Attached files
file | filename |
---|---|
8-K - PALISADE BIO, INC. | v210745_8-k.htm |
Exhibit
99.01
Contact:
Meg McElroy, Shareholder
Relations
|
301.366.4960
|
Deanne Eagle, Media
Relations
|
917.837.5866
|
Susan Roush, Investor
Relations
|
818.222.8330
|
NEURALSTEM
UPDATES ALS CLINICAL TRIAL PROGRESS
APPROVED
TO DOSE LAST COHORT OF PATIENTS
ROCKVILLE, Maryland,
February
10, 2011 – Neuralstem, Inc. (NYSE Amex:
CUR) updated the progress of its ongoing Phase I human clinical trial of the
company’s spinal cord stem cells in the treatment of ALS (amyotrophic lateral
sclerosis, or Lou Gehrig’s disease) at Emory University in
Atlanta, Georgia. The company announced that, after reviewing the safety
data from the first nine patients, the trial’s Safety Monitoring Board has
unanimously approved moving to the last group of ALS patients in this part of
the safety trial. These next three patients, all of whom are ambulatory, will
each receive ten injections, bilaterally, in the lumbar spinal cord. After this
cohort, the FDA will review the trial data to date before approving it to move
into the final cohort of patients, who will receive injections in the cervical
region of the spinal cord.
“We are
delighted that we’ve advanced to this final cohort of patients in the first part
of the safety trial,” commented Dr. Eva Feldman, PhD, MD, Principal
Investigator of the trial and a consultant to Neuralstem. Dr. Feldman is
Director of the A. Alfred Taubman Medical Research Institute and Director of
Research of the ALS Clinic at the University of Michigan Health System. “We have
been pleased with the smooth progress of the trial thus far, from non-ambulatory
to ambulatory patients who have an earlier stage of the disease.”
“We
are greatly encouraged by the SMB’s approval to advance the trial to the final
three patients to receive full lumbar injections,” said Karl Johe, PhD, Chief
Scientific Officer and Chairman of Neuralstem’s Board of Directors. “The trial
has progressed as expected, and we are deeply indebted to the patients and
families who have taken part.”
About
The Trial
The Phase
I trial to evaluate the safety of Neuralstem’s spinal cord stem cells in the
treatment of ALS, the first FDA-approved ALS stem cell trial, has been underway
since January, 2010. The trial plans to enroll up to 18 ALS patients, who will
be examined at regular intervals post-surgery.
All of
the first six patients treated in the trial were non-ambulatory. Of these, the
first three received five injections each, unilaterally, in the lumbar region of
the spinal cord. The next three patients received ten injections each,
bilaterally in the lumbar region. All remaining trial patients are ambulatory,
and therefore represent earlier stages of disease progression. Of the ambulatory
group, the first three patients received five injections each, unilaterally, in
the lumbar region. The next three, which have just been approved, will receive
ten injections each, bilaterally, in the lumbar region. After the required FDA
approval, the final six patients in the trial will receive injections in the
cervical region.
While the
trial is evaluating only the safety of the cells and procedure, it includes
exploratory endpoints including attenuation of motor function loss, maintenance
of respiratory capacity, and stabilization of patients along the ALS functional
rating scale.
The Emory
ALS Center has posted the relevant trial information for patients on its website
at http://www.neurology.emory.edu/ALS/Stem%20Cell.html.
About
Neuralstem
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 a FDA-approved Phase I safety clinical trial for
amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease,
which has been rewarded Orphan Drug Status by the FDA.
In addition to ALS, the company is also
targeting major central nervous system diseases, including traumatic spinal cord
injury, ischemic spastic paraplegia, and Huntington's disease. The company has
also 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 been approved to commence a Phase Ia safety trial evaluating NSI-189, its first small molecule
compound, for the treatment of major depression. Additional
indications could include schizophrenia, Alzheimer's disease,
traumatic brain injury, posttraumatic stress syndrome, and
stroke.
For more information, please go to
www.neuralstem.com.
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, 2009,
and in its quarterly report on Form 10-Q for the period ended September 30,
2010.
# # #