Curis is developing targeted small molecule drug candidates for cancer indications where there are substantial unmet therapeutic needs.
The Hedgehog pathway inhibitor ErivedgeŽ (vismodegib) developed from our most advanced program, and is being commercialized in collaboration with Genentech/Roche. Genentech and Roche are responsible for the clinical development and commercialization of Erivedge. Erivedge is currently approved for use in patients with advanced basal cell carcinoma in the United States, European Union, Australia, Canada and several other countries. Erivedge is also under regulatory review for marketing authorization in several other territories and is also being studied in patients with less severe forms of basal cell carcinoma. There are several additional Phase I and II clinical trials ongoing under a collaboration between Genentech and independent investigators and the National Cancer Institute.
We have focused most of our internal resources on developing novel, proprietary small molecule targeted cancer drug candidates. Our most advanced, clinical-stage small molecule drug candidates for the treatment of various cancers include a dual phosphoinositide 3-kinase (PI3K) and histonedeacetylase (HDAC) inhibitor, CUDC-907 and an antagonist of inhibitor of apoptosis (IAP) proteins, CUDC-427. CUDC-427 was placed on a partial clinical hold by the FDA on November 5, 2013, under which new patients may not be treated with CUDC-427 until the FDA lifts the hold. Curis expects to provide additional data and an amended protocol to the FDA. We also have an EGFR/Her2 and HDAC inhibitor, CUDC-101, in preclinical development.
Our second development candidate under collaboration is Debio 0932, an HSP90 inhibitor that Curis licensed to Debiopharm Group in August 2009, and is currently the subject of a Phase I/II trial in advanced non-small cell lung cancer. Debiopharm recently completed a Phase Ib clinical trial with Debio 0932 in solid tumors, including patients with non-small cell lung cancer. Debiopharm also plans to initiate an additional clinical trial during the second half of 2013 to investigate Debio 0932 in advanced renal cell carcinoma patients.
Because of the early stages of development of most these programs, our ability and that of our collaborators and licensors to successfully complete preclinical and clinical studies of these product candidates, and the timing of completion of such programs, is highly uncertain.