Tengion Announces New Kidney Data at TERMIS
Highlights Include Additional Efficacy Data in Large Animals with Chronic Kidney Disease and New Mechanism of Action Data Presented for the Neo-Kidney Augment™ Program
EAST NORRITON, Pa., December 7, 2010 --Tengion, Inc. (NASDAQ: TNGN), a leader in regenerative medicine, today announced that data from the Company’s Neo-Kidney Augment™, Neo-GI Augment™, and Neo-Urinary Conduit™ programs are being featured in several posters and oral presentations at the TERMIS North America annual meeting being held December 5-8, in Orlando, Florida. Key data featured include the first presentations on the Neo-Kidney Augment mechanism of action, product formulation, and additional efficacy data from an ongoing study in a large animal model demonstrating the ability of the Neo-Kidney Augment program to improve kidney function in animals at risk of kidney failure. Additional new data are being presented demonstrating that the technology used with the Neo-Urinary Conduit can be successfully applied to stimulate regeneration of gastrointestinal tissue based on proof-of-concept studies for the Neo-GI Augment program.
“In the Neo-Kidney Augment program, we continue to see consistency of results in four preclinical models tested, all showing beneficial effects towards the prevention of kidney failure,” said Tim Bertram, DVM, Ph.D., Executive Vice President and Chief Scientific Officer of Tengion. “Importantly, new data on the mechanism of action suggest that our approach has meaningful local effects on both fibrotic and inflammatory response pathways in the regenerating kidney. In addition, our data now demonstrate the potential to extend the Neo-Urinary Conduit tubular technology platform to esophageal and intestinal tissues.”
The presentations, posters, and abstracts are available on Tengion’s website:
- Bioactive Renal Cells Augment Renal Function in the ZSF1 model of Diabetic Nephropathy
- Paracrine Factors Derived from Bioactive Kidney Cells Provide Anti-fibrotic Signals in vitro and may Mediate Regenerative Outcomes in vivo
- Secreted Factors from Bioactive Kidney Cells Attenuate NF-kappa-B Signaling Pathways: Implications for a Paracrine Mechanism of Immune Regulation and Regenerative Outcomes
- In vivo Evaluation of Biomaterials in Mammalian Kidney
- Mammalian Kidney Nephrogenic Response to Primary Renal Cell/Biomaterial-based Neo-Kidney Augment™ Prototype
Neo-GI Augment http://www.tengion.com/news/documents.cfm#5
- Esophageal Tissue Engineering using an Organ Regeneration Technology Platform
- Tissue Engineering of Small Intestines using a Neo-Urinary Organ Regeneration Technology
- Characterization of Autologous Smooth Muscle Cells Following Treatment with Bladder Cancer Drugs
- Development of a Bioreactor System for Preparation of Tubular Organs
- A Regenerative Urinary Diversion Tissue-Engineered from Autologous Smooth Muscle Cells and a Biodegradable Scaffold
- Regeneration of Native-Like Mucocutaneous Region at the Skin-Conduit Junction Following Neo-Urinary Conduit™ Implantation
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 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.
Posted: December 2010