EAST NORRITON, Pa., Sept. 13, 2011 /PRNewswire/ -- Tengion, Inc. (Nasdaq: TNGN) today announced that it has reinitiated enrollment of patients in the ongoing initial clinical trial of its lead product candidate, the Neo-Urinary Conduit™, which is being evaluated in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy).
"We are pleased to resume screening procedures to enroll the next patient in our ongoing trial," said Sunita Sheth, M.D., Chief Medical Officer and Vice President Clinical and Regulatory Affairs of Tengion. "We anticipate enrolling our fourth patient during the fourth quarter of this year, followed by another patient during the first quarter of 2012. After enrolling the fifth patient and safety data permitting, we intend to discuss with clinical investigators and the Data Safety Monitoring Board a reduction in the amount of time between future patient implants."
Brian Davis, Chief Financial Officer and Vice President, Finance of Tengion, will present this update at the Rodman & Renshaw 13th Annual Healthcare Conference later today at 1:35 pm EDT. Mr. Davis' presentation can be viewed at http://www.wsw.com/webcast/rrshq20/tngn and a live webcast of his presentation can be accessed later today under "Calendar of Events" in the Investors section of the Company's website at www.tengion.com.
This ongoing trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit, as well as to allow the clinical investigators to optimize the surgical procedure and post-surgical care by incorporating the outcomes observed in each patient into the surgical approach for subsequent patients, as necessary. The trial is being conducted at the University of Chicago Medical Center and at The Johns Hopkins Hospital in Baltimore, Maryland. To date, three patients have been enrolled and implanted in the clinical trial. Data from these patients have allowed clinical investigators to make surgical modifications for the trial moving forward in an effort to address conduit patency and vascular supply. Tengion recently submitted these surgical modifications and additional clinical data from the trial to the U.S. Food and Drug Administration (FDA), enabling the resumption of enrollment of additional patients.
About the Neo-Urinary Conduit
The Neo-Urinary Conduit is a combination of a patient's own cells and bioabsorbable scaffold that is intended to catalyze regeneration of a native bladder tissue conduit, passively transporting urine from the ureters through a stoma, or hole in the abdomen, into a standard ostomy bag. Patients requiring some form of urinary diversion with today's standard of care, the use of a segment of bowel tissue to construct a conduit for urine to exit from the body into an ostomy bag, are at risk of complications associated with the use of bowel tissue as well as those associated with the surgery to harvest the bowel tissue.
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 the Neo-Urinary Conduit; and (ii) expectations regarding the initial clinical trial of the Neo-Urinary Conduit 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; and (v) 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.