Pathfinder Cells Demonstrate Ability to Regenerate Damaged Tissue and Restore Pancreatic Function in a Diabetic Mouse Model

CAMBRIDGE, Mass., March 29, 2011 /PRNewswire/ -- Pathfinder, LLC, a private biotechnology company focused on the treatment of diseases characterized by organ-specific cell damage ("Pathfinder"), today announced publication of promising preclinical data demonstrating that the Company's unique cell-based therapy is able to completely reverse diabetes in a mouse model.  The results of the study, which will be printed in the April issue of Rejuvenation Research and available currently online, are the first to describe the Company's proprietary Pathfinder Cells ("PCs"), which stimulate regeneration of damaged tissues without the cells themselves being incorporated into the newly generated tissue.

"Though preliminary, the robustness of these results is very encouraging," stated Paul G. Shiels, Ph.D., University of Glasgow, Glasgow, United Kingdom. "With only two treatments with PCs, just days after induction of diabetes, we were able to quickly regenerate critically damaged pancreatic tissue, restoring and maintaining normal glucose levels and healthy body weight.  Importantly, these results enhance our understanding of the mechanisms of self-repair elicited by PCs, which may represent a novel cell therapy-based approach to treating diseases marked by tissue damage and loss of organ function."

Richard L. Franklin, M.D., Ph.D., Founder, CEO and President of Pathfinder said, "We are pleased to share our preliminary findings for this exciting new cell-based technology.  We will continue to focus our efforts on elucidating the mechanism by which PCs stimulate tissue regeneration, as well as explore the potential use of such therapy in treating diseases with high unmet need such as diabetes, cardiac ischemia, and renal reperfusion injury."

The efficacy of PC treatment was examined using the common streptozotocin (STZ)-induced diabetic mouse model.  At three and ten days following administration of STZ, which destroys insulin-producing beta-cells, 1.5 million human or rat pancreas-derived PCs were injected into mice intravenously.  As early as day nine, animals treated with rat or human PCs had significantly lower blood glucose than control animals (p<0.01).  Animals in the control group became profoundly diabetic within one week following STZ administration, while PC-treated mice showed a progressive reduction in blood glucose, achieving normal levels by day 39 and maintaining these levels with no further treatment through day 89, at which point the study was terminated.  Concurrent with the restoration of normal glucose levels, PC-treated animals recovered from an initial loss of body mass and maintained normal body weight for the remainder of the study.

Immunohistochemical analyses of animal tissues confirmed that PC treatment lead to regeneration of pancreatic beta-cells and formation of functional islets, which displayed normal architecture.  Further examination determined that the regenerated islets consisted overwhelmingly of mouse cells, and to a much lesser extent, donor PCs (0.05-0.18%).  The few PCs present in the islet tissue were diffused throughout sections, indicating that the PCs themselves do not form islet-like structures in vivo.  Importantly, this strongly suggests that PCs activate mechanism(s) in the host that drive pancreatic islet regeneration, but which are not capable of initiating such repair in the absence of PCs.

Dr. Franklin concluded, "These data indicate the feasibility of using PCs to stimulate the regeneration of critically damaged adult tissue.  The further development of PCs as a vehicle for regenerative medicine offers exciting prospects for future therapies."

About Pathfinder

Pathfinder is developing a novel cell-based therapy with the potential to revolutionize 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 organs, including the kidney, liver, pancreas, lymph nodes, myometrium, bone marrow and blood.

Early studies indicate that PCs stimulate regeneration of damaged tissues without the cells themselves being incorporated into the newly generated tissue.  Based on testing to date, the cells appear to be "immune privileged," and their effects appear to be independent of the tissue source of PCs.   In addition to diabetes, positive results have been observed in animal models of cardiac ischemia and renal reperfusion injury.  For more information please visit: www.pathfindercelltherapy.com.  

In December 2010, Pathfinder and SyntheMed, Inc. (OTC Bulletin Board: SYMD) announced that the companies had entered into a definitive merger agreement.  Upon closing, SyntheMed will be renamed  "Pathfinder Cell Therapy, Inc." and the combined company will operate under the leadership of the Pathfinder management team, with the support of a group of regenerative medicine thought leaders on the board of directors.  Closing of the merger is subject to a number of conditions.  For more information please visit: http://www.prnewswire.com/news-releases/pathfinder-llc-and-synthemed-inc-announce-merger-agreement-112334759.html.

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, our inability to obtain additional required financing; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results, if any; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; technological changes; and government regulation. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

For more information, please contact:

The Ruth Group
Joshua Drumm (investors) / Jason Rando (media)
(646) 536-7006 / (646) 536-7025
[email protected] / [email protected]

Rick Franklin
CEO, Pathfinder LLC
[email protected]

SOURCE Pathfinder, LLC