Wellmune

EAGAN, MN — February 7, 2013 — Wellmune WGP^®, a natural immune health ingredient from Biothera, may help stressed women stay well, according to results of a new study just published in the Journal of the American College of Nutrition.

The study found that moderately to highly stressed women experienced fewer upper respiratory tract infection (URTI) symptoms and higher energy levels while taking Wellmune WGP, a functional ingredient in foods, beverages and supplements in more than 50 countries. At 12 weeks, there was a 58% reduction in URTI symptoms among women taking Wellmune. Click here for a link to the abstract.

Wellmune WGP, a baker’s yeast beta glucan, is clinically proven to safely boost the immune system to help keep the body healthy. Numerous peer-reviewed studies demonstrate that Wellmune WGP activates key innate immune cells that are part of the body’s natural defenses without stimulating the immune system.

Study Design and Results

Seventy-seven healthy women (age 38 + 12 yrs) pre-screened for moderate levels of psychological stress were given either a placebo or 250 mg of Wellmune WGP daily for 12 weeks.  Only 10% of the Wellmune group reported upper respiratory tract infection symptoms (sore throat, stuffy or runny nose, and cough) compared with 29% for the control group (p value ≤ 0.05).  In other words, the Wellmune group had a 58% reduction in reported URTI symptoms.

The study used the Profile of Mood States (POMS) psychological survey to assess changes in mental/physical energy levels (Vigor) and overall well-being (Global Mood State).  Vigor improved 41% in women taking Wellmune WGP compared with 7% in the control group (p value <0.05).  Similarly, the Global Mood State of women taking Wellmune improved 29% compared with 16% in the placebo group (p value <0.05).

“This is the first published study exploring the effects of Wellmune WGP on women, a population that arguably faces stressors,” Richard Mueller, chief executive officer, Biothera. “This is actionable information for women who are seeking more and better ways to keep pace with their daily lives.”

“Daily supplementation with Wellmune made a noticeable difference in maintaining health and a positive mental attitude among psychologically stressed women,” said Shawn Talbott, Ph.D., research director at SupplementWatch and lead investigator on the study. “The regimen resulted in reduced incidence of upper respiratory symptoms and improved psychological well being.”

About Wellmune WGP^®

Wellmune WGP is a proprietary baker’s yeast beta 1,3/1,6 glucan that is clinically proven to prime key immune cells that keep the body healthy. This natural food, beverage and supplement ingredient has regulatory approval around the world, including GRAS status in the U.S. and novel foods approval in Europe and China. Wellmune is available in more than 100 products in more than 50 countries around the world. It is also patented, Kosher, Halal, non-allergenic and GMO-free. In addition to receiving an IFT Innovation Award, Wellmune has received a SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
(651) 256-4606 (direct)
dwalsh@biothera.com

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Biothera is participating in BENEFIQ 2012, an international event focused on the commercial, scientific and regulatory aspects of the health ingredients sector scheduled for Sept. 25-27 in Quebec City. The program will include Biothera’s John Blocher, Ph.D. speaking on the topic of “Successful Immune Health Ingredient: A Case Study.”

Using Biothera’s Wellmune WGP^® as a case study, Dr. Blocher will provide an overview of published scientific information and limited unpublished data in four key areas: safety, mechanism of action, pre-clinical efficacy and human clinical data.

The conference and exhibition is an initiative of the Institute of Nutraceuticals and Functional Foods, the largest group of researchers in Canada dedicated entirely to the complex interactions between foods, food components, nutrition and health. For more information about BENEFIQ 2012 visit www.benefiq.ca.

Data presented at International Carbohydrate Symposium

EAGAN, MN — August 2, 2012 — Biothera researchers enhanced the biological activity of a fungal beta glucan by altering its molecular structure, confirming previous research demonstrating the link between branching and functionality, according to data presented last week at the International Carbohydrate Symposium in Madrid.

