Bakers Yeast Beta-Glucan

Transcription

1 Bakers Yeast Beta-Glucan Wellmune Science March 2015

2 2 Introducing Bakers Yeast Beta-Glucan Beta 1,3/1,6 Glucan 100% natural, gluten-free ingredient Clinically proven to help strengthen the immune system Safe for everyday consumption A global & reputable brand with broad regulatory approvals

3 3 Validated Science Dozens of peer-reviewed published studies on technology

4 4 The proof is in our clinical results Unmatched clinical results support Wellmune s effectiveness: Powerful & Consistent Results Improves overall physical health Reduces upper respiratory symptoms Reduces harmful effects of stress Enhances vigor and mental clarity Reduces fatigue Amongst a Broad Range of Consumers Numerous published, clinical studies 1. Texas Marathon Runners 2. California Marathon Runners 3. Exercise Induced Stress 4. Medical Students 5. Lifestyle Stress (90 days) 6. Lifestyle Stress (28 days) 7. Allergy Sufferers 8. Cold/Flu Sufferers 9. Firefighters* 10. Southampton Aging Population* * Publication pending

5 What is bakers yeast betaglucan (BYBG)?

6 6 Health benefits begin with structure b (1-3)-linked Branch CH 2 OH CH 2 OH O O OH HO OH CH 2 OH ( CH 2 OH ) O O HO n CH 2 OH OH CH 2 b (1-6) Branch point CH 2 OH O O O O O O O O O O HO OH HO OH HO OH HO OH HO OH b (1-3)-linked Backbone

7 7 BYBG is sourced from Proprietary Strain of Yeast (Saccharomyces cerevisiae) Yeast Cell Mannoprotein Beta 1,3/1,6 Glucan Beta 1,3/1,6 Glucan Lipids, Proteins, Nucleic Acids and cellular contents Yeast Cell Cross Section Fibrillar Layer Mannoprotein Beta 1,3/1,6 Glucan Mannoprotein Plasma Membrane Cytoplasm. Lipids

8 Mechanism of Action

9 Technology Background Immunology Discoveries Dr. Gordon Ross, Brown Cancer Center Deputy Editor-Journal of Immunology Dr. Ross s research in the 1980s: How does the body clear a yeast or fungal infection? Neutrophil responsible for killing yeast and fungal challenges. Specific receptor (Complement Receptor 3 or CR3) on the surface of neutrophils that triggered killing. CR3 requires a specific carbohydrate and complement to initiate killing.

10 Immune Response to Yeast / Fungus Yeast or Fungus ic3b 1. Natural antibody binds to yeast and activates complement 2. Complement (ic3b) binds (fixes) to target yeast and attracts immune cells Complement Receptor 3 ic3b ic3b β1,3/1,6 Glucan 3. Neutrophil binds to the complement (via CR3) and to the β1,3/1,6 Glucan on the surface of the yeast at the same time which triggers a CR3-mediated killing mechanism. Neutrophil

11 Wellmune BYBG Priming of Neutrophils Wellmune WGP binds to CR3 on neutrophil priming the immune cell for activity Neutrophil

12 Wellmune BYBG Priming of Neutrophils Target: Foreign Challenge ic3b ic3b ic3b 4. Primed neutrophil binds to complement on target via CR3 which activates CR3-mediated killing mechanism. Primed Neutrophil

13 How does Wellmune BYBG work? Consumed orally, Wellmune is taken up into the body via the Peyer s Patches in the intestines. Immune cells called macrophages that now contain Wellmune travel to the immune organs throughout the body. These macrophages break down Wellmune into smaller fragments that bind to neutrophils, the most abundant immune cells in the body. Primed by Wellmune, neutrophils more quickly recognize and kill foreign challenges. 13 Hong et al. (2004) J. Immunol. 173,

14 Clinical Research

15 Wellmune Clinical Studies Study Name Presented Published 1) Texas Marathon 2012 American Soc. of Sports Medicine Journal of Dietary Supplements, ) Exercise Stress 3) Medical Students 4) Lifestyle Stress 90-day 5) Lifestyle Stress 28-day 2011 Int l Society of Exercise Immunology British Journal of Nutrition, British Society of Immunology Nutrition, Experimental Biology J. of American College of Nutrition, American College of Nutrition Agro Foods Industry Hi Tech, ) Allergy 2011 Experimental Biology Food Science & Nutrition, ) California Marathon 2007 American College of Nutrition J. of Sports Science & Medicine, ) Cold/Flu 2008 Experimental Biology Journal of Applied Research, ) Firefighters 2008 American Soc. of Sports Medicine Pending 10) Aging Population 2013 Southampton Translational Clinical Research Conference Pending

