May 14 2008, 2:30 PM EST
News source: Business Wire
Geron Corporation (Nasdaq:GERN) announced today that the company
received verbal notice today from the FDA that the company's
Investigational New Drug (IND) submission for GRNOPC1, a cell therapy
for spinal cord injury, has been placed on clinical hold. A clinical
hold is an order that the FDA issues to a sponsor to delay a proposed
trial or to suspend an ongoing investigation.
"We have not yet received a letter from the FDA explaining the
decision to place the submission on hold, so we are unable to comment
specifically," said Thomas Okarma, Ph.D., M.D., Geron's president and
chief executive officer. "Once we have the letter and have had a
discussion with the agency, we will communicate our findings and our
thinking to shareholders. We are disappointed with this action given
the interactions we had with the FDA over four years leading to the
filing, and the breadth and depth of the submission, some 21,000
pages, predicated on those discussions with the agency."
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. 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 March 31, 2008.
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