INSYS Therapeutics Initiates Phase 2 Clinical Trial of Cannabidiol (CBD) Oral Solution for Treatment of Refractory Childhoo...
December 19 2017 - 8:00AM
Can a synthetic formulation of cannabidiol (CBD), one of the main
molecules in cannabis, safely help control treatment-resistant
“staring” seizures in children with epilepsy? Working with
pediatric patients who suffer from this debilitating condition and
their clinicians, INSYS Therapeutics (NASDAQ:INSY) plans to find
out by conducting a study using its pharmaceutical-grade, synthetic
CBD.
The company today announced the initiation of a new clinical
trial of CBD oral solution—a Phase 2, open-label, dose-finding
study (INS011-17-103) that aims to assess the efficacy, safety,
tolerability and pharmacokinetics (PK) of the novel product
candidate—for refractory childhood absence epilepsy in pediatric
patients.
INSYS previously completed a two-part clinical trial
(INS011-14-029 and -030) of CBD oral solution for treatment of
refractory pediatric epilepsy, with encouraging results. A majority
of the patients in these sequentially conducted Phase 1/2 PK and
long-term safety studies experienced a reduction in seizure
frequency and/or intensity while receiving CBD oral solution.
Initial results from these studies, which continue under the
company’s “Compassionate Use” program, were presented earlier this
month at the 2017 annual meeting of the American Epilepsy Society
in Washington, D.C.
Of the more than 470,000 children in the United States who have
been diagnosed with epilepsy, an estimated 2–8 percent of these
patients have experienced absence seizures, according to the
Centers for Disease Control and Prevention (CDC) and the Epilepsy
Foundation.
“Treatment options for pediatric epilepsy patients with
refractory childhood absence seizures are limited and inadequate,”
explained Dr. Steven Phillips, a pediatric neurologist at Mary
Bridge Children’s Hospital and Health Center in Tacoma, Wash., and
an investigator in the new study. “Better treatments with greater
efficacy and fewer side effects are needed to improve quality of
life and clinical outcomes for these patients. CBD holds great
promise for this challenging form of epilepsy, and we are excited
to be involved in another study of this particularly promising
formulation of CBD from INSYS.” (Dr. Phillips also served as an
investigator in the previous CBD studies sponsored by INSYS.)
“We are very excited to begin our clinical development program
of CBD in refractory childhood absence epilepsy,” said Steve
Sherman, senior vice president of regulatory affairs at INSYS
Therapeutics. “We believe that CBD might be able to offer these
children a new alternative when traditional therapies have not been
effective or well tolerated. This clinical program demonstrates our
ongoing commitment to addressing unmet medical needs in rare
diseases and furthers our position as a pioneer in the emerging
field of pharmaceutical-grade medicinal cannabinoids.”
The study is expected to be completed in late 2018.
About INSYSINSYS Therapeutics is a specialty
pharmaceutical company that develops and commercializes innovative
drugs and novel drug delivery systems of therapeutic molecules that
improve patients’ quality of life. Using proprietary spray
technology and capabilities to develop pharmaceutical cannabinoids,
INSYS is developing a pipeline of products intending to address
unmet medical needs and the clinical shortcomings of existing
commercial products. INSYS is committed to developing medications
for potentially treating addiction to opioids, opioid overdose,
epilepsy, and other disease areas with a significant unmet
need.
Forward-Looking Statements This news
release contains forward-looking statements including our (i)
expectations as to when study results will be available or
presented and (ii) belief that CBD might be able to offer these
children a new alternative when traditional therapies. These
forward-looking statements are based on management’s expectations
and assumptions as of the date of this news release; actual results
may differ materially from those in these forward-looking
statements as a result of various factors, many of which are beyond
our control. These factors include, but are not limited to, risk
factors described in our filings with the United States Securities
and Exchange Commission, including those factors discussed under
the caption “Risk Factors” in our Annual Report on Form 10-K for
the year ended Dec. 31, 2016 and subsequent updates that may occur
in our Quarterly Reports on Form 10-Q. Forward-looking statements
speak only as of the date of this news release, and we undertake no
obligation to publicly update or revise these statements, except as
may be required by law.
CONTACT:
Media RelationsJoe McGrathCorporate CommunicationsINSYS
Therapeutics480-500-3101jmcgrath@insysrx.com
Investor RelationsJackie Marcus or Chris HodgesAlpha IR
Group312-445-2870 INSY@alpha-ir.com
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