FUJIFILM Corporation Announces Results from Phase II Clinical Trial of "T-817MA" in Patients with Alzheimer's Disease in the United States
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.|
For enquiries on information in this media release, contact:
Kana Matsumoto, +81 3-6271-2000
Corporate Communications Division
Pharmaceutical Products Division
TEL +81 3-6271-2171
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Nearly 1 Billion People Worldwide Have Sleep Apnea, International Sleep Experts Estimate21.5.2018 21:15 | Tiedote
A new data analysis presented by ResMed (NYSE: RMD, ASX: RMD) this week at the ATS 2018 International Conference indicates that the prevalence of sleep apnea impacts more than 936 million people worldwide – nearly 10 times greater than previous estimates. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005096/en/ Woman wearing CPAP, the gold standard treatment for sleep apnea (Photo: Business Wire) The study “Global Prevalence of Obstructive Sleep Apnea (OSA)” was conducted by an international panel of leading researchers seeking to provide a clear scope of the impact of the chronic sleep-disordered breathing condition. The previous estimation of OSA prevalence (100 million) came from a 2007 World Health Organization study that used methods and data available at the time. By analyzing technology improvements in detecting OSA and underreported statistics from other areas of the world, this latest study depicts an impacte
Pietro Rosa TBM Signs Long-Term Agreement with Pratt & Whitney21.5.2018 18:13 | Tiedote
Pietro Rosa TBM (Turbine Blade Manufacturing) today announced that it has signed a 10-year, long-term agreement (LTA) with Pratt & Whitney, a division of United Technologies Corp., to supply airfoil products for both commercial and military engines. The LTA, which may extend to the entire Pietro Rosa TBM Group in Europe and the United States, will support Pratt & Whitney’s F135, PW2000 and the Geared Turbofan™ (GTF) family of engines. This agreement represents a significant step in the collaboration between the two companies, enabling the Pietro Rosa TBM Group to utilize its advanced engineering capabilities and the vertical integration of hot forming, machining and surface finishing technologies. “We’re pleased to sign this agreement with Pietro Rosa,” said Art Erikson, executive director of Strategic Sourcing, Pratt & Whitney. “We have tremendous growth ahead, and suppliers like Pietro Rosa that sign up to our contractual governance, commitment to cost competitiveness and continuous
NioCorp Awards Contract to Rockwell Automation on Groundbreaking Critical Minerals, Mining and Processing Facility in Nebraska21.5.2018 15:00 | Tiedote
NioCorp Developments Ltd. (TSX: NB, OTCQX: NIOBF), a developer of superalloy metals, has awarded a major contract to Rockwell Automation (NYSE: ROK) to engineer, design and procure process automation and instrumentation for NioCorp’s proposed critical minerals, mining and processing facility in Elk Creek, Nebraska. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005228/en/ Three superalloy metals – niobium, scandium and titanium – are expected to be produced by the facility as early as 2021. These critical materials are used in the aerospace, defense, automotive, clean energy, commercial aviation and mega-infrastructure sectors. Generally, these superalloys enable increased strength and lighter weight in transportation and other systems, leading to better fuel efficiency and lower greenhouse gas and other air emissions, according to NioCorp. “We selected Rockwell Automation and its partners to automate our process equip
Ultra-Low Power Lattice sensAI Leads Mass Market Enablement of Artificial Intelligence in Edge Devices21.5.2018 15:00 | Tiedote
Lattice Semiconductor Corporation (NASDAQ: LSCC) today unveiled Lattice sensAI™ – a complete technology stack combining modular hardware kits, neural network IP cores, software tools, reference designs and custom design services – to accelerate integration of machine learning inferencing into broad market IoT applications. With solutions optimized for ultra-low power consumption (under 1 mW–1 W), small package size (5.5 mm2 –100 mm2), interface flexibility (MIPI® CSI-2, LVDS, GigE, etc.), and high-volume pricing (~$1-$10 USD), Lattice sensAI stack fast-tracks implementation of edge computing close to the source of data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005011/en/ (Graphic: Business Wire) “Lattice sensAI addresses the unmet need for flexible, low cost, ultra-low power AI silicon solutions suited for rapid deployment across a wide range of emerging, mass market IoT applications,” said Deepak Boppana, senior
Biosimilars could facilitate early access to life changing biological treatments for patients says Celltrion Healthcare21.5.2018 14:27 | Tiedote
At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Celltrion Healthcare today advocated for healthcare systems to introduce biologics earlier in a patient’s treatment regimen in order to improve clinical outcomes. Several studies show that the early introduction of biologics can bring greater clinical benefit to patients.1,2,3,4,5,6 However, only a limited number of patients have access to biological treatment due to the high-cost of biologics and current reimbursement policies determined by pharmacoeconomic evaluations. Since the introduction of biosimilars, the overall cost of biological treatments has reduced in Europe, allowing an increased number of patients to access this important treatment option earlier in their course of treatment.7 Professor Jørgen Jahnsen said, “For the treatment of inflammatory bowel disease, biological treatments are proven to be the most efficacious medical therapy and their ea
Dole’s Joint Venture Recycling Company Celebrates 25 Years21.5.2018 14:00 | Tiedote
Dole Food Company announced today that Recyplast S.A., an innovative plastic recycling company based in Costa Rica and with joint ownership including a subsidiary of Dole Fresh Fruit, recently surpassed 25 years in its mission to dramatically reduce and reuse agricultural waste. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005160/en/ Raul Martinez (right), General Manager of Dole Standard Fruit de Costa Rica, receives a plaque from Jose Miguel Ramirez, General Manager of Recyplast, in recognition of the contribution of Dole's banana plantations in the correct handling, storage, and provision of field plastic waste. The plastic recycling facility pioneered the collection of field plastics after use in banana growing operations in Costa Rica. This reuse and recycling process includes reclamation of plastic bags that protect bananas from weather and insects, as well as the collection of plastic twine used to prop the ba
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme