The Human Research Ethics Committee of Monash Health Grants an Approval to Mesoblast Limited (NASDAQ:MESO) to Treat COVID-19 Patients in Australia

Throughout its many years of operation, Mesoblast Limited (NASDAQ:MESO) has established a culture of creating clinically differentiated products. The use of a proprietary technology platform has enabled the manufacturing scale-up of a broad portfolio of commercial products and late-stage product candidates. Nonetheless, its primary focus is on allogeneic cellular medicines for inflammatory diseases.

The company’s portfolio comprises of RYONCIL™ (remestemcel-L), REVASCOR®, and MPC-06-ID. Remestemcel-L is a treatment for moderate to severe acute respiratory distress syndrome (ARDS) caused by COVID-19 infection. The investigational therapy is the lead candidate for Mesoblast and is undergoing a Phase 3 randomized controlled trial. It is being developed as a potential treatment for ventilator-dependent COVID-19 patients with acute respiratory distress syndrome (ARDS).

Approval to Treat COVID-19 Patients in Australia

There are already more than 17 leading US medical centers participating in the Phase 3 trial. Some hospitals in Melbourne and Sydney will also join following an ethics approval by the Human Research Ethics Committee of Monash Health. The FDA has cleared the study and will be carried out by the US National Institutes of Health-funded Cardiothoracic Surgical Trials Network.

“As an Australian company developing a potential treatment for COVID-19 ARDS… we have a responsibility to evaluate remestemcel-L in Australian patients as the country continues to grapple with COVID-19,” Mesoblast CEO, Dr. Silviu Itescu announced.

Mesoblast Has a Strong Presence and Global Intellectual Property (IP) In Major Markets

Tony Goldschlager, the Principal Investigator A/Prof is saying they are enthusiastic about the involvement of Monash Health in the COVID-19 trial. He also acknowledges the broad familiarity they have a hand with Mesoblast’s mesenchymal lineage cells.

Having taken control of its proprietary mesenchymal lineage cell therapy technology platform Mesoblast has established a heavy presence in all major markets. This is all due to a protected global intellectual property (IP) portfolio.

Meanwhile, the company has gained approval for its Biologics License Application of its RYONCIL™ (remestemcel-L). This is supposedly for pediatric steroid-refractory acute graft versus host disease. The FDA approved the BLA, and the candidate’s launch is likely to take place before the end of the year before it can become available in the US market.