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Pathfinder Cells Stimulate Improved Kidney Function and Facilitate Repair of Kidney Tissue Damage Following Acute Kidney Injury

4/2/2013 3:24:56 PM

CAMBRIDGE, Mass., April 2, 2013 /PRNewswire/ -- Pathfinder Cell Therapy, Inc. ("Pathfinder") (OTCQB: PFND), a biotechnology company focused on the treatment of diseases characterized by organ-specific cell damage, today announced publication of groundbreaking preclinical data demonstrating that the Company's unique cell-based therapy is able to regenerate and enable functional repair of damaged tissue even when extracted from a different species and tissue type. The results of the study, which examined ischemia reperfusion (I/R) injury in a mouse model of renal damage, are currently featured in the February 2013 issue of Rejuvenation Research (Vol. 16, Issue. 1) and available online.

This peer-reviewed journal article marks the second significant publication of data on the Company's proprietary Pathfinder Cells (PCs), which are a novel class of adult-derived cells that facilitate functional repair of host tissue. In the April 2010 issue of Rejuvenation Research, pre-clinical data demonstrated that PCs were able to completely reverse diabetes in a mouse model.

"The present study in I/R injury in combination with our past research in diabetes validates the use of PCs to regenerate damaged tissues and also offers a novel therapeutic intervention for repair of solid organ damage in situ," stated Paul G. Shiels, Ph.D., University of Glasgow, Glasgow, United Kingdom. "Particularly eye-opening is the fact that rat pancreas-derived PCs were able to enable the functional mitigation of I/R injury in a mouse model of renal damage. Despite the different species and tissue origin, FISH analysis demonstrated that the repaired tissue was overwhelmingly mouse in origin. This suggests that PCs possess the ability to act in a paracrine fashion, stimulating the host tissue to recover functionality. To our knowledge, this is the first demonstration of an adult cell type derived from pancreatic tissue fulfilling such a role and the first demonstration of this in a xenogenic setting."

To test the hypothesis that PCs may be able to facilitate repair in other organs, researchers used a well-established renal ischemia reperfusion injury mouse model in which female mice were subjected to 30 min of renal ischemia and then treated with intravenous injection of male rat pancreas-derived PCs or saline (control). Kidney function was assessed 14 days after treatment by measuring serum creatinine (SC) levels. Kidney tissue was assessed by immunohistochemistry (IHC) for markers of cellular damage, proliferation, and senescence (TUNEL, Ki67, p16ink4a, p21). Fluorescence in situ hybridization (FISH) was performed to determine the presence of any rat cells in the mouse tissue.

PC-treated animals demonstrated superior renal function at day 14 post-I/R, in comparison to saline-treated controls, as measured by SC levels (0.13 mg/dL vs. 0.23 mg/dL, p < 0.001). PC-treated kidney tissue expressed significantly lower levels of p16ink4a in comparison to the control group (p=0.009). FISH analysis demonstrated that the overwhelming majority of repaired kidney tissue was mouse in origin. Rat PCs were only detected at a frequency of 0.02%.

Richard L. Franklin, M.D., Ph.D., Founder, CEO and President of Pathfinder said, "The results of this study are groundbreaking in that it confirms the use of PCs is neither restricted to their tissue nor the species of origin. As a result, PC use may be applicable to a wide range of tissue damage. Additionally, the Company's research suggests that the mechanism of PC-mediated renal repair may be linked to the release of PC microsecretome-derived microvesicles and the associated transfer of microvesicle microRNA. Based on our knowledge of PC functionality, this pathway may be the key to fully realizing the potential of PCs in stimulating the repair and regeneration process in damaged tissue."

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 ("PCs") 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 tissues 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.

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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.

For Pathfinder Cell Therapy, Inc.:

Media / Investor Contacts:

Rick Franklin

Jason Rando / Claire Sojda

Tiberend Strategic Advisors, Inc.


SOURCE Pathfinder Cell Therapy, Inc.

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