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.
Copyright Business Wire 2014