Patients in Tengion Inc.'s Clinical Trials Die From Unrelated Complications
Published: Oct 26, 2012
WINSTON-SALEM, N.C., Oct. 26, 2012 /PRNewswire/ -- Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today announced that two patients in the Phase 1 clinical trial of the Company's most advanced product candidate, the Neo-Urinary Conduit, have recently died due to afflictions unrelated to the Neo-Urinary Conduit or the surgical procedure. The fourth patient enrolled in the trial died of metastatic bladder cancer, which had not responded to combination chemotherapy and radiation. The sixth patient implanted with the Neo-Urinary Conduit passed away from a cardiopulmonary arrest following a myocardial infarction, or heart attack. This Phase 1 trial is ongoing and the trial sites are continuing enrollment initiatives.
"We are deeply saddened to hear of the passing of these two patients. We are grateful for their trial participation, which provided key insights into the safety and potential effectiveness of the Neo-Urinary Conduit, including its patency and functionality, a successfully redefined surgical procedure, a robust post-operative recovery, and the resilience of this product candidate to aggressive chemotherapeutic regimens," commented John L. Miclot, Tengion's President and Chief Executive Officer. "We are diligently working toward executing on our key clinical objectives for this program, namely to recruit the remaining four patients in this trial and complete implantation of up to 10 patients by the end of this year."
Neo-Urinary Conduit Phase 1 Clinical Trial Patient Update
Tengion announced today the unrelated deaths of two patients enrolled in the ongoing Phase 1 clinical trial of its most advanced product candidate, the Neo-Urinary Conduit, for use in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). Tengion successfully implanted the fifth patient in the ongoing Phase 1 trial in June 2012 and the patient's Neo-Urinary Conduit is currently functioning well with normal renal function.
The fourth patient enrolled in the Phase 1 trial was implanted with the Neo-Urinary Conduit in February 2012. The death of the fourth patient was associated with widespread metastasis of his bladder cancer. Until the time of his death, the patient's Neo-Urinary Conduit functioned well and he maintained normal renal function. The functionality of the Neo-Urinary Conduit facilitated a post-operative recovery that was strong enough to allow the patient to begin life-extending chemotherapy and radiation four weeks earlier than would have been possible with the current standard of care.
The sixth patient enrolled in the Phase 1 trial was implanted with the Neo-Urinary Conduit in August 2012 and was discharged from the hospital one week after implantation. At the time of his six week post-operative follow-up, the patient showed normal renal function, a patent stoma and a functioning Neo-Urinary Conduit. The death of the sixth patient enrolled in the Phase 1 trial was caused by a cardiopulmonary arrest following a myocardial infarction.
Tengion notified the Data Safety Monitoring Board of these events and the Phase 1 clinical trial is ongoing. Since these two reported deaths are unrelated to the Neo-Urinary Conduit or the surgical procedure, the Company continues to focus on enrolling the remaining four patients in the Phase 1 trial at its six clinical sites by the end of 2012.
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-like urinary tissue conduit, passively transporting urine from the ureters through a stoma, or hole in the abdomen, into a standard ostomy bag. Standard of care for patients requiring a non-continent urinary diversion uses bowel tissue to construct a conduit for urine to exit from the body. There are over 20,000 urinary diversions performed annually in the United States and Europe. These patients are at risk for complications associated with the use of bowel tissue, as well as for those associated with the surgery to harvest the bowel tissue. The Neo-Urinary Conduit is the only product candidate currently in development that aims to avoid the use of bowel tissue. The Neo-Urinary Conduit is being evaluated in an ongoing Phase 1 clinical trial in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients. Six patients have been implanted with the Neo-Urinary Conduit to date and the Company is focused on completing implantation of the remaining patients in the trial by the end of 2012.
Tengion, a clinical-stage regenerative medicine company, is focused on developing its Organ Regeneration Platform to harness the intrinsic regenerative pathways of the body to regenerate a range of native-like organs and tissues with the goal of delaying or eliminating the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications. An initial clinical trial is ongoing for the Company's most advanced product candidate, the Neo-Urinary Conduit, an autologous implant that is intended to catalyze regeneration of native-like urinary 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 prevent or delay dialysis kidney transplantation by increasing renal function in patients with advanced chronic kidney disease. 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: (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. Tengion's business is subject to significant risks and uncertainties and there can be no assurance that actual results will not differ materially from expectations. Factors which could cause actual results to differ materially from expectations include, among others: (i) the FDA could place the Neo-Urinary Conduit clinical trial on clinical hold; (ii) patients enrolled in the Neo-Urinary Conduit clinical trial may experience adverse events, which could delay the clinical trial or cause the Company to terminate the development of its Neo-Urinary Conduit; (iii) the Company may have difficulty enrolling patients in its clinical trials, including the Phase 1 clinical trial for the Neo-Urinary Conduit; (iv) data from the Company's ongoing preclinical studies, including the proposed GLP program for the Neo-Kidney Augment, may not continue to be supportive of advancing such preclinical product candidates; and (v) the Company may be unable to progress its product candidates that are undergoing preclinical testing, including the Neo-Kidney Augment, into clinical trials and the Company may not be successful in designing such clinical trials in a manner that supports development of such product candidates. 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.