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Curis Announces Initiation Of A Roche-Sponsored Phase 1b/2 Study Of Erivedge(R) (vismodegib) In Relapsed/Refractory AML And High Risk MDS

LEXINGTON, Mass., Oct. 4, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), 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," said Ali Fattaey, Ph.D., Curis' President and Chief Operating Officer. "We believe that inhibition of Hedgehog pathway signaling by Erivedge has the potential to provide benefit for patients with AML and MDS. Specifically, unlike basal cell carcinomas that are driven by mutations in the Hedgehog pathway, AML and MDS represent cancers where ligand-dependent abnormal signaling within this pathway is associated with the disease."

About the Phase 1b/2 AML/MDS study:

The Phase 1b/2 study is designed to investigate the safety and efficacy of Erivedge in patients with relapsed/ refractory AML or relapsed/refractory high risk MDS. According to Roche, the open-label, non-randomized study is expected to enroll approximately 60 patients into two cohorts. Patients in Cohort 1 will receive 150 milligrams of Erivedge alone once daily, and patients in Cohort 2 will receive the same dose of Erivedge once daily in combination with the standard dose of cytarabine administered for 10 days. The primary endpoint of the trial is the overall response rate after 8 weeks of treatment. The secondary endpoints include overall response rate at any time during treatment, duration of response, overall survival, and safety and pharmacokinetics of the study drug(s). For additional details of the study, please refer to (study identifier: NCT01880437).

About Erivedge

Erivedge is designed to selectively target the Hedgehog signaling pathway, which is implicated in the development of certain types of cancer, including basal cell carcinoma (BCC).

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