|[December 19, 2013]
Targeted Medical Pharma Reports Initial Results from a Clinical Observation of Medical Foods for Children and Adults with Autistic Spectrum Disorder Symptoms
LOS ANGELES --(Business Wire)--
Medical Pharma, Inc. (OTCQB: TRGM), today announced additional
preliminary findings from an investigator initiated clinical observation
of amino acid based medical
foods to address specific
nutrient deficiencies in children and young adults with autism
spectrum disease (ASD) symptoms.
34 subjects including 29 children and 5 young adults ages seven to
twenty-one who were diagnosed with ASD or suffering from related
symptoms including explosive behavior, social isolation, and mood
disorder were treated with an amino acid based formulation for one to
several months. The investigators reported that 33 of the subjects were
initial responders and demonstrated significant improvement with regards
to decreased disruptive outbursts, improved socialization, improved mood
and reduction in drug dose. Patients with explosive outbursts improved
an average of 83 percent compared to baseline. The five adults reported
improved mood and reduction of anxiety from 50% to 90% and in one case a
100% reduction in symptoms of mania. The investigators caution that the
sample for adults is small and that an additional four cases were lost
"The formulations used in the investigation are milligram amounts of
precursors to neurotrasmitters using a proprietary technology protected
by several patents," said William Shell, M.D., CEO and Chief Science
Officer of Targeted Medical Pharma. "Autism affects the way patients
metabolize certain nutrients and we believe that our medical food
technology is a safe and effective way to increase amino acid and
neurotransmitter levels for both children and adults. A key target of
the formulation is the glutamine/glutamate access which is known to be
disrupted in autistic spectrum disease patients. Measurement of amino
acid concentrations in plasma and cerebrospinal fluid indicates a
significant alteration of amino acid concentrations demonstrating a
specific need for nutritional management of the amino acid
"The current pharmacologic treatments available for this patient
population do not address the specific nutrient deficiencies, and are
associated with a host of negative side effects," said David Silver,
M.D., President and Chief Operating Officer at Targeted Medical Pharma.
"The initial results from this observation show that the symptoms of
Autism in children and young adults can potentially be improved by
addressing the specific nutritional deficiencies of the disease. The
amino acids used in the study are considered generally recognized as
safe (GRAS) and no significant side effects were observed."
A double-blind randomized placebo controlled trial will be initiated
About Targeted Medical Pharma, Inc.
Medical Pharma, Inc. is a Los Angeles-based biotechnology company
that develops medical
foods for the treatment of chronic disease, including pain
syndromes, peripheral neuropathy, hypertension, obesity, sleep and
cognitive disorders. The company also develops a line of dietary
supplements designed to support health and wellness. The company
manufactures 10 proprietary medical foods, and recently launched its
first dietary supplement, Clearwayz™.
The products are sold directly to physicians and pharmacies in the U.S.
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.
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 disclaims 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.
[ Back To Technology News's Homepage ]