Curis, Inc. (Nasdaq:CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, has announced that two publications describing clinical data generated with Erivedge(TM) (vismodegib, GDC-0449) capsule were published in the current edition of The New England Journal of Medicine (NEJM).
The first publication, entitled "Efficacy and Safety of Vismodegib in Advanced Basal Cell Carcinoma," reports on the results of the pivotal Phase II ERIVANCE BCC study in 104 patients with advanced basal cell carcinoma (BCC) conducted by Genentech. The second publication, entitled "Inhibiting the Hedgehog Pathway in Patients with Basal-Cell Nevus Syndrome," reports on results from an investigator-sponsored study evaluating the potential of Erivedge in 41 patients with basal cell nevus syndrome (BCNS) and surgically eligible BCCs.
Erivedge is a first-in-class oral medicine designed to selectively inhibit signaling in the Hedgehog pathway. It is also is the only FDA-approved medicine for patients with advanced BCC. There are currently no approved medicines for advanced BCC outside the United States. Erivedge is being developed by Roche and Genentech, under a collaboration agreement between Curis and Genentech, a member of the Roche Group.
"The published ERIVANCE BCC study results provide further evidence supporting the FDA approval of Erivedge for advanced BCC patients," said Dan Passeri, Curis President and Chief Executive Officer. "Efforts are also ongoing to learn more about the potential of Erivedge in patients with BCNS with surgically eligible BCCs, where recent data have demonstrated an important proof-of-concept of Erivedge efficacy in this disease. In addition, Genentech is currently conducting a Phase II clinical trial in operable BCC and an investigator-sponsored Phase II study is planned to investigate Erivedge as a pre-surgical treatment for BCC."
Mr. Passeri continued, "In addition to the ongoing clinical development efforts in BCC, Roche has filed regulatory submissions for the approval of Erivedge in advanced BCC in Europe, Australia, Canada and Switzerland, potentially expanding patient access to Erivedge."
ERIVANCE BCC Publication
The advanced BCC data reported in the NEJM publication were from a multicenter, international, two-cohort, nonrandomized Phase II study that formed the basis of the FDA approval for Erivedge. The overall response rate in the pivotal study as assessed by an independent...