Date: 2016-01-14
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Fujifilm Corporation (Japan)
Product: FF-21101
Action
mechanism: monoclonal antibody/radiopharmaceutical. FF-21101 is an anti-cancer agent using a radioisotope labeled antibody (armed antibody**), with a different mechanism of action from a regular antibody. A regular antibody drug binds to specific proteins that express on the surface of cancer cells and induces the immune function to attack targeted cells. This type of drugs is less effective on patients with a compromised immune system. FF-21101, on the other hand, accumulates radiolablled antibodies on cancer cells, and uses radiation emitted by the radioisotope to directly attack cancer cells. This is why it is expected to have a higher level of efficacy, regardless of the state of patients' immune system. FF-21101 uses antibodies that target P-cadherin***, which is over-expressed on the surface of solid cancer cells, and accumulated in lung cancer cells, pancreatic cancer cells, etc.
Disease: solid tumors
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The purpose of this study is to determine the safety and tolerability in subjects who receive FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors. ( NCT02454010)
Latest
news: * On January 14, 2016, Fujifilm Corporation announced that the company has begun a Phase I clinical trial of its anti-cancer agent FF-21101 in the United States in patients with advanced solid tumors such as lung cancers in 12 January. The trial is carried out at The University of Texas MD Anderson Cancer Center. Fujifilm has organized the technologies of Group companies to develop FF-21101. The bio-venture, Perseus Proteomics, has contributed to drug-discovery for the antibody, while the biopharmaceutical contract manufacturer, Fujifilm Diosynth Biotechnologies, has taken charge of antibody production. The radiopharmaceutical company, Fujifilm RI Pharma, offered its technology for developing the diagnostic and therapeutic radiopharmaceuticals.
