FUJIFILM Corporation (President: Shigehiro Nakajima) has begun a Phase I clinical trial of its anti-cancer agent FF-10501 in the United States in patients with relapsed or refractory myelodysplastic syndromes (MDS). The trial is carried out at The University of Texas MD Anderson Cancer Center*, one of the world's most distinguished facilities for cancer research and treatment.
MDS is a type of hematological malignancy, 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, MDS patients in the United States are estimated to be around 60,000, many of them in the senior age group.
FF-10501 is Fujifilm's first internally-developed drug candidate to undergo clinical trial, with a Phase I trial already underway in Japan. Tapping into the advanced ability to synthesize and design chemical compounds nurtured through the development of photographic films, the company has developed FF-10501 through enhancing the drug's temporal stability and applying strong analysis technology to elucidate new mechanisms of action and identify biomarker candidates for verifying its efficacy. The agent is expected not only to inhibit the growth of hematological cancer cells but also promote their differentiation to cells with normal functions.
MD Anderson Cancer Center 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 top-level clinical testing functions available at the MD Anderson Cancer Center to carry out Phase I and early Phase II clinical trials to gain safety and preliminary proof of activity at an early stage. This time, Dr. Guillermo Garcia-Manero M.D., a world-renowned expert in MDS, leads the clinical trial as the principal investigator.
Fujifilm is also partnering with Dr. Garcia-Manero in joint research on FF-10501, using cancer cells derived from MDS patients. Findings from the joint research will be applied to the clinical program in an effort to further accelerate the development of FF-10501.
Fujifilm is working on the R&D of innovative pharmaceutical products and creation of the 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 resolving challenges social issues.