Delcath (NSDQ:DCTH) said yesterday the company reached a special protocol assessment agreement with the FDA for the design of a Phase III trial of its Delcath Hepatic Delivery System and Melphalan Hydrochloride.
The system is designed to treat patients with hepatic dominant ocular melanoma, the New York City-based company said. The company said the agreement acted as a stamp of approval for the trial, and if objectives in the trial are met, it would support the submission for regulatory approval with the FDA.
“This agreement marks a major milestone for Delcath. Under this SPA our new Focus trial, if successful, will provide a clear pathway to an indication in hepatic dominant ocular melanoma for Melphalan/HDS. Additionally, through the dedicated work of our team and in close collaboration with the FDA, we have satisfied a substantial number of the requirements of the FDA’s 2013 CRL. Based on our commercial experience in Europe, the continued support and enthusiasm from key opinion leaders and the clinical data that have been presented and published recently, we have confidence that our Focus trial can demonstrate the efficacy and safety necessary for a positive benefit/risk profile for Melphalan/HDS, and that the study’s objectives can be met. There is strong interest from leading cancer centers in the U.S. and Europe to participate in this study and we look forward to beginning enrollment in this registrational trial,” CEO Jennifer Simpson said in a press release.
The company said the agreement also satisfied a “substantial number of the FDA’s issues in the Complete Response Letter issued in September, 2013,” according to a press release. The issues mentioned were related to the safety of a previous generation of the drug device combo and procedure.
The company’s new Focus trial aims to evaluate the safety and efficacy of the drug device combo versus the best alternative care, with an endpoint of overall survival and secondary endpoints including progression-free survival, overall response rate and quality of life measures.