Safety of Wellmune

Interviewer:  You talked about safety a little bit but can you talk a little bit more about the safety of Wellmune, is this something we can take every day and still be OK for us?

Dr. Donald Cox:  Sure.  Another area I enjoy talking about because safety is very important to something that's going to be consumed on a daily basis.  It's very important...let's talk about safety from a couple of angles.  First let's talk about product composition.  If I'm going to take a product day in and day out I want to know the composition.  I want it well defined.  In the case of Wellmune there's one active ingredient.  It's the beta 1316 glucan that is isolated from the cell wall of baker's yeast.  And as we say Wellmune is guaranteed minimum of 75% and typically runs quite a bit higher in that concentration.  That's very important because a known composition gives you something to study in safety and toxicology studies. Very important with respect to toxicology that the right studies are conducted. Typically before an ingredient is used and declared safe you want to run what are called sub chronic toxicity studies.  And sub chronic toxicity studies means that in a particular model, research model, that you're feeding this for at least 90 days.  And observing the effects of various levels of the material on the overall health of the research model.  We did this several times with Wellmune at concentrations up to 1000 times the standard dose and found that Wellmune was very well tolerated and very safe for the research models, the animal models that we used in our research publications.  So back in 2007 we published this data in food and chemical toxicology.  And I think an important side point to make with respect to the research at Biothera is everything gets published.  Everything from our safety data, mechanism of action, preclinical and clinical data we have quite a portfolio of published research.  And that adds to the second aspect of the safety of Wellmune.  Of course it's demonstrated and published in typical toxicology models but we also naturally monitor the safety of Wellmune in all of our human studies.  That's a very important aspect in terms of understanding the safety of the ingredient and demonstrating it long term.

Interviewer: And along with that talk a little bit more about the research that supports the health benefits of Wellmune.

Dr. Donald Cox:  Sure.  Wellmune is very well researched.  We've published now nine different studies and we've actually conducted a number of additional studies beyond that.  We often will do small pilot scale studies with just a small number of human studies to help...human subjects excuse me, we often conduct our studies with just a small number of human subjects so that we can model or understand how best to design our studies.  So our studies have demonstrated consistent benefits in helping to maintain overall physical health.  As we spoke earlier there's a whole range of events that occur in our daily lives. From pollution and outward stress that we experience to typical health challenges such as cold and flu that we experience and encounter routinely and having a strong immune system is your best defense against a lot of these potential health issues.  With Wellmune we have used a lot of clinically valid models for demonstrating that we maintain physical heath.  That during periods of high physical or lifestyle stress that we also help to maintain the health of the subjects in the studies.  Using physical stress first as an example.  We have several published studies where we've looked at high physical stress.  Some of these are more rigorous in terms of physical stress such as marathon studies of which we have two publications.  Another one we've used exercise stress and looked at various immune bio markers and consistently in these different model we're able to demonstrate that Wellmune helps to maintain phys8ical health.  Helps the subjects to recover their physical health after a marathon, let's say, when you have significant stress on your respiratory track. And also in particular models where we have physical stress of an intensive nature such as some of the exercise stress models that we've used.  We've demonstrated that Wellmune helps certain immune cell parameters recover more rapidly than for subjects on the placebo.  And if we take a different route, not everybody is a marathon runner of course.  If we take a slightly different route and we talk about common lifestyle stress.   Well let's talk about some careers where there's combinations of physical and lifestyle stress.  We have conducted and published a study with, for example, medical students.  We did this study at Southampton University in the UK.  And there we saw improvements in maintenance of overall physical health over a 90 day period where subjects obviously we under high physical and lifestyle stress.  They're working long hours, they're around sick people because they're in a hospital environment and they maintain their health...all the way to another type of study.  We did a study probably five years ago with firefighters.  There were wildfire firefighters.  Subjects, people who go out and fight forest fires in the western part of the United States and they're off for several weeks at a time in the wilderness and what we saw with that study was that the subjects maintained the physical health and had better overall feelings of health than did subjects in the placebo groups.  And then lastly when we just take the common lifestyle stress that we all experience.  Recently we've published a study looking at the overall lifestyle stress of women.  And how women with moderate to high lifestyle stress how we're able to maintain their health better.  They had better feeling and better energetic feelings and fewer symptoms of cold or flu were noted.  In the study.  For those subjects that took Wellmune than those that are on placebos.  So overall there's a range of clinical studies that have been published that demonstrate the health benefits of Wellmune.  Secondly there's a long term commitment to continuing to generate clinical research and publications that support Wellmune.  We conduct anywhere between two and four clinical studies depending on the complexity and the cost of course to help further support the benefits of Wellmune for those people that are interested in consuming it.