Wellmune

Robust Clinical Research Program Resulting in Proven Health Benefits Cited

EAGAN, MN –May 21, 2013 – Wellmune WGP^®, the natural immune health ingredient for foods, beverages and supplements from Biothera, was awarded “Outstanding Application in Health Management” during the recent NBT Awards event at Vitafoods Europe in Geneva.

The winning entry focused on the rigorous peer-reviewed, published clinical research program for Wellmune that is unmatched by any other immune support ingredient available for functional foods and nutraceuticals. It conclusively demonstrates substantial scientific support for a health claim, based upon establishing a reproducible physical health benefit and correlating biomarkers.

“To win in a popular category, you have to present something outstanding,” said Kevin Robinson, head judge, NBT Awards. “Out of the shortlisted finalists, Biothera’s nomination was the most convincing, offering clear and substantial benefits, strong, peer-reviewed evidence and good quality science.”

“We are gratified to receive this award in recognition of the proven health benefits that Wellmune can bring to a broad range of consumers through functional foods and nutraceuticals,” said Richard G. Mueller, CEO, Biothera. Mueller noted that Wellmune is ideal for boosting immunity every day year round and supports a wide range of immune health needs including year-round immune support, stress management, athletic performance, and energy and vitality.

“With our sole focus on immune health ingredients, Biothera is in a unique position to generate the data necessary to validate an immune health claim, having both the internal research expertise and collaborative research partnerships needed for a program of this magnitude,” added Mueller. The program has resulted in broad regulatory approval worldwide and a wider range of use occasions than is typical for immune boosting ingredients.

The NBT Awards program recognizes and rewards excellence in R&D, marketing, business and technology throughout the nutraceutical, functional food and beverage industry. The mission is to deliver a set of benchmarks to a global audience to achieve significant developments in quality of service, health management, research, development and relationship management. The awards program is held annually during Vitafoods Europe.

About Wellmune WGP^®
Wellmune WGP is a proprietary baker’s yeast beta 1,3/1,6 glucan that is clinically proven to boost 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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In anticipation of his presentation as part of the Preventative Health and Immunity session at Vitafoods Europe in May, Biothera’s Don Cox, Ph.D., senior vice president, Healthcare Group R&D, Biothera, offers 10 tips for evaluating immune health ingredients. For more information on the program visit http://www.vitafoods.eu.com/conference.

Dietary interventions to support immune health are bringing new excitement to the food and beverage industry. Here are 10 factors to consider when evaluating immune health ingredients:

1. Ingredient safety: Ensure that the ingredient has safety data published in a peer-reviewed toxicology journal and reviewed by EFSA (EU), the US FDA and/or other leading regulatory agencies. Request and review the government’s regulatory letters.
2. Mechanism of action: Studies should be conducted in a manner that demonstrates the mechanism of action as measured by its effect on the innate or acquired immune system. Independent, peer-reviewed, published research is best.
3. Method of boosting: Some immune boosters provide temporary stimulation and create an artificial and unnatural state that may damage the body if taken too long. Others safely boost the body’s natural immune mechanisms to respond to a challenge, maintain immune system balance and can be taken year-round.
4. Quality and quantity of the clinical research: Look for multiple peer-reviewed, published, high quality studies with consistent outcomes. Peer-reviewed, double-blinded, placebo-controlled clinical studies are the gold standard.
5. Research source: Examine whether the research was conducted with the specific ingredient or borrowed from other products. Borrowed science is junk science. The specific biological strain or chemical structure matters.
6. Study design: Design is important to eliminate unintentional bias. Understand and weigh the merits of single blind, open label, double blind, and crossover study designs. While all are valid designs, double-blind studies and crossover design eliminate data variations owing to the physical make up of each treatment group.
7. Outcomes employed: The major forms of outcomes of scientific and regulatory interest are biomarker outcomes and physical health outcomes. Many outcomes can be misinterpreted or are surrogates for the clinical endpoint. Outcomes in human clinical studies must have a demonstrable positive benefit for humans.  Outcome selection is not always clear cut.
8. Ingredient characterization: The health benefit activity must be attributed to known component(s) with well defined molecular structure.  Characterization allows for measurement and standardization required for establishing serving recommendations, consistency in manufacturing and stability and shelf-life testing. Identifying the active component is necessary for determining the desired health effect; it also provides confidence that the efficacy or stability is the same from batch to batch.
9. Serving size determination: Ensure that the ingredient’s dose-response data supports the recommended daily serving. A demonstration of dose response is the best indicator of optimum or effective serving.
10. Formulation characteristics: No matter how safe or effective the ingredient, it is essential that it can be formulated into foods and beverages so that the ingredient doesn’t break down and lose its potency if exposed to heat, pH or pressure required in the manufacturing process.  It is critical that appropriate analytical methods be available to quantify the amount of the ingredient present in the food or beverage after processing and at the end of the projected shelf life of the product.

