Delcath expands global Phase 2 program to treat hepatocellular carcinoma

NewsGuard 100/100 Score

Delcath Systems, Inc. (NASDAQ: DCTH) announces the expansion of its global Phase 2 program for the treatment of patients with unresectable hepatocellular carcinoma (HCC) or primary liver cancer. Montefiore Medical Center in the Bronx, New York has joined the U.S. Phase 2 HCC study and is now open for patient enrollment. The Company now has two centers participating in the U.S. Phase 2 HCC study, with another three centers in Germany enrolling patients in the EU Phase 2 HCC study. The Company expects to include up to seven centers in Europe and the United States in its global Phase 2 HCC program, and will seek to enroll approximately 30 patients in total.

HCC is the most common primary cancer of the liver, with approximately 700,000 new cases diagnosed worldwide annually. Surgical removal is not possible for an estimated 80-90 percent of primary liver cancer patients. In the U.S., the Phase 2 study will investigate the safety and efficacy of Melphalan/HDS treatment followed by sorafenib in patients with unresectable liver cancer confined to the liver, evaluate tumor response (objective response rate), as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), assess progression-free survival, safety, and the safety of sorafenib following treatment with Melphalan/HDS. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan/HDS, as well as an assessment of patient-reported clinical outcomes, or quality-of-life.

"We are pleased to have Montefiore Medical Center, a nationally recognized Center of Excellence for cancer care and clinical research, as a part of our global Phase 2 HCC program," said Jennifer Simpson, Ph.D., Delcath's Interim President and CEO. "We now have five centers open for patient enrollment in the program, and with our prospective commercial registry in Europe also now open for enrollment, we are continuing to execute on all elements of our Clinical Development Program."

SOURCE Delcath Systems, Inc.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
New PET imaging agent shows promise in visualizing lesions in clear cell renal cell cancer patients