"We hope that this particular product will make bone marrow transplantation a more widely used and safer option for critically ill patients who undergo chemotherapy to potentially cure blood cancer.
"This product has the potential to be the first of our revenue generating biologic therapies in both the United States and Europe," Professor Itescu added.
The Phase 3 trial will be conducted together with Mesoblast's strategic alliance partner, Cephalon Inc., who will fund the trial.
About Orphan Drug DesignationOrphan drug designation is reserved for therapies which are being developed for conditions affecting up to 200,000 patients annually in the United States, and allows for an accelerated review process by the FDA, seven-year market exclusivity in the United States upon obtaining marketing authorization, tax benefits, and exemption from user fees. Mesoblast Limited Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY) is a world leader in the development, manufacture, and commercialization of biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights to a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). More information - www.mesoblast.com For further information, please contact: Julie Meldrum Corporate Communications Director T: + 61 (0) 3 9639 6036 E: julie.meldrum@mesoblast SOURCE Mesoblast Limited