Dr. Philip Calder

As part of our ongoing commitment to increase understanding of the link between nutrition and immune health, we are pleased to make available an archive of the first in a series of continuing education modules for dietitians! The webinar, presented by Philip Calder, BSc (Hons), PhD, DPhil, RNutr, Professor of Nutritional Immunology, University of Southampton Faculty of Medicine) was hosted by the Dietiitans in Integrative an Functional Medicine Dietetic Practice Group of the Academy of Nutrition and Dietetics.

This one-hour webinar explored the immune system, a complex system of cells and tissues that protects the human body from invading pathogens. Dr. Calder, a leading nutritional immunologist, highlighted the growing body of clinical understanding about the role that good nutrition plays in immune health throughout the lifecycle, and the importance of immune health to overall health and well being. He shared the latest clinical insights on enhancing immune function and conclude with several examples of novel dietary immune interventions.

Click here for a link to the webinar.

Click here for more about Dr. Calder.

At 12 weeks, there was a 58% reduction in upper respiratory tract infection symptoms

EAGAN, MN — February 7, 2013 — Wellmune WGP^®, a natural immune health ingredient from Biothera, may help stressed women maintain protection against the symptoms of colds, flu and stressors of everyday life, according to results of a new study just published in the Journal of the American College of Nutrition. Click here for a link to the abstract. 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.

Wellmune WGP, a baker’s yeast beta glucan, is clinically proven to safely prime the immune system to keep the body healthy. Numerous peer-reviewed studies demonstrate that Wellmune WGP mobilizes billions of 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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EAGAN, MN – January 14, 2013 – Wellmune WGP^®, the clinically proven natural immune health ingredient from Biothera, is now available in a drinkable yogurt product from Grupo Gloria, the largest commercial dairy company in Peru. Initial distribution is planned to retail locations across the country including supermarkets and convenience stores.

Gloria’s Pro Defensis marries the clinically proven systemic immune health benefits of Wellmune WGP with the gut health benefits of probiotics. It is the first-ever yogurt to combine these clinically proven benefits.

“Yogurt is an everyday, mainstream food product making it an ideal delivery system for the daily immune support that Wellmune WGP provides,” said Richard Mueller, CEO, Biothera. “We’re gratified that working closely with Gloria and our distributor Quimtia, yogurt now joins the wide range of applications for the proven immune health benefits of Wellmune WGP.”

Pro Defensis is available in vanilla and strawberry flavors. Each bottle delivers 100 mg of Wellmune. The recommended daily serving is 2.5 mg/kilo of body weight.

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.

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Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)
651-675-0300 (main)
dwalsh@biothera.com

EAGAN, MN, January 2, 2013—Wellmune WGP, a natural immune health ingredient for foods, beverages and supplements, reduced allergy symptoms and improved the quality of life of ragweed allergy sufferers according to clinical results published online in the peer-reviewed journal Food Science & Nutrition. Click here for a link to the abstract.

An estimated 40 to 50 million Americans are affected by allergies, with ragweed a leading cause of seasonal allergy symptoms including nasal congestion, sneezing, itchy eyes and difficulty breathing. Allergy symptoms are caused by an immune system overreaction to ragweed pollen.

The placebo-controlled, double-blinded study of 48 healthy people who were subjected to high pollen counts demonstrated statistically significant (p<0.05):

• Reductions in overall symptoms and severity

• Reductions in key nasal and eye-related allergy symptoms

• Improvement on the Quality of Life Index, a scientifically validated tool for measuring how participants rate their overall sense of wellness.

