SciSparc Announces Initiation of Patient Recruitment for its Clinical Trial with SCI-210 in Children with Autism Spectrum Disorder
29 Enero 2024 - 6:18AM
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 announces the initiation of patient recruitment for its
clinical trial in children suffering from autism spectrum disorder
("ASD") at Soroka Medical Center in Israel.
The double-blind, randomized and
placebo-controlled study will be performed using SciSparc's
proprietary SCI-210, a combination of cannabidiol (CBD) and
CannAmide™(SciSparc’s Palmitoylethanolamide), 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 treatment 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 initiation of patient recruitment for this
clinical study, that has the potential to address an area of unmet
medical need, marks an exciting milestone for the team at SciSparc
as it aligns with our mission to improve human health through the
development of novel therapies," said SciSparc’s Chief Executive
Officer, Oz Adler. “We hope the outcome of the trial will enable
the Company to procced with the commercialization process for
SCI-210 in Israel."
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.
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 autism spectrum disorder 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 prospective design
and objectives of the clinical trial, the Company’s
commercialization intent with regards to SCI-210, the potential of
the clinical study to address ASD, and the potential
commercialization of SCI-210 in Israel. 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 May 1, 2023, 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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