LifeVantage Announces Two Human Clinical Trials Investigating the Effects of Protandim(R) on Diseases Affecting the Liver and Lungs
SAN DIEGO, Jan. 5 /PRNewswire-FirstCall/ -- LifeVantage Corporation (OTC Bulletin Board: LFVN), the maker of Protandim® and TrueScience(TM) Anti-Aging Cream, science-based solutions to oxidative stress, announced today that the Company's flagship product, Protandim, a patented dietary supplement composed of five highly synergistic "indirect antioxidants", is currently the subject of two human clinical trials at the University of Colorado, Denver. The studies, entitled The Effect of the Dietary Supplement Protandim on Non-Alcoholic Steatohepatitis: A Randomized, Double Blind, Placebo-Controlled Study and Double Blinded Placebo Controlled Trial of Protandim for Individuals With a History of Alcohol Abuse respectively, began enrolling patients earlier this year and are currently on-going. These two trials are now listed in the Clinical Trials Database, a registry of federally and privately supported clinical trials conducted in the United States and around the world. The database is provided as a service of the U.S. National Institutes of Health and is available for public access at www.clinicaltrials.gov.
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The Effect of the Dietary Supplement Protandim on Non-Alcoholic Steatohepatitis: A Randomized, Double Blind, Placebo-Controlled Study
This independent clinical study is investigating the effects of Protandim on Non-alcoholic Steatohepatitis ("NASH"). Patient recruitment in this study has begun and is by invitation only.
According to the National Institutes of Health ("NIH"), NASH is a common, often "silent" liver disease. It resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and damage. Most people with NASH feel well and are not aware that they have a liver problem. Nevertheless, NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to work properly.
The study investigators hypothesize that Protandim could lead to an improvement in NASH when compared to placebo, could lead to decreases in serum markers of oxidative stress and liver chemistry tests, and lastly, could lead to decreased levels of tumor necrosis factor-alpha ("TNF-a") when compared to placebo. In NASH, TNF-a is hypothesized to be responsible for apoptotic cell death and inflammation, which characterize the disease. Dysregulation of TNF-a production has been implicated in a variety of human diseases.
The study investigators believe that their findings could lead to a better understanding of the role of oxidative stress and antioxidant therapy in NASH and may ultimately help improve patient care.
Double Blinded Placebo Controlled Trial of Protandim for Individuals With a History of Alcohol Abuse
This independent clinical study aims to determine the safety and efficacy of Protandim on alveolar-capillary barrier function in individuals with a history of chronic alcohol abuse. Patient enrollment in this study has begun and is currently open.
Alcohol abuse has been associated with the development of Acute Respiratory Distress Syndrome ("ARDS"), a disorder characterized by abnormal alveolar-capillary permeability. According to study investigators, ARDS affects approximately 150,000 patients per year in the United States, with a mortality rate of 40-50% even in previously healthy individuals.
The study investigators believe that further investigations of the association between chronic alcohol abuse and ARDS are needed to develop therapies that improve morbidity and mortality in this patient population.
The study investigators hypothesize that antioxidant deficiency, and, in particular, glutathione (GSH) deficiency, is a cause of abnormal alveolar-capillary barrier function in individuals with a history of chronic alcohol abuse. They further hypothesize that oral therapy with Protandim, which induces the antioxidant enzymes, including those that synthesize, utilize, and recycle GSH, could help to correct this abnormality.
More information about both of these studies can be found on www.clinicaltrials.gov.
About Protandim
Protandim is a clinically proven supplement that provides substantial benefits for healthy aging. This patented indirect antioxidant therapy works in a very different way than conventional foods such as red wine, oranges, blueberries or other popular antioxidant supplements. Unlike those types of products that have proven to be largely ineffective in reducing oxidative stress caused by free radicals, Protandim is an indirect antioxidant therapy, which stimulates the body's production of its own powerful antioxidant enzymes. Protandim works at the cellular level, triggering cells to naturally increase production of protective antioxidant enzymes such as superoxide dismutase (SOD), catalase, and glutathione synthase.
A peer-reviewed human clinical study showed that after Protandim was taken for 30 consecutive days, important biochemical markers of aging were decreased by an average of 40%. The study also reported that these markers of aging were reduced in the subjects taking Protandim to the level of a typical 20 year old. Protandim is currently the subject of approximately 20 scientific studies at universities and research facilities. The nature and stages of the studies vary.
Under the Dietary Supplement Health and Education Act, Protandim is considered a "dietary supplement" and, as with all dietary supplements, Protandim is not intended for the prevention, diagnosis, treatment, mitigation or cure of any disease. For more information about Protandim, visit www.LifeVantage.com.
About LifeVantage Corporation
LifeVantage Corporation is a publicly traded (OTCBB: LFVN), science-based, nutraceutical company dedicated to helping people reach their health and wellness goals. Founded in 2003 and based in San Diego, CA, LifeVantage develops products, including Protandim®, that are intended to deliver significant health benefits to consumers. For more information, visit www.LifeVantage.com.
Forward Looking Statements
This document contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believe," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Such forward-looking statements are not guarantees of performance and the Company's actual results could differ materially from those contained in such statements. These forward-looking statements are based on the Company's current expectations and beliefs concerning future events affecting the Company and involve known and unknown risks and uncertainties that may cause the Company's actual results or outcomes to be materially different from those anticipated and discussed herein. These risks and uncertainties include, among others, the potential failure or unintended negative consequences of the implementation of the Company's network marketing sales channel; the Company's ability to retain independent distributors or to attract new independent distributors on an ongoing basis; the potential for third party and governmental actions involving the Company's network marketing sales channel; the potential for product liability claims against the Company; the risk that government regulators and regulations could adversely affect the Company's business; future laws or regulations may hinder or prohibit the production or sale of the Company's existing product and any future products; unfavorable publicity could materially hurt the Company's business; and the Company's ability to protect its intellectual property rights and the value of its product. These and other risk factors are discussed in greater detail in the Company's Annual Report on Form 10-K and its Quarterly Report on Form 10-Q under the caption "Risk Factors", and in other documents filed by the Company from time to time with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this document, except as required by law.
Investor Relations Contact:
Ioana C. Hone
(858) 312-8000 Ext. 4
SOURCE LifeVantage Corporation
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