PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. announced that the FDA gave it the green light to test its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19). “We’re going to be evaluating whether an injection of our cells intravenously can tone down the immune system just enough so it gets rid of the virus but doesn’t destroy your lungs at the same time,” Mesoblast CEO Silviu Itescu told BioWorld.
HONG KONG – Another promising candidate has emerged in the race to find a treatment for the COVID-19 coronavirus. San Diego-based Ansun Biopharma Inc. released positive results from a four-patient study of its DAS-181 candidate, which is being developed for the treatment of severe COVID-19 infection.
Pluristem Therapeutics Inc., an Israeli regenerative medicine company, said several of the seven COVID-19 patients treated with its allogeneic placental expanded (PLX) cells have progressed from suffering severe symptoms of the disease to signs of clinical recovery, including respiratory improvements.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Bellus, Bicycle, Boston, Can-Fite, Crinetics, Inventiva, Kalvista, Kazia, Precision, Quantum, Seneca, Vaccinex.
Shares of Millendo Therapeutics Inc. (NASDAQ:MLND) fell 70.1% to $1.45 on April 6 after a pivotal study of its experimental Prader-Willi syndrome (PWS) therapy, livoletide, failed to show a statistically significant improvement in hyperphagia, or insatiable hunger, and food-related behaviors vs. placebo.
With positive top-line data reported for Axsome Therapeutics Inc.’s oral migraine candidate, AXS-07, in its INTERCEPT trial, the company and the candidate have notched two successful phase III trials in little more than three months.
Menlo Therapeutics Inc. announced a double dose of bad news with negative results for two phase III trials testing its NK1 receptor antagonist, serlopitant, as a treatment for pruritus (itch) associated with prurigo nodularis, a skin disease characterized by hard, itchy nodules.
DUBLIN – Immunomedics Inc. is stopping the phase III Ascent trial of its antibody-drug conjugate, sacituzumab govitecan, in triple-negative breast cancer (TNBC) on the unanimous recommendation of the study’s independent data safety monitoring committee, after a scheduled look at the study data uncovered what the company called “compelling efficacy.”
LONDON – Izana Bioscience Ltd. has become the third company to supply an anti-GM-CSF antibody for compassionate use against COVID-19, announcing namilumab, currently in phase IIb testing in the treatment of rheumatoid arthritis and ankylosing spondylitis, will be used to treat 20 patients with severe respiratory symptoms.
HONG KONG – Another promising candidate has emerged in the race to find a treatment for the COVID-19 coronavirus. San Diego-based Ansun Biopharma Inc. released positive results from a four-patient study of its DAS-181 candidate, which is being developed for the treatment of severe COVID-19 infection.
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