HLB "Regorafenib, Patient Enrollment for Shenyang Cystic Carcinoma Clinical Trial"

[Asia Economy Reporter Hyunseok Yoo] HL Biopharma announced on the 10th that its subsidiary Elevar has registered the first patient in a Phase 2 clinical trial at the University of California for the treatment of Adenoid Cystic Carcinoma (ACC) with Rivoceranib.

This study is a clinical trial evaluating the efficacy and safety of Rivoceranib for all recurrent or metastatic Adenoid Cystic Carcinoma. Last year, an open-label, multi-center Phase 2 IND clinical trial involving 55 patients was approved by the US FDA and the Korean Ministry of Food and Drug Safety. The clinical trial is being conducted at seven institutions in the US, including the University of California, Dana-Farber Cancer Institute, and the University of Michigan, and in Korea at Seoul National University Hospital, Asan Medical Center, Samsung Medical Center, and the National Cancer Center.

Professor Hyunseok Kang of the University of California, participating in this clinical trial, stated, “Adenoid Cystic Carcinoma is a very difficult disease with no standard treatment options beyond repeated surgery or radiation. I am pleased to administer Rivoceranib to the first patient,” and emphasized the clinical significance by adding, “According to clinical results from China, Rivoceranib is expected to be a useful treatment option for patients with Adenoid Cystic Carcinoma.”

The primary endpoint of this study is the Objective Response Rate (ORR), and the secondary endpoints include Overall Survival (OS), Progression-Free Survival (PFS), Disease Control Rate (DCR), and safety evaluations.

Dr. Steven Norton, Chief Development Officer of Elevar, said, “This clinical trial represents a great opportunity for patients with Adenoid Cystic Carcinoma, for whom there are no appropriate treatments,” and added, “We expect Rivoceranib to bring a change in the treatment paradigm for Adenoid Cystic Carcinoma.”

Adenoid Cystic Carcinoma is a rare cancer with approximately 1,200 cases annually in the United States. Elevar announced plans to apply for orphan drug designation with the US FDA.

Meanwhile, Rivoceranib (Chinese name Apatinib), which is marketed in China as a treatment for gastric cancer, has recently completed the application for marketing approval as a second-line treatment for liver cancer, signaling a positive outlook for expanded indications. With the initiation of patient enrollment in the Phase 2 trial for Adenoid Cystic Carcinoma, the value of Rivoceranib is expected to further increase.

Jinwoo Jang, Director of HL Biopharma, stated, “Following HL Biopharma’s acquisition of global rights, including China, from Advancen, the developer of Rivoceranib, on the 27th of last month, the increase in sales due to expanded indications by Hansoh Pharmaceutical and Elevar will directly translate into royalty income for HL Biopharma, which is expected to generate stable and long-term operating profits.”

This content was produced with the assistance of AI translation services.