SciSparc Announces Enrollment of the First Five Patients in the Clinical Trial of its Innovative SCI-210 Treatment
19 Agosto 2024 - 3:11PM
SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty
clinical-stage pharmaceutical company focusing on the development
of therapies to treat disorders of the central nervous system,
today announced that the first five patients have been enrolled and
dosed into its ongoing clinical trial in children suffering from
autism spectrum disorder ("ASD") at the Soroka Medical Center in
Israel.
The double-blind, randomized and placebo-controlled trial uses
SciSparc's proprietary SCI-210, an innovative combination
comprising cannabidiol (“CBD”) and CannAmide™ (SciSparc’s novel
Palmitoylethanolamide formulation), which is designed to alleviate
ASD symptoms. SciSparc will enroll 60 subjects between the ages of
five and 18 for 20 weeks, with the purpose of assessing how SCI-210
therapy compares to standard CBD monotherapy in managing symptoms
of ASD.
The Company's goal is to sell SCI-210 first in Israel and
then in other countries, subject to obtaining the requisite
regulatory approvals.
The trial has three primary efficacy metrics: the Aberrant
Behavior Checklist-Community (ABC-C) parent questionnaire; the
Clinical Global Impressions-Improvement (CGI-I) performed by a
clinician; and the effective therapeutic dose. The trial was
designed in consultation with the National Autism Research Center,
the leading research center for autism in Israel.
“People of all genders, ethnicities and economic backgrounds can
be diagnosed with ASD. Although ASD can be a lifelong disorder,
treatments and services can improve a person’s symptoms and daily
functioning. Consistent with our mission of improving people’s
lives, we are happy with the ongoing pace of enrollment in the
SCI-210 trial and expect that this study will generate new
scientific data so that others may be better helped in the future,”
said Oz Adler, SciSparc’ s Chief Executive Officer.
ASD is a condition related to brain development that impacts how
a person perceives and socializes with others, causing problems in
social interaction and communication. The term "spectrum" in ASD
refers to the wide range of symptoms and severity.
About SciSparc Ltd. (Nasdaq: SPRC):
SciSparc Ltd. is a specialty clinical-stage pharmaceutical
company led by an experienced team of senior executives and
scientists. SciSparc’s focus is on creating and enhancing a
portfolio of technologies and assets based on cannabinoid
pharmaceuticals. With this focus, the Company is currently engaged
in the following drug development programs based on THC and/or
non-psychoactive CBD: SCI-110 for the treatment of Tourette
Syndrome, for the treatment of Alzheimer's disease and agitation;
SCI-160 for the treatment of pain; and SCI-210 for the treatment of
ASD and status epilepticus. The Company also owns a controlling
interest in a subsidiary whose business focuses on the sale of hemp
seeds’ oil-based products on Amazon Marketplace.
Forward-Looking Statements:
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995 and other Federal
securities laws. For example, SciSparc is using forward-looking
statements when it discusses the expected progress and design of
the clinical trial, its expected commercialization strategy and its
view on the progress and effect of the clinical study. Historical
results of scientific research and clinical and preclinical trials
do not guarantee that the conclusions of future research or trials
will suggest identical or even similar conclusions. Because such
statements deal with future events and are based on SciSparc's
current expectations, they are subject to various risks and
uncertainties and actual results, performance or achievements of
SciSparc could differ materially from those described in or implied
by the statements in this press release. The forward-looking
statements contained or implied in this press release are subject
to other risks and uncertainties, including those discussed under
the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F
filed with the SEC on April 1, 2024, and in subsequent filings
with the U.S. Securities and Exchange Commission. Except as
otherwise required by law, SciSparc disclaims any intention or
obligation to update or revise any forward-looking statements,
which speak only as of the date they were made, whether as a result
of new information, future events or circumstances or
otherwise.
Investor Contact: IR@scisparc.com Tel: +972-3-6167055
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