The best performer on the S&P/ASX 200 Index (ASX: XJO) on Monday has been the Mesoblast limited (ASX: MSB) share price by some distance.
In afternoon trade the allogeneic cellular medicines developer's shares are up a sizeable 8% to $3.65.
Why is the Mesoblast share price storming higher today?
Investors have been buying the company's shares after it provided an update on its allogeneic mesenchymal stem cell (MSC) product candidate, remestemcel-L.
According to the release, an expanded access protocol (EAP) has been initiated in the United States for compassionate use of remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C).
This means that patients aged between two months and 17 years may receive one or two doses of remestemcel-L within five days of referral under the EAP.
The company advised that the protocol was filed with the United States Food and Drug Administration (FDA) and provides physicians with access to remestemcel-L for an intermediate-size patient population under its existing Investigational New Drug application.
What is MIS-C?
MIS-C is a life-threatening complication of COVID-19 in otherwise healthy children and adolescents. It includes massive simultaneous inflammation of multiple critical organs and their vasculature.
In approximately 50% of cases this inflammation is associated with significant cardiovascular complications that directly involve the heart muscle and may result in decreased cardiac function.
Furthermore, the virus can result in dilation of coronary arteries with unknown future consequences.
Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes 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 therapy comprises culture-expanded mesenchymal stem cells that are derived from the bone marrow of an unrelated donor. It is then administered in a series of intravenous infusions.
Important therapeutic benefits.
Mesoblast's Chief Medical Officer, Dr Fred Grossman, appears optimistic that remestemcel-L can offer important therapeutic benefits to MIS-C patients.
He commented: "The extensive body of safety and efficacy data generated to date using remestemcel-L in children with graft versus host disease suggest that our cellular therapy could provide a clinically important therapeutic benefit in MIS-C patients, especially if the heart is involved as a target organ for inflammation."
"Use of remestemcel-L in children with COVID-19 builds on and extends the potential application of this cell therapy in COVID-19 cytokine storm beyond the most severe adults with acute respiratory distress syndrome," he concluded.
