PHILADELPHIA, Oct. 29, 2016 /PRNewswire/ -- Medgenics, Inc.
(NASDAQ: MDGN) – New data presented at AACAP's 63rd
Annual Meeting (Oct. 24-29, 2016 in
New York, NY) confirmed the
presence of specific genetic mutations in many children with
Attention Deficit Hyperactivity Disorder (ADHD). The study
team, led by Dr. Josephine Elia,
M.D., Neuroscience Center, Department of Child and Adolescent
Psychiatry, Nemours/Alfred I. DuPont Hospital for Children, studied
a US population of children suffering from ADHD. The data
confirm the observations previously made by Dr. Elia and colleagues
at The Children's Hospital of Philadelphia (CHOP) in 2010 and underscore the
importance of the role of glutamate receptors (mGluR) in diseases
like ADHD. The study was sponsored by Medgenics, Inc.
![Medgenics, Inc. logo Medgenics, Inc. logo](https://photos.prnewswire.com/prnvar/20161026/433008LOGO)
"There is increasing interest in the critical role of glutamate
neurotransmission in ADHD and other neuropsychiatric disorders,"
said Josephine Elia, M.D.,
Neuroscience Center, Department of Child and Adolescent Psychiatry,
Nemours/Alfred I. DuPont Hospital for Children and principal study
investigator. "This study suggests that mutations that can disable
genes in this critical network can be causally associated with
ADHD. Such mutations are present in up to 25 percent of
children with ADHD, and suggest new genomics targeting strategies
to better treat the disease."
A total of 23 investigators in centers across the USA enrolled 1,013 children, aged 6-17 years,
with established ADHD. Phenotype data was collected and
saliva samples were submitted to The Center for Applied Genomics
(CAG) at CHOP for genotyping. Overall, the mutation frequency was
22%, with a higher prevalence of 25% observed in patients aged
6-12. Interestingly, when compared to mutation negative ADHD
patients, the patients with the mGluR mutations were more likely to
have concerns about anger control and disruptive behaviors.
Medgenics is currently conducting additional research to better
understand the relative severity of ADHD in patients with a network
mutation and the contribution of individual genes.
"The results of this study support our ongoing Phase 2/3
interventional adolescent ADHD trial, known as SAGA" said
Liza Squires, M.D., Vice President,
Research & Development, Medgenics, Inc. "Our ultimate aim is to
develop a genomically targeted, safe and superior product for this
subpopulation of ADHD patients. This would be the first such
targeted therapy in any CNS disease and highlights the emergence of
precision medicine in this therapeutic area."
ADHD is the most common neurodevelopmental disorder of childhood
and is generally characterized as a persistent pattern of
inattention and/or hyperactivity-impulsivity that interferes with
functioning or development. Approximately 11% – or 6.4
million – of U.S. children (4-17 years of age) have been diagnosed
with ADHD, according to a recent study conducted by the Centers for
Disease Control and Prevention (CDC) and the Health Resources and
Services Administration.[1]
POSTER INFORMATION
Poster 6.67: Glutamatergic Network Gene Mutations in
Adolescents and Children with Attention Deficit Hyperactivity
Disorder (ADHD)
Saturday, October
29, 2016 | 10:00am-12:30pm
ET
Josephine Elia, M.D.,
Neuroscience Center, Department of Child and Adolescent Psychiatry,
Nemours/Alfred I. DuPont Hospital for Children, presented findings
estimating the prevalence of rare, recurring copy number variants
(CNVs) of specific metabotropic glutamate receptor (GRM, mGluR) and
related network genes in a pediatric population with ADHD.
An abstract of the accepted presentation can be accessed on
AACAP's 63rd Annual Meeting website.
About the SAGA Trial
The purpose of this multicenter,
dose-optimized trial in adolescents with ADHD is to confirm the
results from the Phase 1b GREAT study. The trial is designed as a
randomized, double-blind, placebo-controlled, parallel-group Phase
2/3 study of NFC-1 versus placebo in adolescent patients with ADHD
who have genetic disorders impacting the mGluR network. The trial
will enroll 90 patients between the ages of 12 to 17 years old. The
primary and key secondary endpoints in the trial will be the change
from baseline in the ADHD-rating scale Total Score (ADHD-RS-5) and
change from baseline in Clinical Global Impression - Global
Improvement Scale (CGI-I). Patients will be randomized 1:1 to
receive either a six-week course of NFC-1 or placebo, with a
one-week follow-up. Patients will be enrolled from the same 25
sites that were used in the recent phenotype/genotype study. More
information on the SAGA trial is available at
www.ClinicalTrials.gov (Identifier: NCT02777931).
About Medgenics, Inc.
Medgenics, Inc. is dedicated to
unlocking the potential of genomic medicine to identify and treat
patients with life-altering conditions. Its efforts, including its
internal research and development and ongoing sponsored research
and licensing agreements with a well-respected pediatric academic
medical center, give Medgenics the ability to focus on
the underlying genetic pathway of pediatric diseases with the goal
of finding therapeutic solutions for subpopulations of both
children and adults living with rare and other difficult-to-treat
diseases. Medgenics is also the developer of
TARGT™ (Transduced Autologous Restorative Gene
Therapy), a proprietary gene therapy platform. For more
information, visit the Company's website at www.medgenics.com.
Forward-looking Statements
This release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and as that term is defined in the Private
Securities Litigation Reform Act of 1995, which include all
statements other than statements of historical fact, including
(without limitation) those regarding the Company's financial
position, its development and business strategy, its product
candidates and the plans and objectives of management for future
operations. The Company intends that such forward-looking
statements be subject to the safe harbors created by such laws.
Forward-looking statements are sometimes identified by their use of
the terms and phrases such as "estimate," "project," "intend,"
"forecast," "anticipate," "plan," "planning," "expect," "believe,"
"will," "will likely," "should," "could," "would," "may" or the
negative of such terms and other comparable terminology. All such
forward-looking statements are based on current expectations and
are subject to risks and uncertainties. Should any of these risks
or uncertainties materialize, or should any of the Company's
assumptions prove incorrect, actual results may differ materially
from those included within these forward-looking statements.
Accordingly, no undue reliance should be placed on these
forward-looking statements, which speak only as of the date made.
The Company expressly disclaims any obligation or undertaking to
disseminate any updates or revisions to any forward-looking
statements contained herein to reflect any change in the Company's
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
As a result of these factors, the events described in the
forward-looking statements contained in this release may not
occur.
Contacts:
Medgenics, Inc.
Brian Piper
240-899-5554
Brian.Piper@medgenics.com
For Media
Tonic Life Communications
Melissa Maycott
609-636-3939
melissa.maycott@toniclc.com
For Investors
Westwicke Partners
Chris Brinzey
339-970-2843
chris.brinzey@westwicke.com
[1] Centers for Disease Control and Prevention. Attention
Deficit Hyperactivity Disorder. Available at
http://www.cdc.gov/ncbddd/adhd/index.html. Accessed September 9, 2016.
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