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Oxalate Control. Our primary effort is focused on our Oxalate Control business unit, and specifically the development of therapies for enteric hyperoxaluria secondary to Crohn's Disease and other malabsorption diseases, and recurrent kidney stones, and a number of other calcium oxalate-related conditions. Our therapies are based on our proprietary use of unique oxalate-degrading bacteria, where we have a very strong intellectual property position. Stem Cell / Diabetes. Our other business unit is focused on the development of human somatic cellular therapies to treat diabetes, based on selecting, proliferating, and directing the differentiation of adult pancreatic stem cells into insulin-producing islet preparations ("preps"). Our goal is to produce commercial quantities of these preps and be the first company in the world to treat diabetes by implanting adult stem cell-derived islet preparations into patients. We expect to make use of the well-established Edmonton Protocol, a procedure that has become the "gold standard" for islet transplantation for diabetes. In this area our initial product shall consist of allogeneic, cultured, functional islet preparations, derived in vitro from adult, pancreatic duct stem cells, which we call human Islet-Producing Stem Cells ("hIPSCs")-derived islets. We have established proof of principle that islet preps derived from IPSCs can reverse diabetes (published in the March 2000 issue of Nature Medicine) and have begun a large animal pilot study (which we expect to follow with pre-clinical toxicology studies in two species). Although there are many possible sources of tissue for the cellular treatment of diabetes, we believe that adult pancreatic duct stem cells present the shortest and least complicated path to the objective. A reviewer in a recent issue of the British Medical Journal has commented:
Out-licensing. We intend to out-license the diagnostic of our oxalate technology once development makes an out-license possible on attractive terms. We are pursuing several out-licensing opportunities for it.
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