An announcement was made today by the interventional oncology company, the Delcath Systems, Inc., about finishing the enrollment of patients for its FOCUS trial that aims to confirm the prospect of its investigational combination treatment of MOM, metastatic ocular melanoma with hepatic dominance, suffering patients. According to the announcement, 90 patients in total were enrolled for the trial. The company focuses on how to treat liver cancers of primary and metastatic levels.
The outcome of the FOCUS trial is expected to be announced by Delcath by the middle of this year.
Delcath aims to keep the enrollment open for the patients who suffer from unresectable hepatic-dominant MOM since there is a lack of successful treatments for the disease. The enrollment will continue until the practicability of an Expanded Access Program (EAP) is determined by Delcath.
High-dose chemotherapy is administered in the liver effects by designing Melphalan/HDS injection uniquely, with minimum exposure and least side effects as the chemotherapy agent are filtered out from the blood.
The CEO and President of Delcath, Jennifer Simpson, said that it gives them pleasure that a minimum target for the enrollment of patients for the FOCUS trial has been reached. She commented that the results are expected to be announced by the end of the first half of this year. Jennifer is a Ph.D. holder. She ensured the commitment of Delcath towards the advancement of its clinical development program and promised to bring this vital therapy to the mOM patients in the market of the USA by working together with the FDA.
Dr. Simpsons believes that Melphalan/HDS can be proved to be an effective treatment for mOM, which needs utmost medical care.
The FOCUS trial is single-arm, an open-label study which will be run over at the United States and Europe with a total of 80 patients suffering from mOM, the metastatic ocular melanoma, as the subject.