AML and MDS Represent Non-Mutation Driven Hedgehog Pathway Malignancies
LEXINGTON, MA, USA I October 4, 2013 I Curis, Inc. (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(R) (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 www.clinicaltrials.gov (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).
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 (U.S.), Roche (ex-U.S. excluding Japan) and Chugai Pharmaceuticals (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.
About Acute Myeloid Leukemia (AML)
AML is the most common acute leukemia in adults, accounting for approximately 25% of all leukemias in adults in the Western world with the highest incidence in the U.S., Australia and Western Europe. Approximately 14,500 new cases and more than 10,000 deaths from the disease are expected in the U.S. in 2013 according to the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) research data.
About Curis, Inc.
Curis is an oncology-focused company seeking to develop novel drug candidates for the treatment of human cancers. Erivedge is the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma and is being commercialized by Roche and Genentech, a member of the Roche Group, under a collaboration agreement between Curis and Genentech. Curis is also seeking to further the development of its pipeline of proprietary targeted cancer drug candidates, including CUDC-427, a small molecule antagonist of IAP proteins, and CUDC-907, a dual PI3K and HDAC inhibitor. For more information, visit Curis’ website at www.curis.com.
SOURCE: Curis
Post Views: 42
AML and MDS Represent Non-Mutation Driven Hedgehog Pathway Malignancies
LEXINGTON, MA, USA I October 4, 2013 I Curis, Inc. (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(R) (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 www.clinicaltrials.gov (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).
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 (U.S.), Roche (ex-U.S. excluding Japan) and Chugai Pharmaceuticals (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.
About Acute Myeloid Leukemia (AML)
AML is the most common acute leukemia in adults, accounting for approximately 25% of all leukemias in adults in the Western world with the highest incidence in the U.S., Australia and Western Europe. Approximately 14,500 new cases and more than 10,000 deaths from the disease are expected in the U.S. in 2013 according to the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) research data.
About Curis, Inc.
Curis is an oncology-focused company seeking to develop novel drug candidates for the treatment of human cancers. Erivedge is the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma and is being commercialized by Roche and Genentech, a member of the Roche Group, under a collaboration agreement between Curis and Genentech. Curis is also seeking to further the development of its pipeline of proprietary targeted cancer drug candidates, including CUDC-427, a small molecule antagonist of IAP proteins, and CUDC-907, a dual PI3K and HDAC inhibitor. For more information, visit Curis’ website at www.curis.com.
SOURCE: Curis
Post Views: 42
