Spectrum Pharmaceuticals announced on March 8 that the company has initiated the U.S. Phase 2, open-label clinical trial for Poziotinib, its novel pan-HER inhibitor.
The study will enroll approximately 70 patients with HER2-positive metastatic breast cancer who have failed existing therapies, and Poziotinib dosage and cycle will be based on Hanmi’s Phase 1 and 2 studies in Korea.
Poziotinib is a novel, oral pan-HER inhibitor, which is jointly being developed by Hanmi Pharmaceuticals and Anticancer Drug Development Agency, which is led by Director Kim In-cheol and supported by the Korean government's National Cancer Center, under the Ministry of Health and Welfare. Hanmi is also carrying out the Phase 2 clinical trial for Poziotinib in patients with non-small cell lung cancer and breast cancer in Korea.
Spectrum Pharmaceuticals has entered into a licensing agreement with Hanmi Pharmaceuticals for Poziotinib in Feb. last year. Under the terms of the agreement, the company received exclusive licensing rights to develop, manufacture and commercialize worldwide excluding Korea and China.
“We believe Poziotinib has the potential to be the best in class pan-HER inhibitor,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “We will provide a new treatment option for cancer patients who have developed resistance to existing drugs.”
As a NASDAQ-listed company, Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. The company currently markets five new anti-cancer drug products, including FUSILEV for the treatment of patients with osteosarcoma and ZEVALIN injection for patients with follicular non-Hodgkin's lymphoma, in the U.S.