Alzheimer's Disease Cooperative Study

Vivoryon Therapeutics N.V. Reports Positive Outcome from Independent Data Safety Monitoring Board with Unanimous Decision for VIVA-MIND U.S. Study of Varoglutamstat in Alzheimer’s Disease to Proceed at Highest Investigated Dose

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Monday, October 23, 2023
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VIVA-MIND (NCT03919162) is an ongoing Phase 2 study for varoglutamstat conducted in the U.S., complementary to Vivoryon’s VIVIAD Phase 2b study being conducted in Europe.

Key Points: 
  • VIVA-MIND (NCT03919162) is an ongoing Phase 2 study for varoglutamstat conducted in the U.S., complementary to Vivoryon’s VIVIAD Phase 2b study being conducted in Europe.
  • The primary endpoint of the study is evaluating Clinical Dementia Rating scale Sum of Boxes (CDR-SB) over a 72-week treatment period.
  • “We are thrilled to report this new important and validating element of our rigorously and meticulously designed program for varoglutamstat.
  • Vivoryon remains on track to report the final data readout from the VIVIAD study in the first quarter of 2024.

Eisai: Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM

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Friday, January 28, 2022
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Biogen aims to enroll 18 percent of U.S. participants in ENVISION from Black/African American and Latinx populations.

Key Points: 
  • Biogen aims to enroll 18 percent of U.S. participants in ENVISION from Black/African American and Latinx populations.
  • Based on enrollment rates from the previous Phase 3 trials with ADUHELM, the primary completion date is expected to be approximately four years after the study begins.
  • This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM.
  • The patient's healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA.

DGAP-News: Vivoryon Therapeutics N.V.: Vivoryon Therapeutics N.V. Reports Q3 2021 Financial Results and Highlights Operational Progress

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Thursday, November 4, 2021
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"Throughout the third quarter, we made significant progress towards filling the gap of safe, widely available effective disease-modifying therapies in Alzheimer's disease.

Key Points: 
  • "Throughout the third quarter, we made significant progress towards filling the gap of safe, widely available effective disease-modifying therapies in Alzheimer's disease.
  • VIVIAD remains on track for an interim safety readout in mid-22 and Vivoryon continues to anticipate final data in the second half of 2023.
  • Research and development expenses incurred for the nine months ended September 30, 2021 increased over the corresponding period in 2020 by EUR 3.6 million.
  • General and administrative expenses increased by EUR 1.2 million for the nine months ended September 30, 2021.

SHAREHOLDER ALERT: Robbins LLP Investigates Annovis Bio, Inc. (ANVS) for Misleading Shareholders

Retrieved on: 
Wednesday, November 3, 2021
Legal, Professional Services, Alzheimer's disease, Patient, NYSE, Company, Neurodegeneration, News, Alzheimer's Disease Cooperative Study, Gian Maria Annovi, Securities Exchange Act of 1934, Parkinson's disease, Pharmaceutical industry

Shareholder rights law firm Robbins LLP is investigating Annovis Bio, Inc. (NYSE: ANVS) to determine whether certain Annovis officers and directors violated the Securities Exchange Act of 1934.

Key Points: 
  • Shareholder rights law firm Robbins LLP is investigating Annovis Bio, Inc. (NYSE: ANVS) to determine whether certain Annovis officers and directors violated the Securities Exchange Act of 1934.
  • Its lead compound is ANVS401 (Posiphen), which purportedly inhibited the synthesis of neurotoxic proteins that are the main cause of neurodegeneration.
  • If you would like more information about Annovis Bio, Inc.'s misconduct, click here .
  • On May 21, 2021, Annovis touted the positive results of its ANV401 clinical trials, noting improvements in the ANVS401-treated group compared to placebo group.

DGAP-News: Vivoryon Therapeutics N.V.: Vivoryon Therapeutics Provides Update on Business and Progress of Varoglutamstat Clinical Development in Alzheimer's Disease

Retrieved on: 
Monday, October 18, 2021
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Patients will then be treated for a minimum of 48 weeks on the selected dose twice daily vs. placebo.

Key Points: 
  • Patients will then be treated for a minimum of 48 weeks on the selected dose twice daily vs. placebo.
  • A composite Neuropsychological Test Battery (NTB) score will be administered throughout the study in order to assess cognitive efficacy.
  • Secondary endpoints include long-term safety and tolerability of varoglutamstat and its efficacy on brain activity, cognition and activities of daily living.
  • "We are following a diligently designed development strategy and making continued progress towards overcoming the challenges of drug development in AD, moving varoglutamstat through clinical development as efficiently as possible," said Dr. Ulrich Dauer, CEO of Vivoryon.

DGAP-News: Vivoryon Therapeutics N.V.: Vivoryon Therapeutics N.V. Reports H1 2021 Financial Results and Operational Progress

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Tuesday, September 21, 2021
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"In the first half of 2021, we made significant progress towards bringing our lead candidate varoglutamstat to patients suffering from Alzheimer's disease.

