Full Press Release Details
| Deanne Eagle - Media Relations | 917.837.5866 |
| Susan Roush - Investor Relations | 818.222.8330 |
SIXTEENTH PATIENT DOSED IN NEURALSTEM
FIRST TO RECEIVE TREATMENT IN UPPER AND
ROCKVILLE, Md., June 19, 2012
-- Neuralstem, Inc. (NYSE MKT: CUR) announced that the first patient to receive stem cell transplantation in both regions of the
spinal cord has been treated in the ongoing Phase I trial of its spinal cord neural stem cells in amyotrophic lateral sclerosis
(ALS or Lou Gehrig's disease). This is also the 16th patient to be treated in the trial altogether and the first patient
returning to the trial for a second treatment. In this treatment, the patient received five injections in the cervical (upper back)
region of the spinal cord, in addition to the ten he received previously in the lumbar (lower back) region of the spine, for a
total of 15 injections. This is the highest number of injections in the trial so far. Patient 16 is also the first patient in the
world to receive stem cell transplants in both the lumbar and cervical regions of the spinal cord in an FDA-approved trial. Two
additional previously-treated patients are expected to return to the trial this summer in this cohort, provided they continue to
meet the inclusion requirements. The trial is taking place at Emory University Hospital in Atlanta, Georgia
the first of the returning patients represents a major milestone in the trial," said Dr. Karl Johe, PhD, Neuralstem's Chairman
and Chief Scientific Officer. "The ability to safely administer multiple dosings to these patients is a key enabling step
in administering the maximum safe dose. Not only are we dosing patients for a second time in this cohort, we are now dosing in
both the lumbar and cervical regions of the spinal cord for the first time, where the stem cell therapy could support both walking
The Phase I trial to assess the
safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since
January 2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar
(lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts.
The trial then advanced to transplantation
in the cervical (upper back) region of the spine. The first cohort of three was treated in the cervical region only. The current
cohort of three will receive injections in both the cervical and lumbar regions of the spinal cord. In an amendment to the trial
design, The Food and Drug Administration (FDA) approved the return of previously-treated patients to this cohort. The first of
these returning patients was just treated. The entire 18-patient trial concludes six months after the final surgery.
Neuralstem's patented technology
enables 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 constitutively into mature, physiologically relevant human neurons and glia. Neuralstem
is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's
disease, and has been awarded orphan status designation by the FDA.
In addition to ALS, the company
is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic
spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a
Phase I safety trial in chronic spinal cord injury.
Neuralstem also has the ability
to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this
proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate
new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval
from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment
of major depressive disorder (MDD). Additional indications could include CTE (chronic traumatic encephalopathy), Alzheimer's
disease, anxiety, and memory disorders.
For more information, please
visit www.neuralstem.com or connect with us on Twitter and Facebook.
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-K for the year ended December 31, 2011 or the Form 10-Q for the period
ended March 30, 2012.