Targeted
Medical Pharma, Inc. (OTCQB: TRGM) today announced that the company
will begin a clinical trial on a new medical food indicated for the
dietary management of Autism and Autism Spectrum Disorders.
This open label trial will measure the changes in blood concentrations
of specific amino acids, behavior, mood, and sleep patterns over a
thirty day period following a twice daily oral administration of the
company’s new medical food. Subjects will be screened for enrollment
based on medical history and diagnosis of Autism or any Autism Spectrum
Disorders.
“Autism and Autistic Spectrum have long been recognized to be associated
with reduced absorption of amino acids and a decrease in several brain
neurotransmitters. With our targeted cellular technology platform, we
believe that this product may be able to increase the concentration of
the necessary amino acid precursors and brain neurotransmitters that are
diminished in patients with autism,” said David Silver, M.D., President
and Chief Operating Officer at Targeted Medical Pharma, Inc. “Our
company has established that treating an underlying nutritional
deficiency of a disease with a medical food can greatly reduce symptoms
and improve clinical outcomes.”
Autism and Autism Spectrum Disorders affect one percent of the
population of children in the U.S. ages three to seventeen, with an
estimated prevalence of one out of eighty eight births in the U.S. being
affected by the disease. The current pharmacologic treatments available
are ineffective at treating the disease and are often associated with
adverse side effects.
About Targeted Cellular Technology
Targeted cellular technology is a patented five-step process that is the
foundation for the company’s medical foods. This technology promotes the
rapid cellular uptake, conversion and release of neurotransmitter
precursors, prevents attenuation and increases the efficacy of milligram
quantities of amino acids, nutrients and biogenic amines.
About Targeted Medical Pharma, Inc.
Targeted
Medical Pharma, Inc. is a Los Angeles-based biotechnology company
that develops prescription medical
foods for the treatment of chronic disease, including pain
syndromes, peripheral neuropathy, hypertension, obesity, sleep and
cognitive disorders. The company manufactures 10 proprietary
prescription-only medical foods, as well as 48 convenience packed kits,
which pair a medical food and branded or generic pharmaceutical. These
prescription medical foods and therapeutic systems are sold to
physicians and pharmacies in the U.S. through the company’s subsidiary, Physician
Therapeutics. These proprietary medications represent a novel
approach to the management of certain disease states, focusing on safety
and efficacy without the deleterious side effects of traditional, high
dose prescription drugs. The company also is developing nutrient-based
systems for oral stimulation of progenitor stem cells that differentiate
into neurons, red blood cells, pituitary hormones including IGF-I.
Targeted Medical Pharma also is engaged in the development of a
proprietary line of dietary supplements.
Forward Looking Statement
This press release may contain forward-looking statements related to
Targeted Medical Pharma’s business strategy, outlook, objectives, plans,
intentions or goals. The words "may," "will," "should," "plans,"
"explores," "expects," "anticipates," "continue," "estimate," "project,"
"intend," and similar expressions, identify forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995, but their absence does not mean that the statement is not
forward-looking. These statements are not guarantees of future
performance and are subject to certain risks, uncertainties, and
assumptions that are difficult to predict. Actual results could differ
materially. Targeted Medical Pharma expressly disclaim any obligation or
undertaking to update or revise any forward-looking statement contained
herein to reflect any change in the company's expectations with regard
thereto or any change in events, conditions or circumstances upon which
any statement is based.
Copyright Business Wire 2013