Tengion Working with Investigators to Optimize Surgical Approach for Ongoing Clinical Trial of Neo-Urinary Conduit in Patients with Bladder Cancer
EAST NORRITON, Pa., June 13, 2011 /PRNewswire/ -- Tengion, Inc. (Nasdaq: TNGN) today provided an update on the clinical trial of the Company's lead clinical product candidate, the Neo-Urinary Conduit™, for use in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). Tengion is continuing to work with investigators to optimize the surgical approach as part of its ongoing clinical trial of the Neo-Urinary Conduit in patients with bladder cancer and is working closely with clinical investigators, the Data Safety Monitoring Board (DSMB) and the U.S. Food and Drug Administration (FDA) to advance the study.
"As planned, we have reviewed clinical data from our ongoing trial with the investigators, the DSMB, and the FDA," said Sunita Sheth, M.D., Chief Medical Officer and Vice President Clinical and Regulatory Affairs of Tengion. "Based on these discussions, a plan has been developed to collect additional clinical data while modifying the surgical approach for future implants. We expect to submit these data and changes to the FDA in the third quarter, prior to enrolling additional patients in the trial."
The study is designed to provide data on the safety profile and preliminary efficacy for the Neo-Urinary Conduit as an alternative to the current standard treatment requiring the use of a patient's own bowel tissue, which can cause significant complications, as well as to provide investigators with data to optimize the surgical technique and post-surgical patient care during the trial. To date, three patients have been enrolled and implanted in the clinical trial at both the University of Chicago Medical Center and at The Johns Hopkins Hospital in Baltimore, Maryland.
About Bladder Cancer
The National Cancer Institute estimates that more than 70,000 new cases of bladder cancer are diagnosed each year and that there were nearly 15,000 deaths from bladder cancer in the United States last year. Bladder cancer is the costliest of all cancers from diagnosis to death. Because bladder cancer has a recurrence rate of 50-80 percent, patients requires life-long monitoring and treatment. Nearly $3 billion is spent in the U.S. alone each year on treatment of bladder cancer.
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-Urinary Conduit and the Neo-Kidney Augment; (ii) expectations regarding the initial clinical trial of the Neo-Urinary Conduit and (iii) expectations regarding planned preclinical studies of the Neo-Kidney Augment. 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's Neo-Urinary Conduit clinical trial will not be placed on clinical hold by the Food and Drug Administration, or FDA; (ii) patients enrolled in the Company's Neo-Urinary Conduit clinical trial will not experience additional adverse events, which could delay clinical trials or cause the Company to terminate the development of the Neo-Urinary Conduit; (iii) the Company will be able to successfully enroll patients in its clinical trials, including its initial clinical trial for the Neo-Urinary Conduit; (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 trial and (vii) the Company will be able to 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.