International Stem Cell's human cornea technology: Clinical-commercial opportunities in Asia and Europe

International Stem Cell Corporation (OTCBB: ISCO), www.intlstemcell.com, announced today that multiple international meetings taking place between ISCO’s executive management and researchers and clinicians from commercial entities in both Asia and Europe revealed significant clinical-commercial opportunities for the company’s stem cell-derived human cornea technology in those regions.

ISCO has discovered and filed for patents on a cell culture process for the synthesis of fully human, cornea-like structures using either its proprietary human parthenogenic stem cell (hpSC) technology or human embryonic stem cells. The structures are grown to clear hollow spheres with a size of 8-10 mm in diameter and contain tissues and cells similar to those found in normal human corneal tissue. Portions or all of these structures may be suitable for cornea transplantation in humans. Permeability and ocular histology testing has demonstrated compatibility with natural corneas. Future steps include scale-up of the manufacturing process and IND-enabling studies, to be conducted domestically and through international collaborations.

Cornea-related loss or reduction of vision can be caused by physical injuries, infections and a range of degenerative diseases that affect up to 10 million people worldwide. ISCO’s corneal structure may fit into existing medical applications where the surgical techniques are well established. Cornea transplantation has been refined greatly and is now typically performed as a one-two hour outpatient procedure using donated corneas from human cadavers. While most operations previously involved the entire corneal structure it is now common to selectively replace solely the damaged portion.

ISCO’s parthenogenic stem cell technology enables synthesis of corneal tissue that is immune matched for millions of people. This may significantly reduce the rejection rates of 15-30% experienced in current medical practice.

In the US 52,487 transplantations were performed in 2008. However, a shortage of corneal tissue has been a significant problem in much of the rest of the world. Only 3,000-4,000 procedures were performed annually in the UK and Germany due to limited cornea supply. In Asia, the shortage of corneas has been an even greater problem. For example, in Japan during a ten-year period only 16,000 transplantations were performed. China has had over 2 million patients on waiting lists yet only a few thousand procedures have been performed annually. Over 3 million Indians are reported to be blind due to corneal defects.

Dr Radhika Tandon, Professor of Ophthalmology and Officer-in-charge at the National Eye Bank, All India Institute of Medical Sciences (AIIMS) in New Delhi says: “Corneal vision impairment is a large medical problem in India and other developing countries. India has access to less than 20,000 suitable corneas per year yet would need 200,000 corneas to take care of the existing backlog and the new cases added each year. Supply of synthetic human corneas would alleviate the problem and provide great socio-economic benefit by enabling millions of Indians to get back to work and live a more normal life.”

Brian Lundstrom, ISCO’s President, says: “Given the substantial unmet medical need for human corneas in Asia and Europe, ISCO has commenced a targeted effort to partner with clinical development and commercialization partners in these regions. We believe clinical development in this area is particularly attractive given the rapid and hard end points of vision restoration, large available patient pools and modest competition from alternative technologies, particularly such involving live corneas.”