's review of new nonclinical animal study data
submitted by the company. A clinical hold is an order that the FDA
issues to a sponsor to delay a proposed trial or to suspend an ongoing
Since filing the IND, Geron has been undertaking studies to enable dose
escalation of its spinal cord injury product, and has been investigating
application of the product to other neurodegenerative diseases. The
company has also been performing additional product characterization and
conducting further animal studies. Data from this work has been
submitted to the FDA. Geron will work closely with the FDA to facilitate
their review of the new data and to release the clinical hold. No
patients have yet been treated in this study.
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.
Anna Krassowska, 650-473-7765