Key Points: 
  • "In the first half of 2021, we made significant progress towards bringing our lead candidate varoglutamstat to patients suffering from Alzheimer's disease.
  • In the first two quarters of 2021, research and development expenses amounted to EUR 9,456 k (H1 2020: EUR 6,380 k).
  • This increase was mainly driven by higher expenses for production (H1 2021: EUR 4,194 k, H1 2020: EUR 1,876 k), expenses for share-based payments (H1 2021: EUR 464 k, H1 2020: EUR 3 k) and higher costs associated with basic research projects in connection with Meprin (H1 2021: EUR 220 k, H1 2020: nil) and cancer (H1 2021: EUR 162 k, H1 2020: nil).
  • This increase is largely attributable to costs for consulting (H1 2021: EUR 1,030 k, H1 2020: EUR 481 k) and expenses for share based payments (2021: EUR 464 k, 2020: nil).

SHAREHOLDER ALERT: Robbins LLP Announces that Annovis Bio, Inc. (ANVS) is Being Sued for Misleading Shareholders

Retrieved on: 
Wednesday, September 15, 2021
Legal, Professional Services, Patient, Alzheimer's disease, Securities Exchange Act of 1934, Alzheimer's Disease Cooperative Study, Company, Parkinson's disease, NYSE, Neurodegeneration, Person, Complaint, News, Pharmaceutical industry

Its lead compound is ANVS401 (Posiphen), which purportedly inhibited the synthesis of neurotoxic proteins that are the main cause of neurodegeneration.

Key Points: 
  • Its lead compound is ANVS401 (Posiphen), which purportedly inhibited the synthesis of neurotoxic proteins that are the main cause of neurodegeneration.
  • If you suffered a loss due to Annovis Bio, Inc.'s misconduct, click here .
  • According to the complaint, during the relevant period, Annovis conducted two Phase 2a clinical studies.
  • On May 21, 2021, Annovis touted the positive results of its ANV401 clinical trials, noting improvements in the ANVS401-treated group compared to placebo group.

GemVax & KAEL reports further positive data from GV1001 Phase II Alzheimer's Disease trial

Retrieved on: 
Monday, November 23, 2020
Health sciences, Cognitive disorders, Learning disabilities, Psychiatric diagnosis, Health, Branches of biology, Treatment of Alzheimer's disease, Nootropics, Alzheimer's disease, Donepezil, Dementia, Alzheimer's Disease Cooperative Study

SEOUL, Nov. 23, 2020 /PRNewswire/ -- GemVax & KAEL Co., Ltd. a clinical stage company developing a novel peptide drug based on telomerase modification has released further positive data at the Korean Dementia Association's Fall Conference from a Phase II trial in Alzheimer's disease of lead candidate GV1001.

Key Points: 
  • SEOUL, Nov. 23, 2020 /PRNewswire/ -- GemVax & KAEL Co., Ltd. a clinical stage company developing a novel peptide drug based on telomerase modification has released further positive data at the Korean Dementia Association's Fall Conference from a Phase II trial in Alzheimer's disease of lead candidate GV1001.
  • The newly released data also shows a statistically significant improvement in theNeuropsychiatric Inventory (NPI) and an improvement trend in Alzheimer's Disease Cooperative Study-Activities of Daily living (ADCS-ADL).
  • GemVax's GV1001 Phase II clinical trial evaluated the safety and efficacy of subcutaneous injection of GV1001 0.56 mg or 1.12 mg for six months in patients with moderate-to-severe Alzheimer's disease already receiving donepezil for more than three months, at 12 medical institutions.
  • Professor Koh, agrees, "If efficacy and safety results of GV1001 in the phase III clinical trial are the same as or superior to the Phase II clinical trial, it will be able to establish itself as a game-changer in Alzheimer's disease treatment".

GemVax & KAEL reports further positive data from GV1001 Phase II Alzheimer's Disease trial

Retrieved on: 
Monday, November 23, 2020
Health sciences, Cognitive disorders, Learning disabilities, Psychiatric diagnosis, Health, Branches of biology, Treatment of Alzheimer's disease, Nootropics, Alzheimer's disease, Donepezil, Dementia, Alzheimer's Disease Cooperative Study

SEOUL, Nov. 23, 2020 /PRNewswire/ -- GemVax & KAEL Co., Ltd. a clinical stage company developing a novel peptide drug based on telomerase modification has released further positive data at the Korean Dementia Association's Fall Conference from a Phase II trial in Alzheimer's disease of lead candidate GV1001.

Key Points: 
  • SEOUL, Nov. 23, 2020 /PRNewswire/ -- GemVax & KAEL Co., Ltd. a clinical stage company developing a novel peptide drug based on telomerase modification has released further positive data at the Korean Dementia Association's Fall Conference from a Phase II trial in Alzheimer's disease of lead candidate GV1001.
  • The newly released data also shows a statistically significant improvement in theNeuropsychiatric Inventory (NPI) and an improvement trend in Alzheimer's Disease Cooperative Study-Activities of Daily living (ADCS-ADL).
  • GemVax's GV1001 Phase II clinical trial evaluated the safety and efficacy of subcutaneous injection of GV1001 0.56 mg or 1.12 mg for six months in patients with moderate-to-severe Alzheimer's disease already receiving donepezil for more than three months, at 12 medical institutions.
  • Professor Koh, agrees, "If efficacy and safety results of GV1001 in the phase III clinical trial are the same as or superior to the Phase II clinical trial, it will be able to establish itself as a game-changer in Alzheimer's disease treatment".