Regenerative Medicine Company
Melbourne, April 28, 2009 AEST (ABN Newswire) - Australian regenerative medicine company, Mesoblast Limited (ASX:MSB(PINK:MBLTY), today announced it has received approval at Melbourne's Epworth hospital to commence a Phase 2 trial of its allogeneic, or "off-the-shelf", cell therapy product for fusion of the cervical spine.
The 24-patient randomised, controlled trial will compare the safety and effectiveness of Mesoblast's product NeoFuse(TM) against a procedure using a patient's own hipbone (autograft). In recently completed preclinical trials at Australia's Monash University, Mesoblast's allogeneic cells resulted in earlier and more robust fusion of the cervical spine than autograft, without any adverse events.
As many as 200,000 spinal fusion procedures of the cervical spine are performed annually in the United States alone for irreversible, end-stage degenerative disc disease. The limited options currently available to patients in need of cervical fusion make this a major commercial opportunity for Mesoblast and one that may represent an accelerated path to market entry.
The excellent safety profile seen in preclinical studies with Mesoblast's product NeoFuse(TM) was particularly important in view of the recent notification to surgeons by the United States Food and Drug Administration (US FDA) concerning life threatening complications associated with use of an alternative therapy for cervical fusion, recombinant human Bone Morphogenetic Protein (rhBMP).
Mesoblast Executive Director, Professor Silviu Itescu, said that cervical fusion represented a major, new market opportunity within a broader strategy of building a franchise for treatment of spinal diseases. These include spinal fusion of the lumbar (the lower back) and cervical (neck) vertebrae for end-stage degenerative intervertebral disc disease, and repair/regeneration of the discs for patients with earlier stage disease.
Contact
Julie Meldrum
Corporate Communications Director
Mesoblast Limited
T: + 61 (03) 9639 6036
M: +61 (0) 419 228 128
E: julie.meldrum@mesoblast.com
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