For the study, carbohydrate chemists at Biothera used scleroglucan, a fungal beta 1,3 glucan that is highly branched with single glucose molecules.  When the branching was reduced from 30% to 12%, the average molecular weight increased, indicating the formation of complex higher ordered structures.  The single helical structures aggregated into triple helical structures that significantly increased their biological activity.

“By changing the molecular structure, we were able to transform a relatively inactive fungal beta glucan into one with greater biological activity,” said Dan Conners, president of Biothera’s Pharmaceutical Group. “This research highlights Biothera’s expertise in carbohydrate chemistry and our unmatched knowledge of beta glucan biotechnology.”

“The data confirms our earlier studies demonstrating that structure matters and that not all beta glucans are created equal,” said Rich Mueller, president of Biothera’s Healthcare Group.  “Ingredient or product claims must be supported by research with that specific ingredient and strain and not borrowed research.”

The poster presented at the symposium was entitled, “Modification of a Beta Glucan Affects Aggregation Behavior and Biological Activity.”  Authors: Magee, A.S.; Langeslay, R.R.; Will, P.M.; Elmasry, N.A.; Danielson, M.E.  Abstract.

Previous Biothera research showing that subtle differences in the molecular structure of various beta 1,3/1,6 glucans can significantly affect their ability to enhance innate immune system responses was presented at the National Cancer Institute.

About Biothera, the immune health company

Biothera is a biotechnology company dedicated to improving immune health. The company is commercializing its unique technology platform through two business groups. Biothera’s Pharmaceutical Group is conducting multiple clinical trials for the development of a drug that mobilizes the innate immune system to fight most types of cancer. The company’s Healthcare Group is a leading provider of natural immune health ingredients for functional foods, beverages, dietary supplements, cosmetics and animal nutrition.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)
dwalsh@biothera.com

EAGAN, Minn., June 7, 2012 – A panel of experts from regulatory, scientific and industry vantage points will present their perspectives on the scientific evidence required to substantiate an immune health claim during the 2012 Institute of Food Technologists (IFT) Annual Meeting and Expo in Las Vegas on Wednesday, June 27. The session will examine both why it is difficult to develop credible science to support claims that are compelling to consumers and acceptable to regulatory agencies and potential solutions.

“Substantiating an Immune Health Claim: Three Perspectives” will feature the following speakers and topics:

• “Substantiating Immune Health Claims: Perspectives of Scientific/Regulatory Authorities in North America and Europe” —Lina Paulionis, M.Sc., MHSc, RD, senior scientific and regulatory consultant, Intertek Cantox’s Food and Nutrition Group.
• “Challenges in Defining Appropriate Immune Function Biomarkers” —Simin Nikbin Meydani, D.V.M, Ph.D., director of the Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University.
• “Designing a Claim Substantiation Research Program: An Industry Perspective” —Don Cox, Ph.D., senior vice president, Research & Development, Healthcare Group, Biothera.

“Finding the right combination of credible science to support claims and to meet the needs of stakeholders from regulatory agencies through product development and manufacturing to consumers is a significant challenge, especially given the complexity of the immune system and the rapidly evolving regulatory framework,” said Dr. Cox. “This session will illuminate key challenges from a global perspective in developing the scientific data to support a commercially viable and meaningful claim and provide best practices in claims substantiation.”

Two members of Biothera’s Healthcare R&D group are involved with this IFT symposium.  Biothera’s flagship immune health ingredient, Wellmune WGP^®, has earned broad regulatory approval as an immune health ingredient for foods, beverages and supplements. The clinically proven immune health benefits of Wellmune WGP have won accolades from the food and beverage industry including a prestigious IFT Innovation Award in 2007.

The session is from 10:35-11:35 a.m. in Room N117 at the Las Vegas Convention Center. For more information stop by the Biothera booth, #1829.

