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Quercis Announces Special Protocol Assessment Agreement with U.S. Food and Drug Administration

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ZUG, Switzerland, May 4, 2021 /PRNewswire/ Quercis Pharma AG, a private, clinical stage biopharmaceutical company leveraging its novel antithrombotic platform, today announces that it has entered into a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the protocol titled,
A Randomized, Placebo-Controlled, Double-Blind Phase 3 Trial Comparing, Relative to Placebo, the Effect of Isoquercetin on Thromboembolic Events in Patients with Metastatic Pancreatic Cancer (CATIQ P3).
Isoquercetin, the Company s lead product candidate, employs a novel pathway that is based on a new mechanism of action to prevent or reverse thrombus formation with a profile that potentially conveys substantially lowered bleeding risk compared to current standard of care. These mechanisms are related to key thrombotic pathways, including the inhibition of soluble P-selectin, which is known to help prevent ....

Jeffrey Zwicker , Manon Veraart , Quercis Pharma , Stefan Wohlfeil , Beth Israel Deaconess Medical Center , Drug Administration , Professor Of Medicine At Harvard Medical School , Special Protocol Assessment , Double Blind Phase , Thromboembolic Events , Metastatic Pancreatic Cancer , Associate Professor , Harvard Medical School , Benign Hematology , Beth Israel Deaconess Medical , Chief Medical Officer , Special Protocol Assessments , Quercis Pharma Ag , பெத் இஸ்ரேல் டேப்ககோணேஸ் மருத்துவ மையம் , ப்ரொஃபெஸர் ஆஃப் மருந்து இல் ஹார்வர்ட் மருத்துவ பள்ளி , சிறப்பு ப்ரோடொகால் மதிப்பீடு , இரட்டை குருட்டு கட்டம் , மெட்டாஸ்டேடிக் கணையம் புற்றுநோய் , இணை ப்ரொஃபெஸர் , ஹார்வர்ட் மருத்துவ பள்ளி , பெத் இஸ்ரேல் டேப்ககோணேஸ் மருத்துவ ,

BioArctic : Lecanemab (BAN2401) Phase 2b study in early Alzheimer's disease published in peer-reviewed journal, Alzheimer's Research & Therapy

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Stockholm April 20, 2021 - BioArctic AB s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer s Disease with Lecanemab, an Anti-Aβ Protofibril Antibody, in the peer-reviewed journal Alzheimer s Research & Therapy. The manuscript describes results from Study 201, a Phase 2b proof-of-concept study that explored the impact of treatment with lecanemab on reducing brain amyloid beta (Aβ) and clinical decline in patients with early Alzheimer s disease. The manuscript concluded that the analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the pivotal Phase 3 study Clarity AD aims to confirm. ....

Oskar Bosson , Gunilla Osswald , Alzheimer Research Therapy , Stockholm April , Nasdaq Stockholm , Double Blind Phase , Concept Clinical Trial , Early Alzheimer , Protofibril Antibody , Vice President Communications , Investor Relations , Bioarctic Ab Publ Stock Exchange , Press Release , N Bioab Se0010323311 , முதுமறதி ஆராய்ச்சி சிகிச்சை , ஸ்டாக்‌ஹோல்ம் ஏப்ரல் , நாஸ்டாக் ஸ்டாக்‌ஹோல்ம் , இரட்டை குருட்டு கட்டம் , கருத்து மருத்துவ சோதனை , ஆரம்ப முதுமறதி , துணை ப்ரெஸிடெஂட் தகவல்தொடர்புகள் , முதலீட்டாளர் உறவுகள் ,

Lecanemab (BAN2401) Phase 2b study in early Alzheimer's disease published in peer-reviewed journal, Alzheimer's Research & Therapy

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STOCKHOLM, April 20, 2021 /PRNewswire/ BioArctic AB s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer s Disease with Lecanemab, an Anti-Aβ Protofibril Antibody, in the peer-reviewed journal Alzheimer s Research & Therapy. The manuscript describes results from Study 201, a Phase 2b proof-of-concept study that explored the impact of treatment with lecanemab on reducing brain amyloid beta (Aβ) and clinical decline in patients with early Alzheimer s disease. The manuscript concluded that the analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the pivotal Phase 3 study Clarity AD aims to confirm. ....

Oskar Bosson , Gunilla Osswald , Alzheimer Research Therapy , Nasdaq Stockholm , Double Blind Phase , Concept Clinical Trial , Early Alzheimer , Protofibril Antibody , Vice President Communications , Investor Relations , முதுமறதி ஆராய்ச்சி சிகிச்சை , நாஸ்டாக் ஸ்டாக்‌ஹோல்ம் , இரட்டை குருட்டு கட்டம் , கருத்து மருத்துவ சோதனை , ஆரம்ப முதுமறதி , துணை ப்ரெஸிடெஂட் தகவல்தொடர்புகள் , முதலீட்டாளர் உறவுகள் ,

18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimers Disease Published in Peer-Reviewed Journal, Alzheimers Research and Therapy

18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimers Disease Published in Peer-Reviewed Journal, Alzheimers Research and Therapy
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United Kingdom , United States , Haruo Naito , Walter Gilbert , Charles Weissmann , Heinz Schaller , Michel Vounatsos , David Caouette , Jeffrey Cummings , Mike Hencke , Michael Irizarry , Kenneth Murray , Department Of Brain Health , Alzheimer Association International Conference , Investor Relations Department , National Institute On , Biogen Inc , University Of Nevada Las Vegas , Grundy Center , Public Relations Department , Alzheimer Research , National Institutes Of Health , Eisai Inc , Eisai Co Ltd , Exchange Commission , Neurology Business Group ,

Eisai: 18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimer's Disease

Eisai: 18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimer's Disease
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Jeffrey Cummings , Michael Irizarry , Department Of Brain Health , Alzheimer Research , Alzheimer Association International Conference , Eisai Inc , Biogen Inc , University Of Nevada Las Vegas , Eisai Co Ltd , School Of Integrated Health Sciences , Neurology Business Group , Grundy Center , Peer Reviewed Journal , Double Blind Phase , Concept Clinical Trial , Early Alzheimer , Anti Abeta Protofibril Antibody , Association International Conference , Clinical Trials , Chambers Grundy Center , Transformative Neuroscience , Brain Health , Integrated Health Sciences , Nevada Las , Vice President , Deputy Chief Clinical Officer ,