Positive FDA meeting speeds Mesoblast trials

Melbourne-based Mesoblast (ASX:MSB) has accelerated its clinical program for obtaining regulatory approvals for its adult stem cell platform technology following a successful pre-investigational new drug (IND) meeting with the US FDA.

"Adult stem cells are real therapy today -- the research has been done -- adult stem cells are here and we are looking for short term benefits to the community," said Mesoblast executive chairman, Michael Spooner.

Mesoblast is investigating the use of its unique stem cell technology for the treatment of a range of orthopaedic conditions. It uses a proprietary platform technology to isolate adult stem cells. These cells are expanded to produce potentially hundreds or thousands of clinical doses which may be implanted into unrelated recipient patients, regenerating bone and cartilage.

"The company is preparing submissions for five market opportunities, including the repair of long bone fractures and spinal fusion - they are on track and are due to be filed late 2006," he said.

Mesoblast founder and chief scientific advisor Professor Silviu Itescu said in a statement that as a result of the recent discussions with the FDA the company's new clinical strategy will be to proceed directly to proof-of-concept phase II trials for each orthopaedic indication in order to establish a safe, effective stem cell dose for phase III multi-centre registration trials.

"While the FDA will review each IND submission on a case by case basis, an accelerated commercialisation program will likely apply to all orthopaedic indications using Mesoblast's unique adult stem cell platform technology," Spooner continued.

He believes the accelerated program has many advantages for Mesoblast and its shareholders, "The effect will be to enable the company to dramatically reduce both time and costs associated with product commercialisation. This will translate into a reduction of many years of work and a saving of millions of dollars over the entire commercialisation program," he said.

Mesoblast will now proceed with its first human orthopaedic trial at Royal Melbourne Hospital which is due to commence in 4-6 weeks. The trial will include the study of up to 10 patients suffering from non-union of long bone fractures and will test safety of Mesoblast's adult stem cell technology.

A second pilot study, which will include up to 10 patients with multi-coronary vessel disease, is expected to commence before the end of the year at Newcastle's John Hunter Hospital. A series of large animal dose-escalation studies for long bone fractures and intervertebral spinal fusion is also underway in the US at Colorado State University.

"Results from these trials will become an important part of our IND submission," said Spooner.