Curis, Inc. (CRIS) – Class Leader in Advanced Basal Cell Carcinoma Treatment
Curis, Inc. had an outstanding 2011 starting with pivotal (suitable for regulatory submission) Phase II data reported for vismodegib for the treatment of advanced basal cell carcinoma (BCC) by collaborator Genentech (RHHBY.PK). The vismodegib trial met its primary endpoint by achieving a target overall response rate by shrinking advanced BCC tumors in a pre-defined percentage of people in the study. The safety profile was noted as being consistent with previous trials with few adverse reactions with long-term observations still underway. Curis’ pipeline is centered on attacking cancer via its signaling drug pathway technologies. Vismodegib’s action is based on regulating the Hedgehog signaling pathway. Aberrant Hedgehog signaling is implicated in more than 90 percent of BCC cases as well as many other cancers. An excellent overview of this specific signaling pathway and its implications in other cancers may be found here.
More detailed clinical data for vismodegib was first released in June and offers real hope to those suffering from the disease. Data indicated an overall response rate, as assessed by an independent review facility, showing vismodegib substantially shrank tumors or healed visible lesions with observed response rates for 43 percent of patients in the laBCC cohort (71 patients in which surgery would result in substantial physical deformity) and 30 percent of patients in the mBCC cohort (33 patients in which the BCC had metastasized). An additional notation in the data stated that there were no residual BCC cells in sampled biopsies of 54 percent of laBCC patients.
Genentech submitted the NDA in September and announced FDA acceptance of the NDA in November with a priority review of the application. A PDUFA date of March 8, 2012 was assigned to allow completion of the NDA review and potentially grant marketing approval of vismodegib. Curis received $8 million as a milestone payment from Genentech for the NDA acceptance and will receive additional milestone payments upon approval as well as royalty payments once the drug is marketed. In December, Genentech also announced they had submitted a Marketing Authorization Application to the European Medicines Agency for vismodegib. This application entitled Curis to an additional $6 million milestone payment. Additional milestone payments will be paid to Curis if the MAA is accepted and more royalties will be paid subsequently once the drug is marketed.
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