Thomas Kieber-Emmons, PHD, University of Arkansas for Medical Sciences, Clinical Translation Research Award:

Most of the vaccine type of talks are always talking about targeting protein antigens that are expressed on tumor cells. We're one of the few people who talk about the expression of carbohydrate antigens.

We went from looking at antibodies and how they bind to carbohydrates on the surface of tumor cells to realizing that we can trick the immune system into inducing antibodies and t-cells that will see carbohydrates express on tumor cells.

We think we have a different way of manipulating the response so that we can get the type of response that we're looking for, primarily, because carbohydrates are not processed the same way as proteins are or peptides are. So it's a little more complicated for people, it's a little more daunting, a little more challenging. Can you synthesis these carbohydrates? Can you purify these carbohydrates? So, I think historically it's just been more complicated. And because of that not many researchers, unfortunately, are spending time looking at carbohydrates or glycans.

We had shown previously that we can induce immune responses targeting carbohydrates on breast tumor models as well as other model types in animals, both in the therapeutic setting as well as the prophylactics setting. Now we are getting ready to vaccinate our first set of pioneers. When we think of women who volunteer for clinical trials, we think of them as pioneers. So, hopefully we will be immunizing our first pioneer come April or May of 2009.

Our Phase 1 trial will have, depending on what we see in the Phase 1, anywhere between 9 and 18 pioneers will be immunized. And in our Phase 2 we are looking at between 44 and 56 pioneers. So we think at the end of 3 years we'll have a pretty good sense of whether or not this is really a viable approach to induce sustained immunity to these carbohydrates, and then it will probably take a number of years after that for Phase 3 testing.