Delcath Systems (DCTH) To Begin Phase III with Melphalan
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Delcath Systems, Inc. (NASDAQ: DCTH) announced today that sufficient events have been reached to allow data analysis to begin on its Phase III trial. The trial uses the drug melphalan to treat patients with metastatic melanoma in the liver.
"We remain very optimistic that the Phase III trial will achieve a successful endpoint," said Eamonn P. Hobbs, President and CEO of Delcath. "Assuming a successful trial endpoint, we remain committed to filing our NDA with the FDA in April," Mr. Hobbs added.
The 92 patient, randomized, multi-center, Phase III study commenced patient enrollment in February 2006. Patients were randomly assigned to receive treatments with ultra-high doses of the chemotherapeutic drug melphalan infused directly into the liver via the Delcath PHP System™ or to a control group, where they were provided with best alternative care (BAC). BAC included alternative regional or systemic therapies. Patients assigned to the Delcath arm were eligible to receive up to six cycles of treatment at approximately four to six week intervals. Patients randomized to the non-PHP arm were permitted to cross-over into the Delcath arm at documentation of hepatic disease progression.
The study's primary objective was to demonstrate a statistically significant improvement in the hepatic progression free survival (HPFS) of patients with metastatic melanoma (ocular or cutaneous) to the liver treated with the Delcath PHP System™ versus patients in the control arm. Secondary endpoints include response rate, duration of response and overall survival.
"We remain very optimistic that the Phase III trial will achieve a successful endpoint," said Eamonn P. Hobbs, President and CEO of Delcath. "Assuming a successful trial endpoint, we remain committed to filing our NDA with the FDA in April," Mr. Hobbs added.
The 92 patient, randomized, multi-center, Phase III study commenced patient enrollment in February 2006. Patients were randomly assigned to receive treatments with ultra-high doses of the chemotherapeutic drug melphalan infused directly into the liver via the Delcath PHP System™ or to a control group, where they were provided with best alternative care (BAC). BAC included alternative regional or systemic therapies. Patients assigned to the Delcath arm were eligible to receive up to six cycles of treatment at approximately four to six week intervals. Patients randomized to the non-PHP arm were permitted to cross-over into the Delcath arm at documentation of hepatic disease progression.
The study's primary objective was to demonstrate a statistically significant improvement in the hepatic progression free survival (HPFS) of patients with metastatic melanoma (ocular or cutaneous) to the liver treated with the Delcath PHP System™ versus patients in the control arm. Secondary endpoints include response rate, duration of response and overall survival.
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