Tengion Presents New Large Animal Data Demonstrating Functional Kidney Regeneration at the American Society for Transplantation Annual Conference
Neo-Kidney Augment Approach Shows Promising Early Effect on Kidney Function, Consistent with Early Effects Seen in Long-Term Studies with Small Animals
EAST NORRITON, Pa., Oct. 25 /PRNewswire-FirstCall/ -- Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, presented new data on Saturday, October 23, 2010 in a podium presentation at the American Society for Transplantation's Annual Scientific Exchange in Orlando, FL. The presentation highlighted new early data from Tengion's Neo-Kidney Augment™ development program demonstrating promising improvements in kidney function with an autologous cellular therapy approach to kidney regeneration in a canine model of chronic kidney disease. Specifically, the presented data showed improvements in kidney filtration, protein balance, and weight gain in treated animals compared to a control group. Effects in a pilot study have persisted through the first three months after treatment. A follow-up study has demonstrated efficacy as early as seven weeks after implantation. The studies are designed to monitor progression over a six-month period and both studies are ongoing.
"These early data in a large mammal model are very encouraging and consistent with the early effects that we have seen in other small animal studies where six-month and one-year durable improvements in kidney function have been recently published and reported by our scientists," stated Sharon Presnell, Ph.D., senior vice president of regenerative medicine at Tengion. "These studies are active, but the interim results continue to underscore our confidence in the Neo-Kidney Augment program as this is the fourth preclinical model in which we have been able to demonstrate positive effect."
Tengion's Neo-Kidney Augment product candidate is designed to prevent or delay the need for dialysis or kidney transplant by enhancing functional kidney mass in patients with progressive chronic kidney disease. The Company is developing a product candidate that uses the patient's own kidney cells, procured by a routine biopsy, and is then implanted into the failing kidney, catalyzing the regeneration of functional kidney tissue.
Tengion's presentation at AST is available at http://www.tengion.com/news/documents.cfm.
A recently published paper showcasing additional preclinical results from this development program is now 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. In September 2010, Tengion announced the publication of this study in which rodents with chronic kidney disease 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.
Further details on the Neo-Kidney Augment development program and on the Company's product development portfolio and upcoming milestones will be presented at its Analyst and Investor Meeting on Wednesday, October 27, 2010 from 1:00 to 3:00 pm ET. The live webcast of the event will be available under the Investors section of the Company's website at www.tengion.com. To participate in the webcast, please pre-register at http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=218965&eventID=3420638. An archive of the event will be available on the Company's website.
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.
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 the Company's ongoing preclinical studies will continue to be supportive of advancing its 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.
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Posted: October 2010