Wellmune, a proprietary baker’s yeast beta glucan, mobilizes billions of innate immune cells that are part of the body’s natural defenses without over-stimulating the immune system. In this study, Wellmune was found to modulate the immune system when less of an immune response was needed.

The results of this study are consistent with numerous previous peer-reviewed, published studies demonstrating that Wellmune can safely prime the immune system to keep the body healthy.

“The findings suggest that Wellmune WGP can play an effective role in reducing seasonal allergy symptoms among ragweed allergy sufferers,” said Shawn M. Talbott, Ph.D., lead investigator, GLH Nutrition, LLC. “While these results are encouraging, additional studies including more study participants should be conducted.”

“A daily regimen including all-natural Wellmune WGP is well-documented to safely support immune health, a key contributor to overall health and well-being,” said Richard Mueller, chief executive officer, Biothera. “Given the important role immune modulation plays in managing symptoms, allergy sufferers who choose foods, beverages and supplements with clinically proven immune support can help ease their discomfort during allergy season.”

Study Design

The randomized, placebo-controlled, double-blind study included self-described “moderate” ragweed allergy sufferers. Forty-eight healthy subjects were equally divided 48 healthy subjects (31 female, 17 male; 39± 13 years of age) into two groups. One group consumed a placebo while the other a 250 mg serving of Wellmune WGP daily for four weeks during September/October 2011 in an area of southeast Ohio with high pollen counts. Participants completed allergy surveys including the validated Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) to assess differences in allergy symptoms.

The research was funded by Biothera, Inc.

About Wellmune WGP^®

Wellmune WGP is a natural yeast beta 1,3/1,6 glucan 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

Immune health was on the menu at the Dietitians in Integrative and Functional Medicine breakfast during the Food and Nutrition Conference and Expo in Philadelphia on October 8.  The featured speaker at the Biothera-sponsored event was Roger Clemens, DrPH, past president of the Institute of Food Technology. In this short video Dr. Clemens recaps the key points he made in this presentation to a packed hall of dietitians, focusing on what the immune system is, the role of nutrition in immune health and what is involved in immune function.

For more about immune health and nutrition resources for dietitians click here.

A recent story posted on SheKnows.com highlighted “Power Foods That Help Guard Your Health.” We were happy to see a section on immune support and even happier to see that Wellmune was included in the story as a great choice for enhancing the immune system without over-stimulating it.

As author Felicia D. Stoler, DCN, MS, RD, FACSM pointedly notes, “Grocery shopping today is like going on a treasure hunt. You can either load your cart with things that fill you up but don’t do much to keep you healthy, or you can reach for everyday superfoods that support your well being.”

She goes on to say, “Foods and drinks fortified with the right nutrients can help your immune system function at its peak and reduce a cold’s symptoms.” That’s a good reminder of the importance of everyday immune support as we approach cold and flu season. Click here to read the full story. How many of these superfoods are in your shopping cart?

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.

In a recent column in Food Technology, Roger Clemens, Dr. P.H., Institute of Food Technologies president, discussed the rising global obesity epidemic and the opportunities and challenges to overcoming this serious public health crisis. He commented on the need to consider several overlooked factors contributing to diabetes and related diseases, including a person’s immune health. Drawing on remarks by Dr. Jose Saavedra, a speaker at IFT’s recent 2012 Annual Meeting and Food Expo in Las Vegas, Clemens wrote:

Everything consumers eat has a direct effect on their immunological response and metabolism, Dr. (Jose) Saavedra said. He asserted that a healthy immune system is just as important as lifestyle choices and dietary intake in the fight against obesity-related non-communicable diseases. Diabetes, allergies, celiac disease and other intestinal disorders are but a few of the manifestations of a poor diet and ill-prepared immune system.

Preferences for salty, sugary, and fatty foods that begin early in life tend to persist throughout one’s lifespan, so if healthy dietary choices and a strong immune system are not established early, consumers are less likely to develop them later.

Clemens advocated a future that integrates food, nutrition, medicine, and public health and policy to support a healthy lifestyle throughout the lifecycle.

This perspective on the importance of a healthy immune system in the fight against obesity is an enlightening addition to the discussion about health and wellness. It’s another reminder of the health benefits of Wellmune WGP for everyone in the family.