Business Wire

FUJIFILM Corporation Announces Results from Phase II Clinical Trial of "T-817MA" in Patients with Alzheimer's Disease in the United States

Del

FUJIFILM Corporation (TOKYO: 4901) (President: Kenji Sukeno) announced that the company’s Alzheimer’s Disease drug “T-817MA,” did not meet its primary study endpoints of cognition or global clinical function in its Phase II clinical trial conducted in the United States on patients with mild to moderate Alzheimer’s Disease (AD). There were no significant differences in secondary outcomes. In exploratory analyses, change of the cerebrospinal fluid (CSF) biomarker phospho-tau (p-Tau) benefited from the higher dose treatment while hippocampal*1 volumes decreased less in the lower doses group with statistical significance. Post hoc analyses also suggested T-817MA treatment with shorter duration of illness and symptoms was associated with better cognitive outcomes with statistical significance. Fujifilm will review the results of the Phase II clinical trial with regulatory authorities including FDA (U.S. Food and Drug Administration) and will take necessary steps toward further development including Phase III clinical trial of this compound.

A pre-clinical research, led by Dr. Rudolph Tanzi, Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard Medical School, and Vice-Chair of Neurology at Massachusetts General Hospital, revealed that T-817MA acts on microglia*2 that have a risk gene for AD and promotes the clearance of amyloid-β (Aβ).
These results suggest that T-817MA may act on p-Tau and Aβ, major causal substances in AD.

AD’s main symptoms are abnormalities in cognitive functions, including memory. It is believed that abnormality of neurological functions in AD manifests as a result of Aβ protein deposits (senile plaques) in the brain. The progression of the disease has strong association with the formation of abnormal assemblies caused by hyperphosphorylation and fibrillization of tau proteins, found in the axons of nerve cells (neurofibrillary tangle), synapse*3 loss and atrophy of the brain including hippocampus.
The number of people suffering from dementia is estimated to be 44 million around the world. The number is projected to increase to 76 million by 2030 with the aging of the world population. Over half of these dementia cases suffer from AD, and the trend is set to continue.
AD drugs currently available on the market include acetylcholinesterase inhibitors, such as donepezil hydrochloride. As these drugs address the deficit in neurotransmission to give temporary improvement to the patients' symptoms, there is an unmet need for a new class of therapies to treat AD.

T-817MA is an AD drug discovered by the Fujifilm Group company, Toyama Chemical. It has potent neuroprotective effect and promotes neurite outgrowth through the activation of sigma receptors*4, demonstrating strong efficacy in animal models. Fujifilm is committed to further accelerating the development of T-817MA under possible partnerships, and contributing to resolving social challenges through the delivery of innovative pharmaceutical products.

 
  *1   Hippocampus is a region of the cerebrum, associated with memory. AD causes neuronal loss, which results in hippocampal atrophy.
*2 Microglia are a type of glia cells, which are component of the central nervous system. Microglia provide immune defense in the brain, while also being involved in repairing abnormal neural cells, and eliminating the aggregated Aβ. At the same time, excessively activated microglia are known to play a role in neuro-degeneration in the central nervous system.
*3 Synapse is a structure connecting neurons, allowing them to pass electrical signals to convey information between them.
*4 Sigma receptors are protein that exists on the membrane of endoplasmic reticulum in cells, and have the function of mitigating neuro-degeneration in the central nervous system.
 

Contact information

For enquiries on information in this media release, contact:
Media contact
FUJIFILM Corporation
Kana Matsumoto, +81 3-6271-2000
Corporate Communications Division
Other
FUJIFILM Corporation
Pharmaceutical Products Division
TEL +81 3-6271-2171

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Pierre Fabre & Array BioPharma Announce a 62% Observed OS at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO GI Congress23.6.2018 11:00Pressemelding

Not intended for UK- and US-based media Pierre Fabre and its partner Array BioPharma Inc. today announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF V600E -mutant metastatic colorectal cancer (CRC). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines

Compelling Data for LONSURF® (trifluridine/tipiracil) in Metastatic Colorectal Cancer Presented at ESMO’s World Congress on Gastrointestinal Cancer by Servier and Taiho23.6.2018 08:10Pressemelding

Servier and Taiho Pharmaceutical Co., Ltd. today announced that the TASCO-1 trial demonstrated promising results for LONSURF® (trifluridine/tipiracil) in combination with bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) who are not suitable for intensive treatment, with a median progression-free survival (PFS) of 9.2 months (ranging from 7.6 to 11.5 months). A second non-comparative arm in the trial, evaluated the outcome of patients treated with the current standard of care of capecitabine in combination with bevacizumab. The median PFS of this arm was 7.8 months (ranging from 5.5 to 10.1 months). “Colorectal cancer is the third most common cancer in the world. While there has been some progress in treatment, there are still few options for patients with metastatic disease who are not suitable for intensive treatment,” said Professor Eric Van Cutsem, Head of Digestive Oncology at the University of Leuven, Belgium. “These compelling results suggest

Softomotive and Accelerate RPA Partner to Help Enterprises Achieve Faster Time to Value from RPA22.6.2018 15:13Pressemelding

Softomotive, a world–class Robotic Process Automation (RPA) technology provider offering best time to value and affordability for all sizes and types of enterprises, is pleased to announce a strategic partnership with AccelerateRPA, a high calibre professional services provider of trained and certified RPA Consultants within Robotic Process Automation. This partnership means that customers and end users of Softomotive’s software, will have additional knowledgeable and professional guidance available to help achieve significant value quickly from their investment in RPA. Companies who are looking to implement Softomotive’s RPA product suite (WinAutomation and ProcessRobot software) will now have direct access to AccelerateRPA’s highly skilled consultants and Developers. Further, AccelerateRPA has also become a licensed reseller of Softomotive’s products, offering customers a single point of contact for delivering both RPA software and services. Ashley Hudson, Director of AccelerateRPA,

Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 14:00Pressemelding

Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With

Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 13:41Pressemelding

Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel

Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 12:00Pressemelding

Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i