About Wellmune WGP^®

Wellmune WGP is a natural beta 1,3/1,6 gluco polysaccharide that is clinically proven to prime key immune cells that keep the body healthy. This unique food, beverage and supplement ingredient has regulatory approval around the world, including GRAS status in the U.S. and novel foods approval in Europe and China.  It is also patented, Kosher, Halal, non-allergenic and GMO-free. In addition to receiving an IFT Innovation Award, Wellmune has received a SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

 Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)

651-675-0300 (main)

dwalsh@biothera.com

Clinical research published in the British Journal of Nutrition

EAGAN, MN — May 21, 2012 — Wellmune WGP^®, a natural immune health ingredient for foods, beverages and supplements, prevented suppression of the immune system that normally occurs after intense exercise, according to a new clinical study published online in the British Journal of Nutrition.

These results, along with similar physical stress clinical studies, demonstrate that Wellmune WGP may help recreational and elite athletes achieve training and performance goals by minimizing “down time” associated with immune suppression.

“In contrast to the placebo group, athletes taking Wellmune had a higher degree of immune support before and after exercise, as measured by monocyte concentrations and enhanced cytokine production during a simulated immune challenge,” said Brian McFarlin, Ph.D., FACSM, Associate Professor of Exercise Physiology, Nutrition, and Immunology in the Department of Health and Human Performance at the University of Houston.

Wellmune WGP is a beta 1,3/1,6 gluco polysaccharide that boosts key innate immune cells that help keep the body healthy.  Specifically, Wellmune activates neutrophils, the most abundant population of immune cells in the body. It also enhances certain chemical messengers that help coordinate the body’s immune defenses.

Study Design

The randomized, double-blinded, placebo-controlled study involved 60 recreational athletes [31 women (age 22 +5), 29 men (age 23 +5)] engaged in sustained aerobic exercise. Following initial screening, study subjects were given either a placebo or 250 mg of Wellmune WGP daily for 10 days.

At the end of the supplementation period, the athletes rode an exercise bicycle for approximately 50-min in a heat stress chamber set at 38C (100F) and 45% relative humidity to create an environment that placed the athletes under physiological and psychological stress.  Blood samples were drawn at day 0 and immediately before and after the exercise session and again two hours post exercise. Twenty-five different aspects of immune health were analyzed.

Using a cross-over study design, the athletes next observed a seven-day “wash out” period during which no supplement was given to clear their bodies of any supplement effect. The study subjects then repeated the 10-day supplementation with the other test variable (Wellmune or placebo).  At the end of the second supplementation period, the subjects then replicated their initial exercise regimen.

Study Results

Study subjects taking Wellmune WGP had statistically significant higher concentrations of monocytes in their blood compared with the blood samples while taking the placebo.  The higher monocyte level was recorded immediately before and after exercise, as well as two hours post exercise.

Study participants also had higher levels of key cytokines (IL-2, IL-4, IL-5 and IFN-gamma) following a 24-h Lipopolysaccharide (LPS) stimulation when taking Wellmune WGP.  LPS is derived from gram-negative bacteria and used to mimic a foreign challenge to stimulate an immune response.  The data also showed higher levels of plasma cytokines (IL-4, IL-5, IL-7, IL-8, IL-10, and IFN-gamma) two hours after exercise when the subjects had supplemented with Wellmune.  All of these results were statistically significant (p<0.05).

The research was conducted under the direction of Dr. McFarlin at the Health and Human Performance Lab, University of Houston.  The paper, “Baker’s yeast β-glucan supplementation increases monocytes and cytokines post-exercise: implications for infection risk?” was published online ahead of print in the British Journal of Nutrition.  Authors: K. C. Carpenter, W. L. Breslin, T. Davidson, A. Adams and B. K. McFarlin.  Abstract.

About Wellmune WGP^®

Wellmune WGP is a natural beta 1,3/1,6 gluco polysaccharide that is clinically proven to boost key immune cells that help maintain health, wellness and vitality. This unique ingredient is found in more than 35 countries in food, beverage and supplement products, including juices, smoothies, toddler formula, soups, breads, beverage shots and sachets, and functional chocolates, cookies and snack bars.

