Study to Examine the Use of Theramine for the Treatment of Acute or Sub-Acute Lower Back Pain due to Injury
Los Angeles, CA, July 28, 2014 — Targeted Medical Pharma, Inc. (OTCQB: TRGM), today announced the completion of an agreement to sponsor an investigator-initiated study with the United States Army and The Henry M. Jackson Foundation for the Advancement of Military Medicine Inc. (HJF). The study, which is slated to start enrolling patients in Q2 of 2014, will involve the Company’s medical food Theramine.
The placebo-controlled study will seek to enroll 128 patients with acute or sub-acute lower back pain caused by injury. The principal investigator is an employee of the U.S. government and is the Director of Research, Department of Anesthesiology at Womack Army Medical Center Fort Bragg NC. The study is projected to be completed within 18 months from the first patient enrollment. Upon completion, the Foundation and the Principal Investigator will have the first opportunity to publish the results of the study whether or not the study results are favorable.
“We are excited to work with the HJF and the United States Army to further establish the efficacy of Theramine for the treatment of low back pain,” said William Shell M.D., Chief Executive Officer and Chief Science Officer at Targeted Medical Pharma. “Theramine has previously been established in two double-blind, multi-center trials to be effective at improving chronic low back pain, and has been in clinical use for over a decade. Sponsoring this trial provides our Company with a unique opportunity to service the men and women of the United States Military, providing them a safe and non-addictive option for pain management.”
About The Henry M. Jackson Foundation for the Advancement of Military Medicine
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. is a global organization dedicated to advancing military medical research. The Foundation serves military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.
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 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.
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