Targeted Medical Pharma Initiates Clinical Trial of Red Blood Cell Stimulating Formulation
Medical Food Designed to Address the Increased Nutritional Requirements of Anemia
Los Angeles, CA (PRWEB) September 04, 2013
Targeted Medical Pharma, Inc. (OTCQB: TRGM), today announced the company has initiated a third open-label clinical trial of its oral amino acid-based erythropoietin stimulating system (ESS) to determine increased red blood cell production in subjects diagnosed with anemia of chronic disease.
The study consists of 30 patients randomized for treatment across multiple independent sites to measure the changes in blood values after the oral administration of the company’s ESS medical food. Primary outcomes of the trial include measuring hemoglobin concentrations and hematocrit percentages, as well as calculating patients’ red blood cell counts, reticulocyte counts and IGF-1 (insulin-like growth factor) protein levels. Subjects will be screened for enrollment based on medical history and diagnosis of anemia of chronic disease or anemia of inflammatory response.
“Earlier pilot studies of our oral ESS medical food showed a significant stimulation of progenitor stem cells, resulting in an increase in hemoglobin content in patients with chronic anemia,” said William Shell, M.D., CEO and Chief Science Officer of Targeted Medical Pharma, Inc. “Addressing specific nutrient deficiencies in this patient population with this targeted oral therapy may help promote the production of red blood cells and could potentially help the millions of people in the United States suffering from chronic and inflammatory diseases that affect erythrocyte production.”
Chronic anemia is a blood disorder that slows the production of red blood cells in the bone marrow. Various chronic infections, inflammatory diseases and other illnesses and medications can affect the body's ability to produce red blood cells. Some of these chronic conditions include certain cancers, autoimmune diseases such as rheumatoid arthritis, as well as HIV/AIDS, hepatitis C, liver disease and heart failure. Various symptoms of chronic anemia include fatigue and loss of energy, irregular heartbeat and shortness of breath, headaches, difficulty concentrating, dizziness and insomnia.
Targeted Medical Pharma recently announced results of an earlier pilot study that showed subjects diagnosed with mild to moderate anemia who were treated with the company’s ESS medical food increased their hemoglobin levels by an average of 11.39 percent. The average baseline hemoglobin measurement was 10.08 and 11.21 after 45 days with a similar increase in reticulocyte count (p<0.01).
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.
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