PFND Pathfinder Cell Therapy Inc (CE)

Pathfinder Cell Therapy, Inc. ("Pathfinder") (OTCQB:PFND), a biotechnology company focused on the treatment of diseases characterized by organ-specific cell damage, today provided a progress update on its research and development activities for the Company's proprietary Pathfinder Cells ("PCs"). In multiple animal models, Pathfinder has confirmed the ability of PCs to stimulate the natural regeneration of surrounding damaged tissues without the cells being incorporated into the newly generated tissue. These positive preliminary data support further development of PCs as a potential treatment for several important human diseases including diabetes, cardiac ischemia, and renal reperfusion injury.

Pathfinder's current R&D programs follow three tracks: 1) further exploring animal models to uncover the range of potential indications for which PCs may be effective; 2) elucidating the underlying mechanism by which PCs are able to regenerate damaged tissues; and 3) laying critical groundwork for securing a reliable and controllable tissue source for PCs and determining best practices for preparation, cell growth, storage and handling of PCs.

What are Pathfinder Cells?

Pathfinder Cells are a newly identified mammalian cell type discovered by Pathfinder that have the ability to stimulate tissue regeneration in a number of different organs. PCs are not stem cells and are distinguishable from cell types being developed by other companies for use in regenerative medicine through cell surface and other markers.

PCs can be found in a number of different organs, including the kidney, liver, pancreas, lymph nodes, myometrium, and placenta. Pathfinder has isolated PCs from humans and rats, and used cells derived from both sources successfully to regenerate damaged tissue in mice without the PCs being incorporated into the newly generated tissue. This remarkable phenomenon indicates that PCs appear to be "immune privileged," and therefore may be able to be used between immunologically different individuals.

Evaluating Potential Indications for Clinical Development

Pathfinder has made significant progress in exploring the therapeutic potential of PCs through the use of animal models. Determining the specific indications for which PCs demonstrate efficacy will help identify the appropriate indication(s) that should be targeted for human clinical studies.

The company announced previously that it had demonstrated positive preliminary results from animal studies representing important human conditions including diabetes, myocardial infarction (cardiac ischemia), and renal reperfusion injury. In the last 12 months, Pathfinder was able to confirm these key findings in all three disease models, demonstrating the breadth of potential indications where PC-based therapy may be efficacious.

In March 2011, Pathfinder announced the publication of compelling mouse data in the peer-reviewed scientific journal Rejuvenation Research. The study showed that PCs were effective at regenerating critically damaged tissue in the common Streptozotocin (STZ)-induced diabetic mouse model. Ultimately, the data demonstrated that the Company's unique cell-based therapy was able to completely reverse diabetes in this particular disease model in mice. The Company is in the process of preparing manuscripts describing the results for myocardial infarction and renal reperfusion injury and plans to submit these findings for potential publication in peer-reviewed journals in the near future.

In parallel with these confirmatory studies, Pathfinder has continued testing PCs for the potential treatment of other diseases that involve organ-specific cell damage. The Company is in the early stages of examining PCs for the treatment of critical limb ischemia in a mouse model as well as in a rat model of osteoarthritis. Preliminary data from these studies have been encouraging.

Exploring Potential Mechanisms of Action

While treatment with PCs has shown broad efficacy in animal models, the mechanisms through which PCs stimulate regeneration of surrounding tissue are not yet fully understood. PCs appear to produce microvesicles in vivo, which are released by the PCs extracellularly where they can contact and enter surrounding cells. Pathfinder has been examining these microvesicles produced by both rat and human PCs, as well as the microRNA contained in those microvesicles. Through these studies, researchers have been successful in identifying a small number of conserved molecules, which appear to target a limited number of pathways. Based on the nature of these pathways, these findings are consistent with the effects seen previously in animal studies.

While encouraged by the progress made to date, Pathfinder's R&D team is continuing to characterize PCs in order to better understand the therapeutic mechanisms. A deep understanding of how PCs stimulate tissue regeneration is critical for designing cell-based therapies with the potential to impact the treatment of human diseases.

Investigating Controllable Sources and Improved Bioprocessing Systems

Although PCs are in early-stage development, Pathfinder's ability to source and grow PCs reliably and at an increased scale will be critical to the Company's ability to generate commercially viable PC-based products in the future. This is true of any development-stage cell-based therapy and it can be a lengthy process. Pathfinder is committed to investigating the most efficient and reliable manufacturing solutions in order to maximize the potential of PCs.

While PCs have been found in the pancreas, kidney, and other organs, some of these tissues are not readily available from controllable sources. For this reason, alternative sources must be identified and developed for commercial-scale production. Pathfinder is currently investigating PCs isolated from human placenta, cord blood, tonsil, and myometrium. The evaluation process begins with tissue collection, and then isolating PCs and growing them in culture. Because PCs are more difficult to grow than some other mammalian cell types, including mesenchymal stem cells, Pathfinder is also investigating a number of technologies that may increase the growth potential of PCs under laboratory conditions. Once enough PCs have been generated, their activity must be evaluated and confirmed by testing in validated animal models. Pathfinder is currently using the STZ-induced diabetic mouse model as a standard reference assay for these tests.

Once these elements are in place, Pathfinder intends to initiate large-scale good manufacturing practices (GMP) production in preparation for toxicology studies and clinical trials. The Company plans to provide updates on these plans as appropriate.

About Pathfinder Cell Therapy, Inc.

Pathfinder is developing a novel cell-based therapy with the potential to transform the treatment of diabetes, renal disease, myocardial infarction, and other diseases characterized by organ-specific cell damage. Leveraging its internal discovery of Pathfinder Cells, and a proprietary means of isolating these cells from surrounding tissue, Pathfinder is pioneering a new field in regenerative medicine. PCs are a newly identified mammalian cell type present in very low quantities in a variety of different organs, including the kidney, liver, pancreas, lymph nodes, and other tissues.

Early studies indicate that PCs stimulate regeneration of damaged tissue without the cells themselves being incorporated into the new tissue. The cells appear to be "immune privileged," and their effects are independent of the tissue source of PCs. PCs isolated from both rat and human tissue sources have shown efficacy in animal models of diabetes, cardiac ischemia, and renal reperfusion injury.

For more information please visit: www.pathfindercelltherapy.com

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, risks related to regulatory approvals and the success of Pathfinder's ongoing and future studies, including the success of PCs, and uncertainties relating to the availability of capital to support Pathfinder's research, development and potential product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies. These and other risks and uncertainties are identified and described in more detail in the Company's filings with the Securities and Exchange Commission including the definitive proxy statement filed on July 26, 2011. The Company undertakes no obligation to publicly update or revise any forward-looking statements.

CONTACT: The Ruth Group
         Joshua Drumm (investors) / Victoria Aguiar (media)
         (646) 536-7006 / (646) 536-7013
         jdrumm@theruthgroup.com / vaguiar@theruthgroup.com
         
         Rick Franklin
         CEO, Pathfinder LLC
         Rick.Franklin@PathfinderCellTherapy.com