FUJIFILM Corporation (President: Shigehiro Nakajima) is to conduct clinical development of three anticancer agents (FF-10501, FF-10502 and FF-21101) with The University of Texas MD Anderson Cancer Center (hereinafter “MD Anderson Cancer Center”)*, one of the world's most distinguished facilities for cancer research and treatment, in its move to develop anticancer drugs in the United States. To beginning with, Phase I clinical trial for FF-10501 is set to start next spring, at the testing for other agents to follow.
Tapping into the advanced ability to synthesize and design chemical compounds and analysis technologies, nurtured through the development of photographic film, Fujifilm has defined “oncology” as its focal area, and has actively been conducting R&D for anticancer agents. Anticancer agents currently in the pipeline include FF-10501 (Indication: Hematological cancer), developed through uncovering new mechanisms of action and identifying biomarker candidates for verifying efficacy, FF-10502 (Indication: Pancreatic cancer, etc.), which is expected to offer excellent efficacy and enhanced production adaptability due to its highly efficient synthetic process, and FF-21101 (Indication: Lung cancer, etc.), which conjugates antibodies with radioisotope for enhanced efficacy. In May this year, the company initiated Phase I clinical trial of FF-10501 in patients with relapsed or refractory myelodysplastic syndromes (MDS)** in Japan.
MD Anderson Cancer Center, which will carry out the clinical trial, is one of the world's top general cancer centers with over 10,000 patients on therapeutic clinical trials each year and some 20,000 employees. Fujifilm is to utilize the world's largest pool of clinical trial participants at MD Anderson Cancer Center to perform speedy and seamless clinical tests in Phase I and Phase II to gain a Proof of Concept*** at an early stage.
The clinical trial at MD Anderson Cancer Center will be organized in cooperation with Boston Strategics Corporation (hereinafter “BSC”). Cooperation with BSC, which boasts a global network of experts in pre-clinical and clinical development, Fujifilm will adopt a next-generation global clinical development model, flexibly forming a taskforce for each project rather than establishing a large-scale in-house R&D unit for clinical testing, for efficient R&D.
Fujifilm is working on the R&D of innovative pharmaceutical products and creation of their production processes by combining the technologies and know-how accumulated in the photographic film business including chemical synthesis capacity, design ability, analysis technology, nanotechnology and production technology, with the technological expertise of its core pharmaceutical affiliates such as Toyama Chemical and FUJIFILM RI Pharma. Defining “oncology”, a field with numerous unmet medical needs, as its focal area, the company will actively promote R&D to expand business deployment and supply innovative pharmaceutical products so as to contribute to the development of medical care around the world.
* One of the world's largest cancer centers based in Houston, Texas, specializing in cancer treatment, research, education and prevention. It was established in 1941 with a mission to eliminate cancer. Under the core values of “Caring”, “Integrity” and “Discovery”, the center has developed numerous new cancer treatments as an international leader in oncology.
** A type of hematological malignancies, in which the disorder of blood-forming “hematopoietic stem cells” causes inefficient production of blood cells, triggering cytopenia. It is also a refractory disease for some patients with poor prognosis, progressing to acute myeloid leukemia. Currently, over 10,000 people in Japan and over 60,000 people in the United States are estimated to suffer from MDS.
*** Acknowledge (not confirmation) of efficacy of a new drug through (human) clinical trial
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