Mesoblast Reports Positive Type 2 Diabetes Trial Results
December 03 2013 - 7:10PM
Regenerative medicine company Mesoblast Limited (ASX:MSB;
USOTC:MBLTY) today announced top-line results from the Phase 2
trial of its proprietary Mesenchymal Precursor Cells (MPCs) in
subjects with type 2 diabetes. The results of the trial support the
safety and tolerability of a single intravenous infusion of MPCs in
type 2 diabetes. Additionally, there was an improvement in glycemic
control as evidenced by reduction in hemoglobin A1c (HbA1c). The
Phase 2 randomized, single-blind, placebo-controlled, dose
escalation trial was conducted across 18 sites in the United
States. The trial evaluated the effects of a single intravenous
infusion of 0.3, 1.0 or 2.0 million MPCs/kg or placebo over 12
weeks in 61 patients with a mean diabetes duration of 10 years. Key
positive findings were:
- The MPCs were safe and well tolerated with no treatment-related
adverse events, meeting the trial's primary endpoint.
- Following a single intravenous MPC infusion, overall HbA1c
levels were reduced over the 12-week study period when compared to
placebo.
- The highest dose showed the greatest overall reduction in
HbA1c, with a peak decrease of 0.4% at 8 weeks compared with
placebo (p less than 0.05), and a decrease of 0.3% at 12
weeks.
- In the less well-controlled subjects, as defined by a baseline
HbA1c greater than or equal to 8.0%, a 0.6% decrease in HbA1c was
seen at 8 weeks in the high dose cohort compared with placebo.
- In those with baseline HbA1c less than 8%, a target of HbA1c
less than 7% at week 12 was achieved in 63% (5/8) of high-dose
treated subjects compared with 0/7 placebo controls (p less than
0.05).
Mesoblast Chief Executive Silviu Itescu said: "We are very
pleased and encouraged by these top-line results. In this phase 2
trial, a single injection of Mesoblast's MPCs was well tolerated
and showed evidence of improved glycemic control in type 2
diabetes, a chronic inflammatory disease affecting multiple organs.
"This is an important first step in developing an MPC-based
immunomodulatory therapy for the treatment of type 2 diabetes and
its complications." According to the World Health Organization,
there are more than 347 million people worldwide with diabetes and
the number is likely to more than double by 2030 without
intervention. In the United States alone, according to the
American Diabetes Association there were 18.8 million people
suffering from type 2 diabetes in 2011. According to the United
States Food and Drug Administration Guidance for Industry 2008,
HbA1c is the primary endpoint of choice for glycemic control in
subjects with type 2 diabetes. About Mesoblast
Mesoblast Limited (ASX: MSB; USOTC: MBLTY) is a world leader in
the development of biologic products for the broad field of
regenerative medicine. The Company's proprietary technologies
include its Mesenchymal Precursor Cell and culture-expanded
Mesenchymal Stem Cell technology platforms, Dental Pulp Stem Cells
and expanded Hematopoietic Stem Cells. Mesoblast's allogeneic or
'off-the-shelf' regenerative medicine products are being developed
for the treatment of conditions with significant unmet medical
needs. The lead product candidates use its mesenchymal lineage
cells in four major and distinct areas - systemic inflammatory
conditions, cardiovascular diseases, orthopedic diseases of the
spine, and oncology conditions. www.mesoblast.com
CONTACT: For further information, please contact:
Julie Meldrum
Corporate Communications
Mesoblast Limited
T: +61 (0) 3 9639 6036
E: julie.meldrum@mesoblast.com
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