IDWeek 2024: Moderna’s norovirus vaccine mRNA-1403 shows …
Oct 21, 2024 · At IDWeek 2024, Moderna presented interim results from an ongoing Phase I/II, randomised, observer-blind, placebo-controlled, dose-ranging trial (NCT05992935) for mRNA-1403, a prophylactic vaccine candidate under investigation for norovirus (NoV) infections. As one of the leading causes of acute gastroenteritis worldwide, NoV is associated with a substantial healthcare burden.
Outlook Therapeutics stock craters as wet AMD drug fails Phase III …
Nov 27, 2024 · Outlook Therapeutics’ second attempt to obtain US approval for its wet age-related macular degeneration (wet AMD) therapy, Lytenava (bevacizumab-vikg) has suffered a setback as the therapy failed to meet a key endpoint in Phase III NORSE EIGHT trial.. Although the NORSE EIGHT study (NCT06190093) did not meet the pre-specified non-inferiority endpoint at eight weeks outlined in the special ...
ESMO 2024: Moderna’s mRNA solid tumour vaccine shows early …
Sep 13, 2024 · Moderna’s mRNA cancer vaccine for solid tumours shows early signs of promise in interim data from a Phase I study.. The messenger ribonucleic acid (mRNA) specialist announced the vaccine has shown early signs of an immune response against cancer, with the shot triggering cancer-killing cells.
AHA 2024: Zerlasiran shows promising Phase II results for elevated ...
Nov 19, 2024 · Dr. Steven Nissen, MD chairman and chief academic officer of the Heart and Vascular Institute at the Cleveland Clinic and professor of medicine at the Lerner College of Medicine, reported that subcutaneous injections of 300mg or 450mg of zerlasiran, administered every 16 or 24 weeks, reduced time-averaged Lp(a) levels by 80% to 85% over a follow-up period of 36 to 60 weeks.
Cassava Sciences: Phase III trials storm ahead amid controversy
Oct 9, 2024 · In a related order, the SEC also charged Cassava consultant, Dr. Hoau-Yan Wang, an associate medical professor at the City University of New York’s (CUNY) Medical School and the therapeutic’s co-developer, for manipulating the reported clinical trial results.
Pfizer reports data from prostate cancer combination therapy trial
Oct 11, 2024 · Participants were divided into two cohorts: an all-comers group and those with homologous recombination repair (HRR) gene mutations. Radiographic progression-free survival (rPFS) was the trial’s primary endpoint while secondary endpoints comprised OS, objective response rate (ORR), duration of response (DOR) and prostate-specific antigen (PSA) response.
GSK reports positive findings from Phase III RSV vaccine trial
Oct 9, 2024 · Following the initial season, 12,469 individuals from the vaccine group were re-randomised to receive either the RSV vaccine or a placebo. The study then measured the vaccine’s efficacy over the subsequent two RSV seasons, with the results indicating a cumulative efficacy of 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD.
BlueRock reports positive data from Parkinson’s cell therapy trial
Sep 30, 2024 · The primary endpoint of safety and tolerability was assessed at 12 months, alongside evaluations of cell survival and motor effects. The results have shown that bemdaneprocel’s safety profile at 24 months was in line with prior data, indicating good tolerance and no adverse events directly related to the therapy.
HIV: Three trials to watch in 2024 - Clinical Trials Arena
Dec 18, 2023 · The year 2023 started with disappointing news for the field of human immunodeficiency virus (HIV) research after Janssen’s Phase III vaccine trial failed.. This setback has had a major impact on the industry and emphasised the need for better treatment and prevention against the virus while researchers continue to push for a vaccine.
FDA lifts clinical hold on Avidity’s lead antibody conjugate therapy …
Oct 4, 2024 · The US Food and Drug Administration (FDA) has lifted the partial clinical hold on Avidity Biosciences’ investigational drug, delpacibart etedesiran (del-desiran).. In 2022, the US regulatory agency placed a partial hold after a report of a serious adverse event in a newly enrolled patient in the Phase I/II MARINA trial (NCT05027269), which evaluated del-desiran in patients myotonic dystrophy ...