EAST NORRITON, Pa., Jan. 10, 2011 /PRNewswire/ -- Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, today provided an update on the progress of its lead clinical and preclinical programs, including timing for 2011 milestones. The Company also announced that Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion will present at the J.P. Morgan Healthcare Conference on Thursday, January 13, 2011, at 1:00 p.m. PST.
The ongoing clinical trial of Tengion’s Neo-Urinary Conduit is evaluating the product in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The study is designed to provide data on the safety profile for the Neo-Urinary Conduit as well as to provide investigators with data to optimize the surgical technique and post-surgical patient care during the trial. The trial is proceeding, with the first patients providing investigators and the Company with important insights to optimize surgical techniques and post-surgical care. Including consideration of investigators’ potential modifications to the surgical technique, the Company expects that a total of five patients will have been implanted by the end of the third quarter of 2011 with scheduled three-month clinical assessments on all patients expected to be completed by the end of 2011. The Company also reported that it has expanded the inclusion criteria in the trial and that it has the option of expanding the trial to include up to ten patients, if desired, from up to six clinical sites. The Company continues to anticipate providing an enrollment update on this trial with its next quarterly financial report.
The Neo-Kidney Augment is the Company’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. During the second half of 2011, the Company intends to seek an initial regulatory interaction with FDA for the Neo-Kidney Augment program to clarify the path to clinical trials.
As noted above, Dr. Steven Nichtberger will present a corporate overview at the 29th Annual J.P. Morgan Healthcare Conference on Thursday, January 13, 2011, at 1:00 p.m. PST. A live audio webcast of the presentation can be accessed under “Calendar of Events” in the Investors section of the Company’s website at www.tengion.com or you may use the link: http://jpmorgan.metameetings.com/webcasts/healthcare11/directlink?ticker=TNGN An archived version of the webcast will be available on the Tengion website. The slide presentation is available today on Tengion’s website at http://phx.corporate-ir.net/phoenix.zhtml?c=218965&p=irol-presentations.
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. 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.
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 initial 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.
SOURCE Tengion, Inc.
