Delcath Systems (NSDQ:DCTH) said it added 2 German research centers to a global Phase II trial of its Chemosat melphalan hepatic delivery system in treating primary liver cancer.
The 2 facilities, Hannover Medical School Hospital and Jena University Hospital, are open for enrollment in the study. They join Goethe University Hospital in Frankfurt and Moffitt Cancer Center in Tampa, Fla., according to a press release.
The Phase II program is expected to include up to 7 research centers and approximately 30 patients, New York-based Delcath said.
The Chemosat system is designed to isolate the liver from the rest of the circulatory system and then saturate it with the chemotherapy drug melphalan chloride. The system is designed to then remove the drug from the patient’s blood before restoring the connection between the liver and the bloodstream.
Delcath has had a rough ride in the U.S. since May 2013, when a FDA advisory panel declined to recommend approval, citing safety concerns. The FDA later said Delcath would need to conduct additional testing to proceed with the application.
Chemosat is approved in Europe as a delivery system for the drug, but in the U.S. regulators have classified it as a combination drug/device product.
Delcath’s shares have trended steadily downward since the FDA events, sliding from a 2-year high of $31.36 in March 2013 to a 2-year low of $1.09 earlier this month. A 16-to-1 reverse stock split, conducted in April 2014, also pushed down share prices.
In September, Delcath named Jennifer Simpson as interim CEO as part of a broader managerial restructuring.
Delcath shares closed up 5.9% yesterday at $1.43 apiece.
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