Promising alternative to use of live animals for drug testing

International Stem Cell Corporation (OTCBB:ISCO)(www.internationalstemcell.com), the first company to perfect a method of creating human “parthenogenetic” stem cells from unfertilized eggs, announces positive results of its collaboration with Absorption Systems to study ISCO’s stem-cell-derived human corneal tissue as an alternative to live animals for drug testing. Initial results using non-animal or “in vitro” tests indicate an excellent correlation between the rates at which drugs pass through ISCO’s lab-grown corneal tissue and rabbit corneal tissue. The results offer great promise for reducing the use of living animals for eye safety testing. ISCO’s human corneal tissue is created from parthenogenetic stem cells in the laboratories of Lifeline Cell Technology (Walkersville, MD), ISCO’s wholly-owned subsidiary.

According to Dr. Chris Bode of Absorption Systems. “The rank order correlation of the eight drugs tested so far is almost perfect.”

The collaboration between the companies is focused on using Absorption Systems’ know-how in creating assay systems to develop superior preclinical methods of testing drugs. Such methods can also reduce the use of laboratory animals currently necessary for other tests, including the very large global commercial need for a reliable and reproducible non-animal method for eye safety testing of consumer products.

In the past, researchers have grown corneal cells in the laboratory, but ISCO is believed to be the only company to grow a self-assembling corneal construct from parthenogenetic stem cells that is suitable for toxicity testing and possibly suitable for corneal transplants. ISCO’s corneal constructs include cell layers and structures normally found in a human cornea, as confirmed by an independent third-party laboratory. ISCO’s proprietary lines of parthenogenetic stem cells remove the need for fertilized embryos and, in a therapeutic setting, may minimize the threat of immune rejection. This breakthrough was published in the peer-reviewed journal Cloning & Stem Cells (Volume 9, Number 3; September 2007:432-449 and, Volume 10, Number 1; March 2008: 11-24).

“These initial experiments are very encouraging and will be followed up with more extensive testing. Absorption Systems’ proficiency in performing tissue-based assays may provide a powerful and unique drug testing model for the large commercial markets in the pharmaceutical industry and the field of ophthalmology,” commented Jeffrey Janus, Senior VP of ISCO and CEO of Lifeline. “In addition, this work complements ISCO’s effort to use its parthenogenetic stem cells to create cell transplant therapies for diseases of the eye. We plan to further develop our corneal tissue technology with a goal of routinely growing living human corneas for ultimate use in human corneal transplants.”

“ISCO’s corneal construct, combined with Absorption Systems’ expertise in assessing drug disposition, may provide pharmaceutical and ophthalmology researchers with new insight, without the need for animal models,” said Patrick M. Dentinger, President and CEO of Absorption Systems. “Absorption Systems’ services yield the type of definitive data expected by the FDA, so we believe that our combined products will be of great interest to researchers studying diseases of the eye.”

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