OCEANSIDE, CA – May 18, 2010 – International Stem Cell Corporation (ISCO.OB), www.intlstemcell.com, announced today that it had entered into a strategic alliance with The Automation Partnership (TAP), www.automationpartnership.com, to automate and scale up the production of stem cell-derived human corneal tissue. The alliance has been formed to create instrumentation for ISCO and its partners and affiliates to produce development and commercial volumes of donor tissue for cornea transplantation and to reduce the use of animals and animal eyes in safety testing of drugs, chemicals and consumer products.
Cornea-related loss or reduction of vision can be caused by physical injury, infections and degenerative diseases. In cases where cornea replacement is indicated, current medical practice typically involves a one-two hour outpatient procedure under local anesthesia using full or partial corneas from healthy human cadavers. 10 million people worldwide are candidates for such treatment, primarily in Asia and Europe where there is significant quantitative and qualitative shortage of human cornea donation.
Global efforts are underway to transition from the use of live animals and excised animal eyes to test drugs, chemicals and consumer products. For example, Europe’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) estimates a need to spend €270M and use 160,000 animals for eye safety testing alone to catch up with the back-log of insufficiently tested agents. In the US, the National Institutes of Health (NIH) and the Environmental Protection Agency (EPA) have launched a five-year program dedicated to finding new, non-animal technologies for toxicity testing of chemical compounds.
ISCO has discovered and filed for patents on a cell culture process for the synthesis of standardized, human, corneal tissue using stem cells. Histology, permeability and optical testing has demonstrated compatibility with natural corneas. Efforts are ongoing to further characterize this tissue and standardize and scale up its synthesis. Automation is necessary to produce sufficient, reproducible tissue for development and commercialization of the therapeutic and toxicity testing applications.
Brian Lundstrom, ISCO’s President, says: “Given the substantial unmet therapeutic and toxicology testing needs for human corneal tissue, ISCO has embarked on a focused effort to advance this technology with international investors, eye clinics, and development and commercialization partners. After reviewing a range of potential cell culture automation companies, we are very pleased that TAP has agreed to contribute their over twenty years of experience towards this goal.”
David Newble, TAP’s CEO says: “TAP has successfully installed and supported over 160 automated cell culture systems worldwide and continues to design new and customize existing equipment for cell culture and other emerging life science applications. The opportunity to join forces with ISCO in the cornea tissue area will enable us to contribute solutions for clear biomedical needs while also creating new technology and knowhow that will be useful in other applications downstream.”
ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells (hpSCs) from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO’s website, www.internationalstemcell.com
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About The Automation Partnership
The Automation Partnership (TAP) provides advanced automation systems and services to improve productivity in life science research, development and production.
For over 20 years TAP has been the leader in the design and development of automated cell culture and processing systems with applications in regenerative medicine, discovery research, bioprocess development and biologics production. Systems include SelecT, CompacT SelecT and Cellmate.
In addition, TAP has a strong track record in providing a range of custom automation solutions for biobanking, biological sample management, compound management and advanced high throughput screening applications.
TAP is a privately-owned company with headquarters near Cambridge, UK and a sales and support facility near Wilmington, Delaware, USA.
Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "should," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.
Key Words: Stem Cells, Biotechnology, Parthenogenesis
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
Brian Lundstrom, President
The Automation Partnership
Head of Communications
+44 1763 227 200