Cell-enriched primary renal cells improve survival and augment kidney function in CKD rodents

Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, announced today the publication of a key study in the American Journal of Physiology Renal Physiology by researchers at Tengion. In the study, rodents with chronic kidney disease (CKD) were treated with healthy kidney cells to catalyze the regeneration of functional kidney tissue and delay disease progression, as evidenced by extended survival, improved kidney filtration, and reduced severity of kidney tissue pathology.

The published data demonstrate that delivery of a selected population of kidney cells to the kidney significantly extended long-term survival and improved kidney function in rodents with chronic kidney disease during six months of follow-up. Further, the therapeutic effects reported in this study were more pronounced and more durable than have been previously reported with this animal model.

"These data provide in-vivo proof-of-concept for a potentially transformational approach to preventing kidney failure," said Steven Nichtberger, M.D., president and CEO of Tengion. "Based on these data, over the past two years, Tengion scientists have worked with leaders in the field to design and initiate multiple studies evaluating the ability of our Neo-Kidney Augment™ product candidate to prevent kidney failure across a variety of chronic kidney disease models, including large mammals. We look forward to presenting initial scientific findings from these studies in the near future."  

"Chronic kidney disease is a serious medical condition affecting millions of Americans and can lead to kidney failure requiring the need for transplant or lifelong dialysis," said David Gerber, M.D., an advisor to Tengion and Chief, Division of Transplantation, Department of Surgery, University of North Carolina. "A treatment approach that can increase kidney tissue and improve function would be a significant advancement in the care of these patients."  

"The scientific community has historically considered that CKD develops from an imbalance between tissue damage and the kidney's ability to repair and regenerate itself," said Rusty Kelley, Ph.D., Senior Scientist at Tengion and the lead study author. "These preclinical data provide clear evidence that regeneration of functional renal tissue can delay progression of CKD."

Tengion's Neo−Kidney Augment product candidate is designed to prevent or delay the need for dialysis or kidney transplant in patients with progressive CKD by enhancing functional kidney mass. By using the patient's own kidney cells, procured by a needle biopsy, the Company is developing a product candidate that is implanted into the failing kidney and catalyzes the regeneration of functional kidney tissue. Tengion will provide additional information on its product development plans to investors today at the Rodman & Renshaw Healthcare Conference and slides from that presentation will be available on the Company's website.  The Company also expects to share new data from an ongoing study of the Neo-Kidney Augment in a diabetic, obese, hypertensive animal model of renal failure at a meeting of the International Society for Cellular Therapy on September 28, 2010 in San Francisco and to announce the initial results from a study of large animals in the fourth quarter of 2010.

The paper entitled, "A tubular cell-enriched subpopulation of primary renal cells improves survival and augments kidney function in a rodent model of chronic kidney disease," is available online at the American Journal of Physiology Renal Physiology website - http://ajprenal.physiology.org/cgi/content/abstract/ajprenal.00221.2010v1 - and will appear in the November 2010 print issue.