Tengion, Inc., a leader in regenerative medicine, announced it has added The Johns Hopkins Hospital in Baltimore, Maryland as a second clinical trial site for its Phase I clinical trial of the Company's lead product candidate, the Tengion Neo-Urinary Conduit™, in bladder cancer patients requiring bladder removal.
"The addition of Johns Hopkins as the second clinical trial site is expected to expand enrollment efforts already underway at the University of Chicago site by expanding the pool of potential patients considered for entry in the trial," said Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion. "With its well-deserved international reputation for clinical excellence, we believe that Johns Hopkins and the Brady Urological Institute is an ideal site for our first clinical trial of this novel technology."
In addition to the participation of the primary investigator, Trinity Bivalacqua, M.D., Ph.D., the addition of Johns Hopkins as a study site allows for the participation of Mark Schoenberg, M.D., Bernard L. Schwartz Distinguished Professor of Urologic Oncology as a sub-investigator in the study. Dr. Schoenberg, a leader in urologic oncology, has consulted with Tengion on the development of the Neo-Urinary Conduit and the study's surgical protocol for the past 3 years. His consulting relationship with Tengion and participation as a sub-investigator are being managed by the Johns Hopkins University School of Medicine in accordance with its conflict of interest policies.
The initiation of the Phase I Neo-Urinary Conduit clinical trial at the University of Chicago was announced earlier this year. The study, which initially will enroll up to five patients with bladder cancer following bladder removal (cystectomy), is designed to establish the safety profile for the product as well as to optimize the surgical technique and the ideal post-surgical patient care that is intended to provide superior clinical outcomes. Utilizing the Company's proprietary organ regeneration technology, the Neo-Urinary Conduit is an implant designed to catalyze regeneration of native-like urinary tissue in patients who require a urinary diversion following cystectomy. The Neo-Urinary Conduit is produced using the patient's own smooth muscle cells from a routine fat biopsy and not cells from the diseased bladder, eliminating the risk of reintroducing cancerous cells from the bladder into the patient.
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, patients require some form of urinary diversion. Most patients 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. In its simplest form, the reconstruction involves creating a tubular structure out of bowel tissue and then connecting it to the ureters at one end and the skin at the other.
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-Urinary Conduit; and (ii) ongoing and planned preclinical studies and clinical trials. Although the Company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and the Company's business is subject to significant risk and uncertainties, and there can be no assurance that its actual results will not differ materially from its expectations. These risks and uncertainties include, among others: (i) the Company may have difficulty enrolling patients in its clinical trials, including the Phase I clinical trial for its Neo-Urinary Conduit; (ii) patients enrolled in the Company's clinical trials may experience adverse events related to its product candidates, which could delay the Company's clinical trials or cause the Company to terminate the development of a product candidate; and (iii) the Company may be unable to progress its product candidates that are undergoing preclinical testing into clinical trials. For further information with respect to factors that could cause the Company's actual results to differ materially from expectations, reference is made to the reports the company filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and the company disclaims any intention or responsibility for updating predictions or expectations contained in this release.
Source: Tengion, Inc