EAST NORRITON, Pa., Nov. 16, 2010 /PRNewswire-FirstCall/ -- Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, announced today that the scheduled one-month, post-operative clinical assessment of the first implanted bladder cancer patient in its ongoing clinical trial has been completed as expected and has permitted the second patient to be enrolled without delay. The protocol for this initial clinical trial calls for each of the first few patient implantations to occur at least eight weeks after the previous patient surgery. The surgical procedure may be modified in subsequent patients based on the experience gained by the prior patient(s) enrolled. No modifications to the protocol have been made based on the experience with the first patient.
"We are very encouraged by the response we have seen so far in our first patient and we look forward to continuing to advance this trial and to enrolling additional patients," commented Sunita Sheth, M.D., Vice President and Chief Medical Officer at Tengion.
This trial is evaluating Tengion's Neo-Urinary Conduit in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The ongoing study is designed to provide data on the safety profile for the Neo-Urinary Conduit as well as to optimize the surgical technique and the ideal post-surgical patient care before proceeding into larger trials. The first two patients are being treated at the University of Chicago Medical Center by the principal investigator at the site for this study, Gary D. Steinberg, M.D., Professor of Surgery and Director, Urologic Oncology. The trial is also being conducted at a second clinical site at The Johns Hopkins Hospital in Baltimore, Maryland.
Tengion expects to implant five patients by the middle of 2011 with scheduled three-month clinical assessments on all patients expected to be completed in the second half of 2011. The Company anticipates providing an enrollment update on this trial with its next quarterly financial report.
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. 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.
|SOURCE Tengion, Inc.|
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