Regenerative Cellular Therapy in Chronic Kidney Disease Extends Survival; Tengion Preclinical Study Published in American Journal of Physiology Renal Physiology

EAST NORRITON, Pa., Sept. 13 /PRNewswire/ -- 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.

About Chronic Kidney Disease (CKD)

According to the National Kidney Foundation, chronic kidney disease affects over 26 million people in the U.S. and frequently develops as a result of diabetes and hypertension.  Patients with progressive CKD ultimately receive dialysis for blood filtration and a complex drug regimen to manage co-morbidities. While most patients with advanced CKD would benefit from a kidney transplant, the number of available healthy organs is vastly insufficient to meet the need.

About Tengion

Tengion, a clinical-stage biotechnology company, has pioneered the Organ Regeneration Platform™ that enables the Company to create proprietary product candidates that are intended to harness the intrinsic regenerative pathways of the body to produce a range of native-like organs and tissues. Tengion's product candidates seek to eliminate the need to utilize other tissues of the body for a purpose to which they are poorly suited, procure donor organs or administer anti-rejection medications. Tengion commenced a Phase I clinical trial in the first half of 2010 for its lead product candidate, the Neo-Urinary Conduit, an autologous implant that is intended to catalyze regeneration of native-like bladder tissue for bladder cancer patients requiring a urinary diversion following bladder removal. Tengion has also applied its technology in two Phase II clinical trials for Tengion's Neo-Bladder Augment™ for the treatment of neurogenic bladder and is in preclinical development of its Neo-Kidney Augment™. Tengion has worldwide rights to its product candidates.

Forward-Looking Statements

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to the Company's: (i) plans to develop and commercialize its product candidates, including the Neo-Kidney Augment and the Neo-Urinary Conduit; and (ii) expectations regarding ongoing and planned preclinical studies and clinical trials. Although Tengion believes that these statements are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there are a number of factors that may cause actual results to differ from these statements. For instance there can be no assurance that: (i) the Company will be able to obtain the capital it needs to develop its product candidates or continue as a going concern; (ii) the Company will be able to successfully enroll patients in its clinical trials, including its  Phase I clinical trial for the Neo-Urinary Conduit; (iii) patients enrolled in the Company's clinical trials will not experience adverse events related to the Company's product candidates, which could delay clinical trials or cause the Company to terminate the development of a product candidate; (iv) the results of the clinical trial for the Neo-Urinary Conduit will support further development of that product candidate; (v) data from our ongoing preclinical studies will continue to be supportive of advancing our preclinical product candidates; and (vi) the Company will be able to progress its product candidates that are undergoing preclinical testing, including the Neo-Kidney Augment, into clinical trials.  For additional factors which could cause actual results to differ from expectations, reference is made to the reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended.  The forward looking statements in this release are made only as of the date hereof and the company disclaims any intention or responsibility for updating predictions or expectations in this release.

SOURCE Tengion, Inc.