Curis expects that the FDA will notify Genentech whether its NDA submission has been accepted for filing within 60 days of submission, and if it is accepted, the agency will communicate to Genentech its targeted action date under the Prescription Drug User Fee Act (PDUFA) to complete its review of the NDA and potentially grant marketing approval of vismodegib.
Roche has also indicated that the timing of a European regulatory submission is subject to its ongoing discussions with the European Medicines Agency (EMA). Curis is entitled to receive an additional milestone payment should such submission be made by Roche and subsequently accepted by the EMA, as well a milestone payment and royalties on future sales should vismodegib be approved by the EMA.
-- Dosed First Patient in Phase I CUDC-101 Head and Neck Cancer Combination Trial
In August, Curis announced that the first patient was treated in a Phase I clinical trial that is designed to test CUDC-101 when administered concurrently with cisplatin and radiation in human papillomavirus negative (HPV-) locally advanced head and neck cancer patients. CUDC-101 is a first-in-class small molecule drug candidate that has been designed as an inhibitor of epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (Her2) and histone deacetylase (HDAC).The Phase I clinical trial is designed as an open-label, dose escalation study in which a total of approximately 12-25 HPV- locally advanced head and neck cancer patients will be treated with CUDC-101 in combination with cisplatin and radiation at 3-4 study centers in the United States. The primary objective of this study is to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101 in this patient population. Secondary objectives are to (i) evaluate the efficacy of CUDC-101, cisplatin and radiation therapy in combination, (ii) assess the pharmacokinetics of CUDC-101, and (iii) evaluate tumor markers for response associated with CUDC-101, cisplatin and radiation activity. CUDC-101 will be administered three times per week for 8 consecutive weeks, with a beginning dose of 225 milligrams per meter 2. The MTD of CUDC-101 in a previously completed single agent Phase I clinical trial was established as 275 milligrams per meter 2. -- Curis, Inc. Appoints Robert Martell, M.D., Ph.D. to its Board of Directors In September, Curis announced the appointment of Robert Martell, M.D., Ph.D., to its Board of Directors. Dr. Martell is currently the Director of the Neely Center for Clinical Cancer Research and the Leader of the Program in Experimental Therapeutics at the Tufts Medical Center Cancer Center as well as an Associate Professor of Medicine at the Tufts University School of Medicine. Previously, Dr. Martell served as Vice President and Chief Medical Officer of MethylGene, a publicly-traded biotechnology company focused on the development of cancer therapeutics, and as Director of Oncology Global Clinical Research at Bristol-Myers Squibb Company, where he worked with molecular-targeted drugs in areas such as multi-target kinase inhibitors (including the panHER inhibitor program), CDK2 inhibitor and was closely involved in the Biologic Licensing Application (BLA) for Erbitux, an antibody that targets EGFR.