Fujifilm Starts a U.S. Phase I Clinical Trial of Anti-Cancer Agent FF-10832 on Advanced Solid Tumors
Clinical Development of Liposome Drug for Improvement of Pharmacological Efficacy through Selective Delivery of Anti-Cancer Agent to Tumors
May 9, 2018
FUJIFILM Corporation (President: Kenji Sukeno) announced the start of a U.S. Phase I clinical trial of the anti-cancer agent FF-10832 for advanced solid tumors. FF-10832 is a liposome-based agent in which the existing water-soluble anti-cancer agent gemcitabine*1 is encapsulated in liposomes by harnessing Fujifilm’s advanced nano-dispersion technology, analysis technology, and process technology cultivated through the photographic film business.
Liposomes are artificially constructed vesicles made from the same organic phospholipids that make up cell and bio membranes. They provide a type of drug delivery system (DDS) technology that delivers the required amount of a drug to the specific area of the body on a predetermined schedule. In some cases, anti-cancer agents can act on healthy tissues instead of the tumor, leading to adverse side effects, however, by encapsulating a drug in a liposome, it is expected that the drug will be enabled to be selectively delivered to the tumor, suppressing side effects, and enhancing the pharmacological efficacy of the drug.
Gemcitabine has a short elimination half-life*2 in the blood. When FF-10832, a liposome that has a uniform size of approximately 80nm, encapsulates gemcitabine, it is expected to enable the following: increase the stability of the agent within the blood, demonstrate an EPR effect*3, where the agent accumulates within the tumor and is retained for an extended period of time, and enable the release of the agent within the tumor. Experiments on mice demonstrated that when administered as a liposome drug with a low dose amounting to 1/60th of a dose, the pharmacological benefit of FF-10832 significantly exceeded the outcomes compared to an existing preparation not formulated with a liposome. The pharmacological benefit of FF-10832 was also confirmed in mice where certain types of cancer cells (derived from humans) were transplanted, in which gemcitabine does not demonstrate particular effectiveness. Going forward, Fujifilm will be studying the safety, tolerability, pharmacokinetics, and initial efficacy of FF-10832 on advanced solid tumors in Phase I clinical trials in the U.S.
Fujifilm is harnessing its advanced nano-dispersion technology, analysis technology, and process technology cultivated through the photographic film business to promote the research and development of liposome drugs. Currently, the company is also undertaking initiatives with the aim of applying the technologies not only to existing drugs but expanding to next-generation drugs such as nucleic acid drugs and gene therapy drugs. Working towards meeting the global supply of liposome drugs, the company made the decision to build a facility that will manufacture liposome drugs for the study phase and commercial phase in the pharmaceutical production site of the Fujifilm group company, Toyama Chemical Co., Ltd. Preparations are underway to the start operations in February 2020.
Fujifilm is undertaking the development of new drugs in key areas such as oncology as well as developing new drug delivery systems by utilizing its proprietary technologies and aims to contribute to the resolution of social issues through the creation of new value.
*1 An anti-cancer drug (generic name: gemcitabine, product name: Gemzar) developed by the U.S. company Eli Lilly and Company. It is used as a drug of first choice for the treatment of pancreatic cancer, and is also indicated for the treatment of a wide range of other cancers (such as lung cancer and ovarian cancer).
*2 The time required for the concentration of a drug in the blood to be reduced to half.
*3 Tumors generate blood vessels for their own nutrition, but these newly generated blood vessels are not fully developed, and have gaps that are not present in normal blood vessels. When liposomes and polymers are retained within the blood, they do not permeate the walls of normal blood vessels, which have no gaps, permeating only the vascular walls around the tumor. In addition, as the lymph tissues are not fully developed in tumors, the liposomes and polymers that have permeated are not easily eliminated, resulting in the accumulation of these liposomes and polymers in the tumor. This is called the EPR (enhanced permeability and retention) effect. Published by Hiroshi Maeda, Professor at Sojo University, DDS Research center and Professor Emeritus, Kumamoto University, and Yasuhiro Matsumura, Director at Division of Development Therapeutics at the National Cancer Center’s Exploratory Oncology Research & Clinical Trials Center (NCC-EPOC) in “A new concept for macromolecular therapeutics in cancer chemotherapy: mechanism of tumoritropic accumulation of proteins and antitumor agent smancs.” (1986). Both Dr. Maeda and Dr. Matsumura were recognized as “Thomson Reuters Citation Laureates” in 2016, announced by Thomson Reuters as potential Nobel Prize candidates for publications, citations, and analysis.
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