We believe that potential successful Immunotherapies may be developed by eradicating or simply reducing the tolerizing effects of tumors. Therefore, we are actively engaged in the pre-clinical and clinical development of small molecule drugs that act as inhibitors of the IDO enzyme. Pre-clinical data has demonstrated that IDO inhibitors have potent anti-tumor effects in combination with chemotherapeutic drugs and with other adjuvant Immunotherapies such as CpG oligodeoxynucleotides.

The ability to acutely deprive these tumors of the protective IDO mechanism, by administering IDO inhibitors drugs such as 1MT may provide a therapeutic window in which to break tolerance to tumor antigens. Fortunately, from a pharmacological standpoint, drugs that inhibit IDO, such as 1-methyl-D-Tryptophan seem to inhibit IDO activity in both tumor cells and host APC’s.

We have identified 1-methyl-tryptophan (1MT) as our first drug candidate to complete toxicology and pharmacological testing with appropriate characteristics for clinical applications.  We intend to submit an Investigational New Drug (IND) application and initiate clinical trials with this exciting novel compound during the 2nd half of 2006 or early 2007.  Additionally, we are focused in our efforts to identify new IDO inhibitors and study their anti-tumor activity in animal models, as a standalone treatment or in combination with chemotherapeutic agents, tumor vaccines, and other potential adjuvants.