Stemina Biomarker Discovery Launches Largest Ever Clinical Study of Metabolism of Children with Autism

MADISON, Wis.–(BUSINESS WIRE)–Stemina Biomarker Discovery Inc. today announced the launch of the
largest clinical study of the metabolism of children with autism
spectrum disorder (ASD) ever conducted. The Children’s Autism Metabolome
Project or “CAMP” study will enroll 1,500 subjects from six sites across
the country. CAMP will attempt to confirm that sets of metabolic
biomarkers can detect subtypes of ASD. This new study is an expanded
version of Stemina’s three pilot studies of more than 500 children. CAMP
is also designed to contribute to identification of new biomarkers with
the goal of advancing a panel of tests for earlier diagnosis and more
precise treatment of ASD based on the metabolism of patients.

Metabolomics is the study of differences in a person’s metabolism as
genomics is the study of differences in a person’s genes. Metabolomics
focuses on identifying normal and abnormal patterns of small molecules
which indicate the presence of illness. Altered metabolism of patients
offers more insight into the individual patient and potential treatments
that may be effective based on the patient’s own metabolism. Stemina’s
proprietary metabolomics technology is capable of identifying not only
biomarkers associated with disease, but also metabolite patterns
associated with toxicology and cellular response to drugs or chemicals
this may be used in future studies to try to identify environmental
factors associated with autism and other neurological disorders.

Stemina announced that it has received a $2.7 million grant from the
National Institute of Mental Health (NIMH) to support CAMP. The study is
also supported by a $2.3 million investment from the Nancy Lurie Marks
Family Foundation (NLMFF). Children are being enrolled at the MIND
Institute at the University of California – Davis, Arkansas Children’s
Hospital Research Institute in Little Rock, Vanderbilt University in
Nashville, Cincinnati Children’s Hospital, Nationwide Children’s
Hospital in Columbus, and the Melmed Center in Phoenix. CAMP requires
the enrollment of 500 children with autism, 500 with other
neurodevelopmental disorders without autism and 500 typically developing
children in the 18 to 48 month age range.

The research has the potential to enable earlier diagnosis and
individualized treatment of children with ASD from a small blood sample.
Stemina has conducted three independent proof-of-concept studies with
more than 500 patients with ASD from the MIND Institute and Arkansas
Children’s Hospital Research Institute. The first study was published in
PLOS One in November with collaborators from the MIND Institute.

(See: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0112445)

“We are excited about participating in CAMP and continuing our work with
Stemina. Confirmation of findings from our previous two pilot studies
would be an important step towards developing an early diagnostic marker
of ASD. Metabolomics may be the key to detecting clinically meaningful
subtypes of autism,” said Dr. David Amaral, Distinguished Professor of
Psychiatry and Research Director of Research of the MIND Institute at UC
Davis. “Autism is a very complex disorder, really a series of disorders.
CAMP has the potential to deliver some important diagnostic tools as
well as to increase our understanding of these subtypes of autism from a
metabolic perspective. Earlier diagnosis can lead to earlier
intervention resulting in the most effective reduction of symptom
severity.”

Diagnosis of ASD at an early age is important for initiating the most
effective intervention. Today, behavioral therapy is the standard of
care for children with ASD. It is important that intervention begin as
early as possible to achieve optimal outcome. Patients can be reliably
diagnosed through behavioral testing at age 2 at health care facilities
with expertise in diagnosing autism and yet the average age of diagnosis
according to the Centers for Disease Control is 4½ years. Stemina’s goal
is to significantly reduce the average age of diagnosis through a
diagnostic panel of metabolic biomarkers being refined through the CAMP
study. This will offer both improved and earlier diagnosis as well as
the potential for individualized therapy and better outcomes for
patients and their families.

“Stemina’s proprietary metabolomics platform technology will
revolutionize the way ASD is diagnosed and treated,” said Elizabeth
Donley, Chief Executive Officer of Stemina. “Autism is a spectrum
disorder from a cognitive and behavioral perspective. Stemina’s work is
demonstrating that it is also a spectrum disorder from a metabolism
perspective. By diagnosing ASD based on the patient’s metabolism, we
hope to understand what is different about the metabolism of children
with ASD and each subtype compared to typically developing children.
This approach will open up a whole new frontier for understanding the
disorder and how to treat it.”

About Stemina Biomarker Discovery:

Stemina Biomarker Discovery was founded in 2007 and is located in
Madison, Wisconsin. Stemina is a biomarker discovery company focused on
diagnosis and individualized treatment of neurological disorders
including autism spectrum disorders. Stemina uses its proprietary
metabolomics platform to identify changes in metabolism that can be
biomarkers more effective diagnosis and treatment of autism and other
neurological disorders. Stemina operates its business in two divisions:
one focused on developing diagnostic tests for neurological disorders;
and the other focused on screening chemicals and compounds for their
potential to cause birth defects if a woman is exposed during pregnancy.
Clients include pharmaceutical, chemical, cosmetics and consumer
products companies, the U.S. Army and the Environmental Protection
Agency.

Visit Stemina on the web at www.stemina.com.

About the Nancy Lurie Marks Family Foundation

The primary mission of the Nancy Lurie Marks Family Foundation (NLMFF)
is to help people with autism lead fulfilling and rewarding lives. The
foundation is committed to understanding autism from a scientific
perspective, increasing opportunities and services available to the
autism community and educating the public about autism. In pursuit of
its mission, the foundation develops and provides grants to programs in
research, clinical care, policy, advocacy and education.

For more information on the Nancy Lurie Marks Family Foundation, visit: http://www.nlmfoundation.org/about_nlm.aspx

Contacts

Stemina Biomarker Discovery
Elizabeth Donley, (608)577-9209
Chief
Executive Officer
bdonley@stemina.com