Delcath Systems said Wednesday that its liver-tumor treatment device achieved the primary goal of a late-stage clinical trial, but questions about the strength of the data — and whether the results will satisfy regulators — caused the small company’s stock price to fall.
The Delcath device, called Hepzato, consists of clamps, tubes, and a filter that isolate a patient’s liver from the rest of the bloodstream. Once the liver is blocked off, it is bathed in high doses of the chemotherapy melphalan to kill tumors. The Hepzato filter removes the melphalan from the patient before it can escape the liver, enter the bloodstream, and cause severe side effects or death.
The company has been on a years-long quest to secure Hepzato’s approval to treat patients with advanced ocular melanoma, a rare form of skin cancer in the eye that often spreads to the liver. In 2013, the Food and Drug Administration rejected a previous iteration of the device because the filter allowed too much toxic melphalan to escape into the bloodstream, causing side effects that outweighed any potential benefit.
Melphalan is not the first drug that comes to mind when an oncologist talks about treatment hepatocellular carcinoma or a melanoma. But there is a reason, if I am not too far off, for choosing this drug. Melphalan and Cyclophosphamide are alkylating agents, there malignant cells can develop only so much resistances (where as for some drug, huge levels of resistance can be made). Furthermore, the toxic side effects are limited to bone marrow suppression (unless mammoth doses are given). One has to ask the question “why Melphalan?” Are there not more effective drugs against HCC and Melanoma?
Comments are closed.