Wellmune has regulatory approval around the world, including GRAS status in the U.S. and novel foods approval in Europe and China.  It is also patented, Kosher, Halal, non-allergenic and GMO-free.

In addition to receiving an IFT Innovation Award, Wellmune has received a SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)

651-675-0300 (main)

dwalsh@biothera.com

We love it when there are innovative new ways that consumers can easily enjoy the everyday immune health benefits of Wellmune WGP. In this case, Wellmune is now incorporated in a filter for the blue water bottle shown – or any bottle you choose. Talk about an effortless way to support immune health.

The folks at LiveWell were sold on the immune health clinical research behind Wellmune WGP and you’ll see that our logo is displayed on the filter’s packaging.

You can learn more about this novel delivery system in the following news release from LiveWell, a company committed to health, wellness and addressing safety issues for drinking water.

LiveWell™ introduces LiveHealthy Immune Support System with Wellmune WGP® for daily immune support

Boise, Idaho, 4/30/12-  LiveWell LLC is expanding the offerings in its LiveWell Healthy Hydration System to include the LiveHealthy with Immune Health Support System with Wellmune WGP®. LiveWell Healthy Hydration Systems enable consumers to enjoy clean, enhanced, filtered water while on the go and without the cost and waste of bottled water.

The all-natural Wellmune WGP immune health ingredient is clinically proven to safely prime the immune system to keep the body healthy. Numerous peer-reviewed, published studies demonstrate that Wellmune WGP mobilizes billions of innate immune cells that are part of the body’s natural defenses without over stimulating the immune system. LiveHealthy with Immune Health Support comes in a choice of Lemon Lime or Orange Creamsicle flavors. The filters can be used on specially designed LiveHealthy water bottles or on almost any bottled water. As with all LiveWell systems, they are BPA free and biodegradable.

The Livewell system was first developed by a youth soccer coach who wanted his kids to hydrate with safe, healthy water instead of popular sports drinks loaded with sugar and artificial ingredients.

“LiveWell understands that consumers are seeking new, effective vitamin delivery forms that are easy to use and provide benefits for immune support,” said Rick Anson, CEO, LiveWell. “We chose WellmuneWGP^® as our core immunity ingredient because of the science backing its health benefits.”

“Busy families now have the convenience of filtration, hydration and clinically proven immune support right at hand with the introduction of the LiveHealthy with Immune Support hydration system,” said Rich Mueller, president and CEO, Biothera. “It’s easy to use and a novel delivery system to reap the everyday benefits of Wellmune WGP.”

Wellmune WGP is patented, Generally Recognized As Safe (GRAS) under U.S. FDA regulations, Kosher, Halal, non-allergenic and GMO-free.

For more information on LiveHealthy with Wellmune WGP, please visit www.livewellwater.com and www.wellmune.com.

About LiveWell™

LiveWell LLC is committed to consumer’s health and wellness, addressing safety issues for drinking water, and becoming the industry leader in eco-efficient products that are as environmentally and economically sustainable as possible.

About Wellmune WGP^®

Wellmune WGP is a natural carbohydrate that is clinically proven to prime key immune cells that keep the body healthy. This unique food, beverage and supplement ingredient is Generally Recognized as Safe (GRAS) under U.S. FDA regulations. It is also patented, Kosher, Halal, non-allergenic and GMO-free. The ingredient is a recipient of an IFT Innovation Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

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Elaine Watson of Nutraingredients-USA.com caught up with Rich Mueller, Biothera healthcare group president, to discuss the challenges manufacturers face to support immune health claims. Mueller noted that using vitamins and minerals is not enough and that it takes ingredients based on numerous clinical studies demonstrating the direct correlation between a specific ingredient strain and the immune health benefit. The story also included mention of Praeventia Cookies with Wellmune WGP from Biothera now available at 500 Walmart stores.  Biothera” ‘Using vitamins and minerals alone to support immune claims is not enough’

EAGAN, MN — February 27, 2012 — The EU is investing 6M Euros in an international research project evaluating the immune health effects of Wellmune WGP® and several other functional food ingredients.

