MESOBLAST RECEIVES FDA CLEARANCE FOR PHASE 2 STEM CELL CLINICAL TRIAL
Australia’s adult stem cell company, Mesoblast Limited (ASX:MSB), today announced that the United States Food and Drug Administration (US FDA) has cleared its Investigational New Drug Submission (IND) to commence a Phase 2 clinical trial for spinal fusion in the US.
Mesoblast Founder and Chief Scientific Adviser, Professor Silviu Itescu, said: “This is a major milestone for Mesoblast as clearance of our IND submission by the FDA validates the company’s preclinical and clinical strategies for developing well characterised, safe, and effective adult stem cell products. “FDA clearance is a significant step towards commercialising our stem cell products in the major US market,” Professor Itescu added.
Mesoblast’s commercial strategy is to generate a series of high margin stem cell products that are obtained from a single donor, commercially expanded and frozen, and subsequently used in hundreds to thousands of unrelated, or allogeneic, recipients at the time and place of need.
Mesoblast is developing allogeneic (unrelated recipient) stem cell products for treatment of various medical conditions, including long bone fractures and degenerative intervertebral disc disease, both rapidly growing, billion dollar markets. In preclinical studies, Mesoblast’s stem cells have generated statistically superior long bone repair and spinal fusion compared with controls.
Professor Itescu said this Phase 2 trial would be the first ever to test allogeneic, or ‘off-the- shelf’, adult stem cells for the treatment of spinal disc disease. “The results of the trial will be used to support a pivotal Phase 3 clinical trial of Mesoblast’s patented technology for spinal fusion, aiming to eliminate the need for autograft (or patient’s own hip bone graft), reduce complications associated with existing treatment regimens, and improve fusion outcomes”, he said.
During the conduct of the Phase 2 spinal fusion trial, Mesoblast will continue to work closely with several major international medical device companies, with a view to establishing strategic alliances for product sales and distribution at the most appropriate time.
About Mesoblast
Mesoblast Limited (ACN 109 431 870) is an Australian biotechnology company committed to commercialisation of novel treatments for orthopaedic conditions, including a unique adult stem cell technology aimed at the regeneration and repair of bone and cartilage. Mesoblast has worldwide exclusive rights to a series of patents and technologies that have been developed over more than 10 years relating to the identification, extraction and culture of adult Mesenchymal Precursor Cells (MPCs). The company has a substantial equity holding in Angioblast Systems Inc, an American company developing the platform MPC technology for the treatment of cardiovascular diseases, including repair and regeneration of blood vessels and heart muscle. Mesoblast's strategy is to maximise shareholder value through both corporate artnerships and rapid product commercialisation.
