Addressing the Nutrient Deficiencies Associated with Autism Spectrum Disorders for both Children and Adults
Los Angeles, CA, December 23, 2013 — Targeted Medical Pharma, Inc. (OTCQB: TRGM), 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 to follow-up.
“The formulations used in the investigation are milligram amounts of precursors to neurotransmitters 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 indicate a significant alteration of amino acid concentrations demonstrating a specific need for nutritional management of the amino acid concentrations.”
“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 shortly.
About Targeted Medical Pharma, Inc.
Targeted 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 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.
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