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Mesoblast Cleared To Begin First Phase 2 Clinical Trial For Eye Diseases

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:

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