16 16 Wellmune clinical studies Our health benefit studies include nearly 1,700 adults & children. 971 healthy normal adults: Physical stress studies (311) Psychological stress studies (372) Other studies (188) Senior population (100) 706 healthy children, ages 1-4: Mead Johnson studies Biothera children s study

17 Wellmune clinical studies # of Studies Reduction in URTI Symptoms* = 9 Adult 2 Children Wellmune Physical & Psychological Health Benefits Improvement in POMS scores = 3 Adult URTI = Upper Respiratory Tract Infection POMS = Profile of Mood States Reduction in Allergy Symptoms = 1 Adult 1 Children * Reduction is # subjects or days 17

18 Exercise Stress Studies

19 The Impact of High Intensity Exercise J-curve Hypothesis: URTI incidence drops as exercise intensity increases until it reaches an inflection point and begins to increase as exercise intensity increases from moderate to severe. 19 Figure adapted from Nieman DC, Johanssen LM, Lee JW. Infectious episodes in runners before and after a roadrace. J Sports Med Phys Fitness. 1989;29(3): Copyright 1989BMJ Publishing Group Ltd.]

20 Exercise Stress/Biomarker Study The Study Protocol 60 recreationally fit adults 29 male/31 female (23± 5 yr) Cross over design, double-blind, randomized Open Window Effect Many immune biomarkers show a quick drop that lasts for 2-6 hours following exercise. 250 mg Wellmune dose Cycling at 100 F (38 C) for approximately 1 hour (2 sessions) Blood and saliva samples at: Day zero (baseline) Day 10 pre-exercise Day 10 post-exercise (2 hours) 20 Study model developed at University of Houston Dept. of Health & Human Performance. Br J Nutr May 10:1-9

21 Total Monocytes X 10 3 / ml Key Immune Cells: Monocytes Total Monocyte Concentration * *Significantly p< 0.05 Placebo Wellmune WGP Baseline Pre Post 2h Wellmune significantly reduced the effect of exercise on circulating monocytes.

22 Salivary IgA (pg/ml) Mucosal Immunity Salivary IgA * Placebo WGP Baseline Pre Post 2h *Significantly p< 0.05 Wellmune improved salivary IgA recovery at two hours post-exercise.

23 IL-4 (pg / ml) LPS-Stimulated Cytokines LPS Stimulated Cytokines : IL * * * Baseline Pre Post 2h *Significantly p< 0.05 The change demonstrates Wellmune s ability to enhance immune responses to a perceived challenge.

24 24 Exercise Stress/Biomarker Study Biomarker data supports athletic performance benefits. Maintained white blood cell levels Wellmune prevented the drop in white blood cells that can occur following intense exercise Improved mucosal immunity Wellmune helped salivary IgA levels rebound more quickly after exercise IgA, a protective protein is associated w/ improved immune protection of the mucosa Enhanced immune responses to a simulated challenge The Wellmune group had higher levels of key cytokines following lipopolysaccharide (LPS) stimulation

25 Exercise Stress/Biomarker Study Healthy Zone Challenge zone Placebo

26 Exercise Stress/Biomarker Study The Study Protocol Double-blind, crossover design with sedentary young men and women (19-35 y) completing two conditions (betaglucan and placebo) in a random, counterbalanced order. Open Window Effect Many immune biomarkers show a quick drop that lasts for 2-6 hours following exercise. 250 mg Wellmune or placebo dose for 10 days Exercise stress: Intervals of treadmill walking (8-min; MPH) and jogging (7-min; MPH) totaling 90-min of exercise Blood and saliva samples at: Day zero (baseline) Day 10 pre-exercise Day 10 post-exercise (2& 4 hours) 26 Study model developed at University of Houston Dept. of Health & Human Performance. Br J Nutr May 10:1-9

27 27 Mucosal immunity (siga) Placebo

28 28 Why BYBG? Objective biomarker evidence of efficacy Significant portfolio of clinical results (proven safe & effective) Strong published scientific support including mechanism of action, safety data, pre-clinical and clinical data

29 Questions?