Tengion Announces First Implantation of Neo-Urinary Conduit(TM) in Initial Clinical Trial in Patients with Bladder Cancer
EAST NORRITON, Pa., Oct. 25 /PRNewswire-FirstCall/ — Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, announced today that surgeons at the University of Chicago have implanted its Neo-Urinary Conduit(TM) in the first patient as part of the ongoing clinical trial evaluating the Company’s lead product candidate in bladder cancer patients requiring a urinary diversion following bladder removal. The patient is being treated at the University of Chicago Medical Center by the study’s principal investigator, Gary D. Steinberg, M.D., professor of surgery and director, urologic oncology. The trial is also being conducted at The Johns Hopkins Hospital in Baltimore, Maryland.
“This implantation marks a significant milestone for bladder cancer patients and their physicians who are eager for a treatment alternative to the current standard of care,” said Steven Nichtberger, M.D., president and chief executive officer of Tengion.
For many bladder cancer patients who have their cancerous bladders removed, the current standard of care is the surgical creation of a urinary diversion using a segment of the patient’s own bowel tissue to carry urine from the kidneys to a plastic bag on the abdominal wall. Tengion’s Neo-Urinary Conduit is built from a patient’s own cells obtained from a fat biopsy. The product is designed to catalyze regeneration of native-like bladder tissue, eliminating the need to use bowel tissue as a replacement for the cancerous bladder. The Neo-Urinary Conduit is designed to avoid many of the complications associated with the use of bowel tissue. Complications most often associated with the current standard of care include bowel obstructions, bowel leakage, systemic absorption of urine via the bowel tissue, recurrent infections, stone formation, and mucus secretion in the urine.
The ongoing study, which initially will enroll up to five patients with bladder cancer following bladder removal, 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 surgical procedure may be modified in subsequent patients based on the experience gained by the prior patient(s) enrolled.
The primary safety and efficacy assessment of the Neo-Urinary Conduit will be made at 12 months post-implantation. During this first year, however, patients will be seen frequently by the study investigator and/or designated clinical team: every one to two weeks after hospital discharge through week eight, and then at month 3, 6, 9 and 12. Imaging will be performed at three-month intervals for the first year to examine the neo-organ’s structure, patency and identify any obstructions or other abnormalities. This frequent evaluation and the open-label nature of this study will provide significant ongoing feedback throughout the study.
Further details on the Neo-Urinary Conduit development program and on the Company’s product development portfolio and upcoming milestones will be presented at its Analyst and Investor Meeting on Wednesday, October 27, 2010 from 1:00 to 3:00 pm ET. The live webcast of the event will be available under the Investors section of the Company’s website at www.tengion.com. To participate in the webcast, please pre-register at http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=218965&eventID=3420638. An archive of the event will be available on the Company’s website.
About Bladder Cancer
According to the National Cancer Institute, bladder cancer is the sixth most common form of cancer in the United States with approximately 10,000 cases per year of bladder cancer requiring bladder removal. Following bladder removal, these patients require some form of urinary diversion and most are currently treated by using a segment of bowel tissue to construct a conduit for urine to exit from the body into an ostomy bag.
Tengion, a clinical-stage biotechnology company, has pioneered the Organ Regeneration Platform(TM) 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. Tengion commenced a Phase I clinical trial in the first half of 2010 for its 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. Tengion has also applied its technology in two Phase II clinical trials for Tengion’s Neo-Bladder Augment(TM) for the treatment of neurogenic bladder and is in preclinical development of its Neo-Kidney Augment(TM). 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 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.