The New York-based company presented the results from its study at the Cardiology and Interventional Radiology of Europe annual meeting in Copenhagen, Denmark.
The investigational product, an injectable melphalan hydrochloride for use with Delcath’s hepatic delivery system, is designed to administer high-dose chemotherapy to the liver while limiting systemic exposure and side effects.
The study assessed filtration efficiency and hematologic side effects in seven patients who received PHP procedures with Delcath’s Gen2 Chemosat system.
Data from the study showed that the Gen2 Chemosat boasts an overall efficiency of 86%, with efficiency highest at the time of peak concentration of melphalan in the blood and declining in line with melphalan blood concentration. The company said that these results are better than those published with the 1st-gen Chemosat system.
The researchers also noted that there was no mortality, no severe bleeding complications and no hypotensive cardiac or cerebral events.
“This study provides good external confirmation of the filtration efficiency capability and consistent performance seen with the Gen2 Chemosat, and is consistent with what we are seeing in the commercial setting,” Delcath president & CEO Jennifer Simpson said in prepared remarks. “This study also indicates that the hematologic side effects of treatment with Chemosat are manageable. We look forward to validating these observations in our registration trials, which include robust evaluation of the pharmacokinetic characteristics of the PHP procedure.”