Curis announces start of Roche-sponsored study of Erivedge for AML and MDS
by Jeffrey Bouley  |  Email the author


LEXINGTON, Mass.—Oct. 4 saw Curis Inc., an oncology-focused company, announce that Roche initiated a Phase Ib/II 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 and AML. Erivedge is an oral drug designed to block abnormal Hedgehog pathway signaling, and already has been approved for the treatment of advanced basal cell carcinoma in the United States, Europe and a number of other countries. The current Phase Ib/II clinical trial is designed to examine the potential benefit from Erivedge treatment for AML and MDS cancer patients. The companies involved believe 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 Dr. Ali Fattaey, Curis' president and CEO. "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. "  
According to Roche, the open-label, non-randomized clinical study is expected to enroll approximately 60 patients into two cohorts. Patients in one cohort will receive 150 milligrams of Erivedge alone once daily, and patients in the other cohort 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 eight 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).  
Roche has developed Erivedge under a collaboration agreement with Curis. Erivedge was discovered by Genentech and jointly validated by Genentech and Curis through a series of preclinical studies. Through this collaboration, Genentech in the United States, Roche outside the United States (excluding Japan) and Chugai Pharmaceuticals (in Japan) are responsible for the clinical development and commercialization of Erivedge. Curis is eligible to receive cash payments assuming the successful achievement of specified clinical development and regulatory approval milestones, as well as royalties upon commercialization of Erivedge.  
In January 2012, Erivedge became the first licensed medicine for patients with advanced basal cell carcinoma when the U.S. Food and Drug Administration (FDA) approved it following a priority review. Erivedge has since also been approved in other countries, including Australia, Canada, Ecuador, European Union, Norway, Israel, Mexico, South Korea, Switzerland and Uruguay.  
SOURCE: Curis news release

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