In its presentation to the advisory panel the company said the remestemcel manufacturing process has been improved since those trials in ways that have made the treatment more potent.The panel voted on whether MesoBlast provided enough clinical data to show that its therapy was effective in treating aGVHD in this narrower group. Its decision on remestemcel is anticipated by September’s end. An FDA advisory committee Thursday voted 9-1 to recommend that the agency approve a stem cell therapy developed by MesoBlast as a treatment for acute graft-versus-host disease (aGVHD) in children. Xconomy is a registered service mark of Xconomy, Inc. Hedge funds and other institutional investors own 2.11% of the company's stock. Treatment with systemic corticosteroids can help control the severity of the condition.
)“I do think that the two prior randomized trials convincingly show that the [earlier version of remestemcel], at least in the population that was being studied, which is similar but not the same, clearly did not have meaningful activity,” Hinrichs said. But the company said randomization and controlled design would be incorporated into a planned post-marketing study in adults.In previous clinical trials in wider patient populations, the treatment missed the primary goal. Mesoblast in April announced an … Mesoblast has a highly experienced management team made up of individuals who have held senior positions in international pharmaceutical and biotechnology companies.
This enables manufacturing at industrial scale for commercial purposes. This team is responsible for the strategic direction, operations and success of our company. Mesoblast is committed to bringing to market innovative cellular medicines to treat serious and life-threatening diseases with significant, unmet medical needs.Mesoblast is using its proprietary mesenchymal lineage cell technology platform to develop and commercialize innovative allogeneic cellular medicines to treat complex inflammatory diseases resistant to conventional standard of care.The Company’s portfolio of Phase 3 product candidates are:Mesoblast’s Biologics License Application (BLA) for RYONCIL for the treatment of children with steroid-refractory acute GVHD has been accepted for priority review by the United States Food and Drug Administration (FDA).
But in up to 90 percent of aGVHD patients who don’t respond to steroid treatment, the condition can prove fatal.MesoBlast’s submission was based on a clinical trial that enrolled 55 children age 2 months to 17 years who had received a transplant of bone marrow, peripheral blood stem cells, or cord blood, were diagnosed with aGVDH and weren’t responding to steroid therapy. In March and April, Mesoblast conducted a small study at New York City's Mount Sinai Hospital to evaluate if its lead drug candidate, remestemcel-L, could … The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.The Company also has a promising emerging pipeline and next generation technologies.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.
Bank of New York Mellon Corp now owns 12,788 shares of the company's stock worth $145,000 after purchasing an additional 1,000 shares in the last quarter. The panel weighed the need for a new way to address the potentially fatal condition against shortcomings of the clinical trial the Australian biotech conducted to evaluate the investigational cell therapy.The MesoBlast cell therapy, remestemcel-L (Ryoncil), is made from mesenchymal cells taken from healthy donors. All rights reserved. “So, you know, do we think that these tweaks to the manufacturing have suddenly made it highly effective, and the change in patient population has suddenly made it highly effective?”Jorge Garcia, division chief of solid tumor oncology at University Hospitals Seidman Cancer Center in Cleveland, however, said while it isn’t clear how the treatment compares to other drugs used to treat patients with the condition, the data indicate it is safe and has shown “some efficacy.”Although the FDA considers advisory panel recommendations during drug reviews, committee recommendations are not binding, and the agency doesn’t always follow them. You can reach her at sdecrescenzo@xconomy.com.
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