FUJIFILM Corporation has decided to partner with the University of California San Diego based Alzheimer’s disease Cooperative Study (“ADCS”), in order to carry out a Phase II clinical trial of the Alzheimer’s Disease drug “T-817MA” to accelerate its development in the United States.
The ADCS is the largest Alzheimer’s Disease therapeutic research consortium in the United States, led by Dr. Paul Aisen, one of the leading investigators in the field of Alzheimer’s Disease in the US, and the clinical trial is scheduled to start in January 2014 with Fujifilm carrying it out through the activities of Toyama Chemical.
Drugs for treating Alzheimer’s disease, currently available on the market, include acetylcholinesterase inhibitors. They improve disease’s symptoms by boosting neurotransmission, but do not readily suppress the progression of the disease itself. In the course of research at the affiliate Toyama Chemical for pharmaceutical means of suppressing the progression of Alzheimer’s Disease, Fujifilm identified “T-817MA”, which offers a powerful protection for neurons, promotes neurite outgrowth*1 and demonstrates the effects strongly in animal models.
In a Phase II trial already carried out in the United States, T-817MA showed a tendency to inhibit deterioration in efficacy assessments including cognitive assessment scores and a clinical global impression of change rating*2 in patients with mild to moderate Alzheimer’s Disease, as well as demonstrating a positive safety profile. It showed clearer efficacy in patients whose symptoms have progressed to a moderate stage.
ADCS is a therapeutic research consortium established in the United States with funding from the National Institute on Aging, a branch of the National Institutes of Health, for the development of drugs and assessment tools for Alzheimer’s disease. ADCS works in collaboration with scores of participating sites and has extensive experience in clinical trials in the field of Alzheimer’s disease.
The latest move by Fujifilm to initiate a joint clinical trial with ADCS developed after ADCS reviewed and agreed to investigate T-817MA’s potential to become an innovative treatment option for Alzheimer’s disease. No U.S. federal funding will be used in the project.
Making use of the results of the previous clinical trial, Fujifilm will recruit a group of patients on whom T-817MA can demonstrate its potential, to be tested in the Phase II trial so as to examine its efficacy and dose response. With the collaboration with ADCS, the company will advance the quality and pace of the clinical investigation to accelerate the development of T-817MA.
The number of dementia patients is estimated to be 36 million worldwide, and is predicted to reach some 66 million by 2030. Of those, there are over 5 million Alzheimer’s disease patients in the United States, and the figure is said to reach 8 million by 2030.
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 so as to contribute to the development of medical care around the world.
*1 Neuron has multiple neurites projecting out from its cell body like tree branches to receive external stimuli or information transmit from other neurons. T-817MA offers a “neurite outgrowth effect”, promoting the outgrowth of neurites.
*2 Assessment method in which a doctor compares the results of interviews with a patient and his/her career, conducted before and after the administration of a drug, to identify changes in the patient.
4 December 2013