Mesoblast is committed to a program of clinical development of universal MPC products which target orthopaedic conditions including bone fractures, degenerative diseases of joint cartilage, and damaged intervertebral discs.
Overview
The process incorporates:
• completion of pre-clinical regulatory development
and scale-up of its MPC products to good manufacturing
practice (GMP) standards to meet US FDA requirements;
• completion of proof-of-principle clinical
trials in one or more orthopaedic indications;
• completion of all pre-clinical and clinical
requirements for submission of an investigational
new drug (IND) application for the use of MPCs in
an orthopaedic field; and
• assisting Angioblast, through Mesoblast's
equity investment, to undertake proof-of-principle
clinical trials and submit IND applications in one
or more cardiovascular indications.
The pre-clinical dossiers that will be presented by Mesoblast and Angioblast Systems to the US FDA as part of the IND applications will consist of a GMP manufacturing and scale-up component, and the results of trials demonstrating safety and efficacy of MPC administration to animals with orthopaedic and cardiovascular conditions.
Mesoblast anticipates that the results of the proof-of-principle clinical trials using an individual's own MPC will be available at the same time as those of the pre-clinical studies. The inclusion of these data in the dossiers submitted to the FDA is expected to enhance significantly the likelihood of approval of IND applications to initiate multi-centre clinical trials using donated MPC in orthopaedic and cardiovascular indications.
Due to the shared nature of the platform technology, the cost of the pre-clinical development program up to the stage of submitting the IND application will be shared between Mesoblast and Angioblast according to commercially agreed terms. After completion of the pre-IND phase, each company will be responsible for completing its own multi-centre studies.
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