Mesoblast's NeoFuse Stem Cell Product Shows Positive Results in Phase 2 Lumbar Spinal Fusion Trial

Mesoblast's NeoFuse Stem Cell Product Shows Positive Results in Phase 2 Lumbar
Spinal Fusion Trial

Results Support Progression of Clinical Development to Phase 3

Key points:

  *Phase 2 trial results using Mesoblast's allogeneic, or "off-the-shelf",
    Mesenchymal Precursor Cells (MPCs) demonstrated rates of fusion success
    that were comparable to the gold standard bone autograft
  *MPCs were well tolerated with no cell-related serious adverse events and
    no evidence of any ectopic bone formation
  *At 12 months, fusion was achieved in 85.7% and 62.5% of patients in the
    low and high MPC treatment groups compared to 75% of patients who received
    bone autograft
  *Significant improvements in low back pain scores and total disability
    index were seen in both MPC groups and were comparable to those receiving
    bone autograft
  *Those receiving MPCs had 30-43% less blood loss during the surgical
    procedure than those receiving bone autograft (p less than 0.05)
  *These results indicate that lumbar vertebral fusion using allogeneic MPCs
    is as effective as bone autograft
  *Eliminating the need for an autograft bone harvest will avoid the risks of
    this procedure, including pain, infection and blood loss.

MELBOURNE, Australia, Jan. 11, 2013 (GLOBE NEWSWIRE) -- Regenerative medicine
company Mesoblast Limited (ASX:MSB) (USOTC:MBLTY) today announced that its
Phase 2 clinical trial for lumbar spinal fusion had successfully met its
safety and efficacy endpoints.

The results suggest that Mesoblast's NeoFuse product comprising allogeneic
Mesenchymal Precursor Cells (MPCs) is as effective for interbody lumbar fusion
as the gold standard, bone autograft, without the need for a second surgical
procedure and its attendant morbidity risks. These results support the
progression of clinical development of NeoFuse to a Phase 3 trial ininterbody
lumbar fusion.

The results were highlighted during a presentation to the 31 st annual JP
Morgan Healthcare Conference in San Francisco by Mesoblast Chief Executive
Professor Silviu Itescu.

Twenty four (24) patients were enrolled and randomized over 5 sites in the
United States with 8 patients in each treatment arm – bone autograft standard
of care (Control), 25 million MPCs (25M), and 75 million MPCs (75M). Patients
underwent the surgical procedure, one or two level fusions using a posterior
approach to the spine, and were evaluated for safety and efficacy. The median
follow-up times for the three treatment groups were 23.9, 20.7, and 22.9
months for the bone autograft, 25M, and 75M groups, respectively.

MPCs were well tolerated with no cell-related serious adverse events and no
ectopic bone formation at all. Notably, MPC treated groups had 30-43% lower
mean estimated blood loss during surgery compared to the autograft treatment
group (pless than 0.05 for the 25M group).

At 12 months, fusion was achieved in 85.7% of patients in the 25M treatment
group compared to 62.5% in the 75M and 75% in the control patient groups.
Overall, patients from all three treatment groups had a clinically significant
and comparable decrease in low back and leg pain, assessed on the Visual
Analogue Scale and functional improvement, assessed by the Oswestry Disability
Index questionnaire.

Dr Randall Dryer, an orthopedic surgeon with the Central Texas Spine Institute
and an investigator in Mesoblast's study, said: "For patients whose spinal
discs have degenerated too extensively for repair, bony fusion of adjacent
vertebra is the primary option to eliminate chronic and debilitating pain.

"Other than autograft, there is no approved product for posterior spinal
fusion, a surgical approach which accounts for 62% of all lumbar fusion
procedures. There is a critical unmet need for new technologies to achieve
fusion that are safe, effective, and that eliminate the need for bone
autograft.

"Based upon my experience in the Phase 2 study, Mesoblast's cells may provide
a significant and valuable option to achieve fusion in patients with severe
spinal disc degeneration and these results warrant progressing to a Phase 3
study," Dr Dryer added.

According to Millennium Research Group, in the United States there were
approximately 380,000 lumbar spinal fusion procedures performed in 2012. They
estimate the overall worldwide market for bone graft substitutes to be nearly
$1.6 billion dollars in 2012 with the majority of bone graft revenues,
approximately 70%, coming from spinal fusion procedures.

Mesoblast plans to initiate a Phase 3 trial for interbody lumbar fusion later
this year, with patients to be enrolled across multiple sites in the United
States, Europe and Australia.

Mesoblast Limited

Mesoblast Limited is a world leader in the development, manufacture, and
commercialization of biologic products for the broad field of regenerative
medicine. Mesoblast's patented Mesenchymal Precursor Cell (MPC) technology is
being developed for a broad range of major clinical diseases, including
inflammatory and immunologic conditions, diabetes and its complications,
orthopedic spine conditions, and cardiovascular disorders. www.mesoblast.com

CONTACT: Julie Meldrum
         Global Head of Corporate Communications
         T: + 61 (0) 3 9639 6036
         E: julie.meldrum@mesoblast.com
 
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