Coronavirus second wave: Countries across Europe are seeing a resurgence in COVID-19 cases after successfully slowing outbreaks early in the year. The vast majority of countries are declaring more cases
With United States trials for its prospective COVID-19 treatment now at the Stage 3 stage, regenerative health and wellness company Mesoblast (ASX: MSB, NASDAQ: MESO) has today obtained an advancement for evaluating the stem cell-based intravenous option in Australia.
The Melbourne-based team has today introduced it received ethics approval to include Australian healthcare facilities in the Phase 3 randomised regulated test of remestemcel-L in ventilator-dependent COVID-19 clients with intense respiratory system distress syndrome (ARDS).
Taking part medical facilities in Melbourne as well as Sydney have actually been approved approval by the Human being Study Ethics Committee of Monash Health and wellness, and will join greater than 17 leading US clinical facilities already in the Phase 3 test.
This study is being carried out by the US National Institutes of Health-funded Cardiothoracic Surgical Trial Run Network, as well as gotten rid of by the US Fda (FDA).
"As an Australian firm creating a potential treatment for COVID-19 ARDS, the primary cause of death in individuals infected with COVID-19, we have a responsibility to examine remestemcel-L in Australian people as the country continues to come to grips with COVID-19," says Mesoblast president and founder Dr Silviu Itescu (pictured).
"We are pleased that Monash Health is associated with this important COVID-19 test, specifically provided the extensive experience we have had with Mesoblast's mesenchymal lineage cells," includes principal investigator, Associate Professor Tony Goldschlager.
The firm's shares have actually increased considering that April when restemcel-L produced encouraging cause a small cohort of severely unwell COVID-19 clients in New york city, with 83 percent enduring compared to a 12 percent rate at the time for those in comparable situations.
Prior to COVID-19 and also the firm's pivot to treat the virus, Mesoblast was worth $1.56 billion. Today it is worth more than $3 billion.
Mesoblast is using its proprietary technology platform to develop and commercialize innovative allogeneic cellular medicines to treat complex diseases resistant to conventional standard of care and where inflammation plays a central role.
The Company’s portfolio of Phase 3 product candidates comprises RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD), remestemcel-L for the treatment of moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection, REVASCOR® for advanced chronic heart failure and MPC-06-ID for chronic low back pain due to degenerative disc disease.
The United States Food and Drug Administration (FDA) has accepted for priority review Mesoblast’s Biologics License Application (BLA) to seek approval of RYONCIL for acute GVHD in children. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020. If approved, Mesoblast will make RYONCIL immediately available in the United States.
The Company also has a promising emerging pipeline of product candidates and next generation technologies.
Innovative technology platform enables scalable manufacturing
Mesoblast’s novel allogeneic product candidates are based on rare (approximately 1:100,000 in bone marrow) mesenchymal lineage cells that respond to tissue damage, secreting mediators that promote tissue repair and modulate immune responses.
Mesenchymal lineage cells are collected from the bone marrow of healthy adult donors and proprietary processes are utilized to expand them to a uniform, well characterized, and highly reproducible cell population. This enables manufacturing at industrial scale for commercial purposes. Another key feature of Mesoblast’s cells is they can be administered to patients without the need for donor–recipient matching or recipient immune suppression.
Proprietary media formulations, advances in development of 3D bioreactor technology and automation are intended to deliver step-changes improvement in product yield.
Robust Intellectual Property Estate
Mesoblast has an extensive patent portfolio comprising approximately 1,000 patents and patent applications with protection extending through 2040 in all major markets. This intellectual property portfolio covers composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells. The Company believes this patent estate provides strong global protection in areas of its core commercial focus.
Evidence-based Science and Translational Medicine
Mesoblast’s mesoblast share price approach to product development is to ensure rigorous scientific investigations are performed with well-characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical translational studies guide clinical trials that are structured to meet stringent safety and efficacy criteria set by international regulatory agencies. All trials are conducted under the continuing review of independent Data Safety Monitoring Boards comprised of independent medical experts and statisticians. These safeguards are intended to ensure the integrity and reproducibility of results, and to ensure that outcomes observed are scientifically reliable. mesoblast share price fall.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). mesoblast share price asx
MESOBLAST LIMITED - Charts / Financials
Board - msb asx
|Dr. Silviu Itescu||Chief Executive Officer, Executive Director|
|Mr. William M. Burns||Non-Executive Independent Vice Chairman of the Board|
|Mr. Joshua B. Muntner||Chief Financial Officer|
|Ms. Dagmar Rosa-Bjorkeson||Chief Operating Officer|
|Mr. Eric Strati||Senior Vice President - Commercial|
|Mr. Peter Howard||General Counsel, Corporate Executive|
|Dr. Fred Grossman||Chief Medical Officer|
|Dr. John McMannis||Head of Manufacturing|
|Dr. Paul Simmons||Head of Research and New Product Development|
|Ms. Geraldine Storton||Head of Regulatory Affairs and Quality Management|
|Mr. Joseph R. Swedish||Non-Executive Independent Chairman of the Board|
|Mr. Donal Paul O'Dwyer||Non-Executive Independent Director|
|Dr. Eric A. Rose||Non-Executive Independent Director|
|Mr. Michael R. Spooner||Non-Executive Independent Director|
|Ms. Shawn Cline Tomasello||Non-Executive Independent Director|