Curis InitiatesRoche-Sponsored Phase 1b/2 Study of Erivedge in Relapsed/Refractory AML and High Risk MDS

Curis

, an oncology-focused company developing novel drug candidates for the treatment of human cancers, today announced that Roche

initiated a Phase 1b/2 study of Erivedge® (vismodegib) in patients with relapsed/ refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS). Roche and its wholly-owned subsidiary, Genentech, have developed Erivedge under a collaboration agreement with Curis. Aberrant activation of the Hedgehog signaling pathway has been reported to play a role in the development of certain cancers including basal cell carcinoma (BCC) and AML. Erivedge is an oral drug designed to block abnormal Hedgehog pathway signaling, and has been approved for the treatment of advanced basal cell carcinoma (aBCC) in the US, Europe and a number of other countries. The current Phase 1b/2 clinical trial is designed to examine the potential benefit from Erivedge treatment for AML and MDS cancer patients. It is believed that selective targeting and blocking of the Hedgehog signaling pathway may have an effect on leukemic (stem) cell proliferation and survival. "We are extremely pleased with Roche's commitment to the continued development of Erivedge for treatment of patients with cancers where the Hedgehog pathway appears to be altered,"