VAL-083 represents a "first-in-class" small molecule chemotherapeutic, which means that the molecular structure of VAL-083 is not an analogue or derivative of other small molecule chemotherapeutics approved for the treatment of cancer.
VAL-083 has been assessed in 42 Phase 1 and Phase 2 clinical trials sponsored by the U.S. National Cancer Institute ("NCI") as a treatment against various cancers. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers.
VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia ("CML") and lung cancer. VAL-083 has not been approved for any indication outside of China.