Top member reports
Company Report
Last edited 4 years ago
PerformanceCommunity EngagementCommunity Endorsement
Performance (60m)
3.1% pa
Followed by
248
Straws
Sort by:
Recent
Content is delayed by one month. Upgrade your membership to unlock all content. Click for membership options.
#ASX Announcements
stale
Added 4 years ago

MESOBLAST PARTNERS WITH THE CARDIOTHORACIC SURGICAL TRIALS NETWORK ESTABLISHEDBY THE U.S. NATIONAL INSTITUTES OF HEALTH’S NATIONAL HEART, LUNGAND BLOOD INSTITUTE TO CONDUCT RANDOMIZED CONTROLLED TRIAL OF REMESTEMCEL-L FOR PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME DUE TO COVID-19

Melbourne, Australia; Thursday April 9, 2020; and New York, USA;

Wednesday April 8, 2020:

Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials. Mesoblast holds an Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS, and will provide investigational product for the trial.

...

ARDS occurs due to an excessive immune response against the COVID-19 virus in the lungs, with the inflammatory cytokines produced by the immune cells (cytokine storm) destroying the lung tissue. These inflammatory cytokines also can cause damage to other organs such as liver, kidney, and heart.

Remestemcel-L is being developed for various inflammatory conditions, and is believed to counteract the inflammatory processes implicated in these diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues. The safety and therapeutic effects of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in various clinical trials.

Remestemcel-L was successful in a Phase 3 trial for steroid-refractory acute graft versus host disease (aGVHD) in children, a potentially fatal inflammatory condition due to a similar cytokine storm process as is seen in COVID-19 ARDS. Additionally, a post-hoc analysis of a randomized, placebo-controlled study in 60 patients with chronic obstructive pulmonary disease demonstrated that remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also observed in patients with COVID-19 ARDS. Together, these outcomes provide the rationale for evaluating remestemcel-L in patients with COVID-19 ARDS.

...