EAST NORRITON, Pa., March 23, 2011 /PRNewswire/ -- Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, today announced the addition of two renal research and clinical experts, Ben Humphreys, M.D., Ph.D. and Giuseppe Remuzzi, M.D., F.R.C.P., from the Harvard Stem Cell Institute and Mario Negri Institute respectively, to its panel of Research & Development Advisors. This panel provides counsel to Tengion and engages leading researchers, clinicians, and patient advocates with the company as it advances its Organ Regeneration Platform™. The newest additions to the panel will work with Tengion in the area of renal function and chronic kidney disease (CKD) as the Company continues to advance its Neo-Kidney Augment™ program. The Neo-Kidney Augment, which is designed to delay or prevent the need for dialysis or kidney transplantation in patients at risk of chronic kidney failure, has demonstrated consistently positive data that Tengion scientists have published or presented in four different animal models of kidney failure, including in large animals.
"The appointment of these leaders to our advisory panel will provide Tengion with rich insights as we work to advance our Neo-Kidney Augment to clinical trials," said Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion. "There is a great need for new treatments for patients with chronic kidney disease," stated Dr. Remuzzi. "I look forward to helping Tengion identify the most rapid and efficient pathways to clinical trials." Dr. Humphreys added, "The recent preclinical findings for Tengion's Neo-Kidney Augment show that innovative approaches are beginning to offer promising results. I am enthusiastic about working with Tengion to explore these findings and further advance development."
Joining Tengion's panel of Research & Development Advisors are:
Giuseppe Remuzzi, M.D., F.R.C.P.
Dr. Remuzzi is the Head of Nephrology and Dialysis and Chairman of the Department of Transplantation at Bergamo Hospital and head of the Negri Bergamo Laboratories, which is devoted to the study of renal disease and a center that he has directed since 1984. As a recognized leader in the field of kidney regeneration, Dr. Remuzzi recently authored a review article in the prestigious medical journal, The Lancet, on the field of kidney regeneration. As director of the Negri Bergamo Laboratories and the affiliated Clinical Research Center for Rare Diseases, both divisions of the Mario Negri Institute for Pharmacological Research, Dr. Remuzzi leads a diverse team of researchers studying human renal diseases and their corresponding experimental models from the perspective of pathophysiology and therapeutic intervention. Dr. Remuzzi's work and research has helped drive major advances in many areas of nephrology, including transplant immunology and tolerance. Dr. Remuzzi completed his medical training at the University of Pavia and received specialty training in Hematology and Nephrology at the University of Milan. He has been awarded honorary memberships of the Association of American Physicians and the British Royal College of Physicians and has authored and co-authored more than 1,000 scientific articles, reviews and monographs.
Ben Humphreys, M.D., Ph.D.
Dr. Humphreys is an Assistant Professor of Medicine at Harvard Medical School and Principal Faculty Member of the Harvard Stem Cell Institute and Co-Director of the Harvard Stem Cell Institute Kidney Program. He received a bachelor's degree from Harvard College and M.D. and Ph.D. degrees from Case Western Reserve University. Dr. Humphreys completed a residency in Internal Medicine at Massachusetts General Hospital and a fellowship in Nephrology at Brigham and Women's Hospital in Boston. He is the recipient of a Harvard Stem Cell Institute Seed Grant, the National Kidney Foundation Young Investigator Award and the American Society of Nephrology Gottschalk Research Scholar Award. He investigates kidney repair in order to translate this knowledge into therapies for patients with kidney disease.
The Neo-Kidney Augment is Tengion's lead preclinical program and is intended to prevent or delay the need for dialysis or kidney transplant by increasing functional kidney mass in patients with advanced chronic kidney disease, a significant unmet medical need. Tengion has now published or presented consistently positive data on the effect of its approach on kidney function in four different animal models of chronic kidney disease, including in a canine model of kidney failure. By the end of 2011, Tengion intends to seek an initial regulatory interaction with FDA for the Neo-Kidney Augment program to clarify the path to clinical trials.
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. An initial clinical trial is ongoing for the Company's 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. The Company's lead preclinical program is the Neo-Kidney Augment™, which is designed to delay or prevent the need for dialysis or transplantation in patients at risk for kidney failure. Tengion has also applied its technology in two Phase II clinical trials for Tengion's Neo-Bladder Augment™ for the treatment of neurogenic bladder. Tengion has worldwide rights to its product candidates. For more information, please visit www.tengion.com.
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 successfully enroll patients in its clinical trials, including its initial clinical trial for the Neo-Urinary Conduit; (ii) 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; (iii) the results of the clinical trial for the Neo-Urinary Conduit will support further development of that product candidate; (iv) data from the Company's ongoing preclinical studies will continue to be supportive of advancing its preclinical product candidates; (v) the Company will be able to progress its product candidates that are undergoing preclinical testing, including the Neo-Kidney Augment, into clinical trials; and (vi) the Company will be able to obtain the capital it needs to continue to develop its product candidates. 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.