The FibeBiotics project is a consortium of four European universities, five research institutions and several private companies that will study the effect of food fibers on the human immune system. Wageningen UR Food & Biobased Research, The Netherlands, is coordinating the 4.5-year project.

Wellmune WGP is gluco polysaccharide that is clinically proven to safely prime key immune cells that help keep the body healthy. Derived from a proprietary strain of yeast, Wellmune WGP mobilizes neutrophils, which are the largest population of immune cells in the body and part of the body’s first line of defense.

“We are pleased that Wellmune WGP is part of this important scientific research project,” said Rich Mueller, Biothera president and chief executive officer. “It will be complementary to our internal research program that is designed to expand understanding of our unique technology and its global immune health benefits.”

According to a FibeBiotics statement: “It is known for a long time that polysaccharides (other than easy digestible starch) and the immune system are connected. The immune response towards invading pathogens like bacteria, fungi and yeast is often initiated by the recognition of the intruder via the sugar chains that are located on the outside of the pathogen. After this recognition the immune system is activated and attempts to remove the pathogen as fast as possible.

“Research indicated that some specific polysaccharides, for example those from the cell wall of yeast or those that are present in various plant products, can activate the immune system starting from the intestine, even when no intruders are present. Various polysaccharides have been shown to activate macrophages, which can ‘digest’ pathogens and unwanted cells. An activated, warned or primed first layer of defence can help to improve the overall resistance of humans.”

About Biothera
Biothera is a U.S. biotechnology company dedicated to improving immune health. It manufactures and markets patented, natural ingredients for functional foods, beverages and nutritional supplements worldwide. Its flagship ingredient, Wellmune WGP, is the culmination of more than $300 million in research with leading university and government institutions. Wellmune WGP is formulated in food, beverage and supplement products in more than 35 countries. It has broad regulatory approval worldwide including GRAS status in the U.S. and novel foods approval in Europe and China. Wellmune is a recipient of an IFT Innovation Award, a 2011 SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606
dwalsh@biothera.com

When LovetoKnow.com asked celebrity fitness and nutrition expert JJ Virgin, from TLC’s Freaky Eaters, to share some of her favorite tips – we were pleased to see Wellmune  WGP® ranked high on her list. The interview, which was actually on how to exercise for weight loss and keep the pounds off through exercise and nutrition, included JJ’s suggestions for people who have tried many different diet and exercise programs, and still have difficulty losing weight.

You can’t get a great workout if you aren’t well, and JJ pointed out that Wellmune WGP works to keep you healthy by mobilizing billions of innate immune cells that are part of your body’s natural defenses. “It helps maintain energy, vitality and mental clarity when you are stressed,” she added.

JJ didn’t mention that a recent clinical study at the University of Houston demonstrated that Wellmune WGP reduced immune suppression that normally occurs following high intensity exercise.  This means that both recreational and elite athletes may be able to work out hard and longer without lowering their immunity.

Biothera Analytical Methods Adopted for New Industry Standard

EAGAN, MN — September 8, 2011 — The United States Pharmacopeia (USP), in collaboration with Biothera, has developed the first official monograph for beta glucan from bakers yeast (Saccharomyces Cerevisiae), a natural food, beverage and dietary supplement ingredient widely recognized for its immune health benefits.

The monograph was recently issued in the Third Supplement of the Seventh Edition of the Food Chemicals Codex, an internationally recognized compendium of standards for the purity and identity of food ingredients.

Biothera is a biotechnology company dedicated to improving immune health.  The company manufactures Wellmune WGP^®, a proprietary bakers yeast beta glucan clinically proven to prime key immune cells that help keep the body healthy and vital.  Biothera contributed the reference standard and two methods for identifying and quantifying the beta 1,3/1,6 branched glucan polymer derived from the cell walls of bakers yeast.