Mesoblast to use NHMRC grant for pilot studies

By Graeme O'Neill
Tuesday, 15 March, 2005

Melbourne stem cell therapy developer Mesoblast (ASX:MSB) announced today that founder and chief scientific adviser Prof Silviu Itescu has signed a memorandum of understanding to activate a AUD$1.5 million NHMRC research grant awarded to him last year.

Mesoblast is developing therapeutic applications for adult stem cells - specifically, mesenchymal stem cells, which can be transplanted into patients without inducing rejection reactions.

Itescu and colleagues Professor Henry Crum, of Monash University, and Professor Richard Gilbert of the University of Melbourne, were joined recipients last year of a $4.5 million NHMRC program grant.

He said he would use his $1.5 million share to conduct pilot studies into the use of mesenchymal adult stem cells in applications where no adequate or alternative therapies currently exist.

These would include orthopaedic applications such as regrowing bone and cartilage to repair bone fractures and spinal-cord injuries, and regrowing coronary arteries and repairing ventricular failures caused by heart-muscle damage after heart attack.

Itescu said the pilot studies would use patients' own cells, rather than donor mesenchymal stem cells. The research was aimed at validating the company's cell-manufacturing capabilities, and confirming that the cells were safe to use in such therapeutic applications.

Mesoblast's IP - developed both in-house, and licensed in - covers techniques for identifying and isolating very pure populations of mesenchymal stem cells, and expanding them in cell culture. Mesoblast has contracted Cell Therapies, the Peter McCallum Cancer Institute's commercial arm, to scale up and manufacture significant quantities of adult stem cells for the studies.

"People are assuming that stem cell therapies are years away, but we're going to be in clinical trials this year," he said. "We expect to have investigational new drug (IND) approval from the US Food and Drug Administration within two years, that will allow us to run multi-centre clinical trials.

"We hope to have approval to market our therapies by the end of the decade. We're going about as fast as one can go with any pharmaceutical product - this is the reality of stem cell therapy today.

"There's a big difference between adult and embryonic stem-cell therapy. Embryonic stem cells are caught up in political and technological issues, and research is running well behind adult stem-cell therapy."

He was "delighted" with the Australian Government's endorsement and support for developing adult stem cells as novel therapeutic strategies in patients.

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