Highlights Include Additional Cell Characterization Supporting the Neo-Urinary Conduit™ and New Biomaterial Testing for the Neo-Kidney Augment™ Program
EAST NORRITON, Pa., Dec. 13, 2011 /PRNewswire/ -- Tengion, Inc. (NASDAQ: TNGN), a leader in regenerative medicine, today announced that new data from the Company's Neo-Urinary Conduit™ (NUC) and Neo-Kidney Augment™ (NUC) programs are featured in several presentations at the TERMIS North America Annual Conference being held December 11-14, in Houston, TX.
The NUC program is further supported by various cellular and molecular studies demonstrating the genetic stability of the autologous smooth muscle cells used in the Neo-Urinary Conduit. Supporting the utility of the technology platform are additional experiments showing the suitability of using adipose-derived smooth muscle cells from bladder cancer patients who have undergone prior cancer treatment. In support of advancing the NKA program toward clinical studies, Tengion has previous demonstrated increased survival in an obese, diabetic rat model of chronic kidney disease. A new analysis using multiple species, including canines, demonstrated that NKA had broad regenerative outcomes in multiple kidney tissue compartments. Renal filtration, tubular and urine concentrating effects were all shown to be improved and constitute significant predictors for survival. To support clinical translation, prototype formulations which combined selected regenerative renal cells with various gelatin-based hydrogels were well-tolerated and elicited neo-kidney tissue regeneration.
"These presentations highlight the work of Tengion scientists to translate regenerative medicine science into product candidates for patients," said Tim Bertram, DVM, Ph.D., President, Research and Development and Chief Scientific Officer of Tengion. "In our two lead programs, we continue to build the evidence for the specific cells and biomaterials used in our product candidates and their potential to address important medical needs in patients with bladder cancer and chronic kidney disease, respectively."
The presentations, posters, and abstracts are available on Tengion's website at http://www.tengion.com/news/documents.cfm:
- Genetic Stability of Autologous Human Smooth Muscle Cells (http://www.tengion.com/news/documents/Justewicz-SMC-Stability-Tengion-TERMIS-NA-Houston-14Dec11.pdf)
- Characterization of Chemotherapy and/or Radiation Treated Human Smooth Muscle Cells for Use in Regenerative Medicine (http://www.tengion.com/news/documents/Justewicz-Cancer-Secretome-Tengion-TERMIS-NA-13Dec11.pdf)
Neo-Kidney Augment :
- Selected Regenerative Renal Cells combined with Bioresorbable Natural Biomaterials Catalyze in vivo Kidney Tissue Regeneration (http://www.tengion.com/news/documents/2011-Jain-TERMIS-NA-Presentation.pdf)
- Multivariate Analysis of Preclinical Data from the Tengion Neo-Kidney Augment (http://www.tengion.com/news/documents/Spencer-TERMIS-Presentation_121411_rev2.pdf)
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 candidate 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.
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 Phase I 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; and (v) the Company will be able to progress its product candidates that are undergoing preclinical testing, including the Neo-Kidney Augment, into clinical trial and (vi) the Company will be able enter into strategic partnerships on favorable terms, if at all, or obtain the capital it needs to develop its product candidates and continue its operations. 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.