GERMANTOWN, Md., Jan. 20, 2021 /PRNewswire/ -- Seneca Biopharma,
Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on
developing novel treatments for diseases of high unmet medical
need, today announced preliminary, top-line results of the
Company's placebo controlled Phase 2 stroke study (non-GCP) that
was conducted in Beijing, China.
The trial was designed to evaluate the relative safety of the
Company's human neural stem cell therapy, NSI-566, in patients with
stable deficits in motor function resulting from ischemic stroke.
Patients were eligible for the trial if they had documented history
of ischemic stroke at least four months, but no more than 24
months, before surgery.
The study enrolled 23 patients who were randomly assigned to
treatment or placebo arms. Patients in the treatment arm received
intracerebral injection of 72 million stem cells, whereas those in
the placebo group underwent a sham surgery procedure. Secondary
objectives to evaluate efficacy were performed by qualified
assessors who were blinded to treatment assignment, and included
the Fugl-Meyer Motor Score (FMMS), an assessment of upper and lower
motor function that comprises a 100 point scale and is widely used
following stroke.
Patients enrolled in the treatment and placebo arms had similar
baseline FMMS scores before surgery (mean ± SD: 36.80 ± 8.59 and
35.80 ± 4.66, respectively). While most participants showed some
improvement in FMMS from pre-surgery scores, the mean improvement
after one year was greater in those participants receiving NSI-566
(n=10, mean ± SD: 12.20 ± 14.15) compared to placebo (n=10, 6.30 ±
5.14), though the difference between groups did not reach
statistical significance using the approximate Student's t-test
(MMRM) (p=0.231). Two participants in the treatment arm showed
clinically important improvements of 32 and 44 points on the FMMS
following treatment with NSI-566, whereas the largest improvement
observed in the placebo group was 17 points. Participants in the
treatment arm experienced a total of three serious adverse events
(SAE) that were considered by the investigator to be probably or
possibly related to treatment, whereas no patients in the placebo
arm experienced SAEs. Treatment-related SAEs were resolved with
standard medical care and were limited to impaired healing at the
incision site and wound dehiscence in one patient, and impaired
hepatic function in another.
"Stroke is a leading cause of death and disability in
China," said professor Ruxiang Xu,
former president of BaYi Brain Hospital in Beijing, China and study principal
investigator. "Results from this study show NSI-566 may have
utility as a treatment for paralysis and motor deficits caused by
ischemic stroke. Additional larger studies will be critical in
demonstrating the clinical potential of NSI-566 in this unmet
need."
About Seneca Biopharma, Inc.
Seneca Biopharma, Inc., is a clinical-stage biopharmaceutical
company developing novel treatments for diseases of high unmet
medical need. On December 17, 2020,
Seneca announced that it had
entered into a definitive Merger Agreement with Leading
BioSciences, Inc. (LBS), a privately held company focused on
developing novel therapeutics to improve human health through
therapeutic protection of the gastrointestinal mucosal barrier.
Pursuant to the Merger Agreement, Seneca is seeking to sell off its rights to
NSI-566. Upon completion of the merger, the company is expected to
operate under the name Palisade Bio, Inc. and trade on the Nasdaq
Capital Market under the ticker symbol PALI.
About Ischemic Stroke
Ischemic stroke, the most common type of stroke, occurs as a
result of an obstruction within a blood vessel supplying blood to
the brain. Approximately 15 million people worldwide suffer stroke
each year, of which approximately 87% are ischemic strokes.
Post-stroke motor deficits include paralysis in arms and legs and
can be permanent. No interventional therapy exists for chronic
stroke and treatment is focused on rehabilitation, but only a small
fraction of survivors achieves complete functional recovery.
Cautionary Statement Regarding Forward Looking
Information:
This news release contains "forward-looking statements" made
pursuant to the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements
relate to future, not past, events and may often be identified by
words such as "expect," "anticipate," "intend," "plan," "believe,"
"seek" or "will." Forward-looking statements by their nature
address matters that are, to different degrees, uncertain. Specific
risks and uncertainties that could cause our actual results to
differ materially from those expressed in our forward-looking
statements include 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 Seneca's
periodic reports filed with the Securities and Exchange Commission
(SEC), including its Annual Report on Form 10-K for the year ended
December 31, 2019, its Quarterly
Reports on Form 10-Q as well as and in other reports filed with the
SEC. We do not assume any obligation to update any forward-looking
statements.
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SOURCE Seneca Biopharma, Inc.