Delcath begins 90-patient Phase 2 cancer trial

• Delcath Systems dosed the first patient in a Phase 2 trial evaluating its HEPZATO treatment.
• The company stated it will enroll roughly 90 patients across more than 20 global clinical sites.
• Management expects the trial will address an estimated 7,000 US patients lacking primary therapeutic alternatives.

Delcath Systems (NASDAQ:DCTH) dosed the first patient in a 90-person Phase 2 clinical trial evaluating a cancer therapy.

The study compares the safety and efficacy of the HEPZATO treatment alongside standard care against standard care alone.

"Dosing the first patient in this Phase 2 trial at the IEO in Milan, Italy is an important milestone," said Delcath Systems Chief Executive Officer Gerard Michel.

Management stated the trial focuses on liver-dominant HER2-negative metastatic breast cancer patients who failed prior treatments.

The company anticipates further clinical evaluations.

The primary endpoint for this clinical study is determining the hepatic progression-free survival rate of enrolled subjects.

The business stated this specific target condition affects approximately 7,000 potential third-line treatment candidates annually within the United States.