Progress in a phase I clinical trial in the United States for the anti-cancer agent "FF-10501" Positive results in relapsed or refractory patients with blood cancer


FUJIFILM Corporation (President: Shigehiro Nakajima) is announcing the progress in a Phase I clinical trial of anti-cancer agent FF-10501 in the United States in patients with relapsed or refractory myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The emerging results have revealed that to date FF-10501 was well tolerated in those patients and produced partial remission* and marrow complete remission** in some patients.

These results were presented on December 7th at the 57th American Society of Hematology Meeting (Orland, Florida), the biggest hematology meeting in the world, by principal investigator, Professor Garcia-Manero MD, of The University of Texas MD Anderson Cancer Center*** (MD Anderson Cancer Center hereafter).

MDS is a type of hematological malignancy, in which the disorder of blood-forming hematopoietic stem cells (myelodysplasia) causes inefficient production of blood cells triggering cytopenia. Current MDS patients in the United States and in Japan are estimated to be around 60,000 and 11,000, respectively, many of them in the senior age group. It is also a refractory disease progressing to AML for some patients with poor prognosis.

AML is characterized by a higher rate of abnormal hematopoietic stem cells in bone marrow than in MDS, and inefficient production of blood cells and peripheral organ failure due to migrating myeloblasts. The numbers of patients with AML in the United States and in Japan are estimated to be around 25,000 and 6,000, respectively.

Fujifilm initiated the Phase I clinical trial of FF-10501 in patients with blood cancer at MD Anderson Cancer Center in the United States in August 2014. Although the trial is still underway, some positive responses have been observed in the study as follows:

— FF-10501 was well tolerated in all 17 patients [AML (13), MDS (4)]
— FF-10501 produced stable disease in 6 AML and 2 MDS patients
— FF-10501 produced 2 partial remissions in AML patients and 1 marrow complete remission in MDS patients
Fujifilm will continue the study to further evaluate tolerability and efficacies with higher doses at MD Anderson Cancer Center and proceed to early Phase IIa study.

Fujifilm tapped into the advanced technology to synthesize and design chemical compounds, nurtured through the development of photographic films, to develop FF-10501. The technology utilized in the development for enhancing its 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.

Fujifilm is dedicated to research and development for innovative pharmaceutical products and new 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 pharmaceutical affiliates such as Toyama Chemical. Defining “oncology”, a field with numerous unmet medical needs, as its focal area, the company will actively promote research and development to expand business deployment and supply innovative pharmaceutical products so as to contribute to resolving social issues.

  • *All complete remission criteria with ≥50% decrease in abnormal hematopoietic stem cells (bone marrow blasts or leukemia cells) over pre-treatment (but still > 5%).
  • **In bone marrow, ≤ 5% abnormal hematopoietic stem cells (myeloblasts) and decrease by ≥ 50% over pre-treatment.
  • ***One of the world's largest cancer centers based in Houston, Texas (USA), 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.

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