Biotech Values

[ronpopeil]

From the 10K:

Phase III—Melanoma Metastases Trial
Our most advanced trial is a randomized Phase III multi-center study for patients with unresectable metastatic ocular or cutaneous melanoma exclusively or predominantly in the liver. The primary endpoint of the study is to determine hepatic progression free survival, which is the length of time a patient is both alive and free from any significant increase in the size of the tumor within the liver.

In the trial, patients are randomly assigned to receive treatments with melphalan using the Delcath PHP System, or to a control group providing best alternative care. Patients assigned to the Delcath PHP System may receive up to six cycles of treatment at approximately four to six week intervals. Patients randomized to the non-Delcath PHP System arm are permitted to cross-over into the Delcath arm at documentation of hepatic disease progression. To date, a majority of the control patients have been crossed over to the treatment arm. Secondary objectives of the study are to determine the response rate, safety and tolerability of treatments using the Delcath PHP System in patients with cutaneous and ocular melanoma metastatic to the liver and the patterns of recurrence of patients treated with the Delcath PHP System for metastatic melanoma, and to determine the overall survival in patients with hepatic metastases following treatment with standard treatments and after treatment with the Delcath PHP System.