Neuralstem's ALS Trial on Clinical Hold
20 Februar 2009 - 4:00PM
PR Newswire (US)
ROCKVILLE, Md., Feb. 20 /PRNewswire-FirstCall/ -- Neuralstem, Inc.
(NYSE Alternext US: CUR) announced today its spinal cord stem cell
trial to treat ALS is on clinical hold and that the Federal Drug
Administration (FDA) has provided the Company with specific
comments, questions and recommendations for modifications to its
protocol. (Logo:
http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO ) "The FDA
has presented us with their review of our entire Investigational
New Drug (IND) application," said Richard Garr, Neuralstem's
President & CEO. "They have asked for some additional
information regarding our product manufacturing process and
pre-clinical studies, as well as our novel clinical delivery
injection device and technique. The Company believes that it can
provide this information in an expeditious manner." "The Agency has
also requested various modifications to the protocol and
eligibility criteria for patients in the trial, as well as slight
changes to the timing of the surgeries," Mr. Garr continued. "We
are evaluating these changes and will respond accordingly. The
Agency had extensive 'non hold' comments, requests for information,
and recommendations. These primarily concerned issues that will
need to be addressed for final product manufacturing and testing.
We are appreciative of their work in this area." "Over all we
believe the Agency's comments and recommendations are extremely
helpful," Garr concluded. "We are evaluating them carefully, and
expect to reach agreement with the Agency on all matters so that
the trial can be approved and move forward." About Neuralstem
Neuralstem's patented technology enables, for the first time, the
ability to produce neural stem cells of the human brain and spinal
cord in commercial quantities, and the ability to control the
differentiation of these cells into mature, physiologically
relevant human neurons and glia. Major Central Nervous System
diseases targeted by the Company with research programs currently
underway include: Ischemic Spastic Paraplegia, Traumatic Spinal
Cord Injury, Huntington's disease and Amyotrophic Lateral Sclerosis
(ALS). In pre-clinical work, the company's cells have extended the
life of rats with ALS (Lou Gehrig's disease) as reported the
journal TRANSPLANTATION, in collaboration with Johns Hopkins
University researchers, and also reversed paralysis in rats with
Ischemic Spastic Paraplegia, as reported in NEUROSCIENCE on June
29, 2007, in collaboration with researchers at University of
California San Diego. Cautionary Statement Regarding Forward
Looking Information 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 such forward-looking statements in this press
release regarding potential applications of Neuralstem's
technologies 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 Neuralstem's
periodic reports, including the annual report on Form 10- KSB for
the year ended December 31, 2007 and the quarterly report on form
10-Q for the period ended September 30, 2008.
http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO
http://photoarchive.ap.org/ DATASOURCE: Neuralstem, Inc. CONTACT:
Richard Garr, President of Neuralstem, Inc., +1- 301-366-4960; or
Media: Deanne Eagle of Planet Communications, +1-917-837-5866; or
Investors: Ina McGuinness of ICR, Inc., +1- 310-954-1100
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