MELBOURNE, Australia,
Oct. 24, 2011 /PRNewswire/ --
Key Points
- Mesoblast receives regulatory clearance to begin Phase 2 trial
for wet Age-related Macular Degeneration (AMD)
- Trial will be performed at Singapore National Eye Centre,
combining Mesoblast's allogeneic ("off-the-shelf") cells with
anti-VEGF agent
- Wet AMD, the leading cause of blindness in industrialized
countries, has different forms in Asia and North
America/Europe
- Anti-VEGF agents are less effective in Asian form of wet
AMD
- Mesoblast's allogeneic cells may be effective for both Asian
and North American/European forms of wet AMD
- Commencing this trial in Singapore is in line with Mesoblast's evolving
clinical and manufacturing strategies
Regenerative medicine company Mesoblast Limited (ASX: MSB) today
announced that it has received regulatory clearance from the
Singapore Health Sciences Authority (HSA) to commence the first
Phase 2 trial of its proprietary allogeneic (off-the-shelf) adult
stem cell therapy for patients with proliferation of leaky blood
vessels in the eyes – neovascular ("wet") Age-related Macular
Degeneration (AMD). Wet AMD causes sudden and severe central vision
loss and accounts for approximately 90 percent of all blindness in
the elderly. Mesoblast is developing a stem cell therapeutic
product for treating various vascular diseases of the eye,
including wet AMD and diabetic macular edema (DME).
In North America, the
prevalence of wet AMD is estimated to grow to nearly 3 million by
2020, from 1.7 million today, with about 200,000 new cases
diagnosed each year. The current standard-of-care for wet AMD in
North America is repeated
intraocular injections using an anti-vascular endothelial growth
factor (anti-VEGF) agent, such as Lucentis and Avastin. However,
treatment needs to be maintained long-term since cessation of
repeated injections results in rapid disease recurrence and risk of
vision loss.
In Asia, wet AMD affects as
many as 1.9% of people 65 or older. However, up to 55% of cases of
wet AMD in Chinese, Japanese, and Malay populations are caused by
Polypoid Choroidal Vasculopathy (PCV), a disorder of eye blood
vessel proliferation that is different from the wet form seen in
North America and Europe. Anti-VEGF therapy does not result in
adequate regression of PCV lesions, and for this reason first line
therapy for PCV is photodynamic therapy.
Mesoblast's proprietary adult stem cells may be effective for
both forms of wet AMD since they have successfully reduced
excessive blood vessel formation and leakiness in several
preclinical studies:
1. Results from a study at the Lions' Eye Institute in
Western Australia in 30 rodents
with laser-induced excessive blood vessel formation showed that a
single intra-ocular injection of human MPC prevented development of
leaky blood vessels beyond day 7 after laser-induced damage (eyes
treated with MPC had 39% and 32% non-leaky vessels at days 14 and
28, compared with only 7% and 2% non-leaky vessels in the controls
at the same time-points, p
