Tengion Inc. Announces Clinical Progress for Neo-Urinary Conduit™ Phase 1 Trial and Regulatory Advance for Neo-Kidney Augment™
Published: Jan 31, 2013
WINSTON-SALEM, N.C., Jan. 30, 2013 /PRNewswire/ -- Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today announced advances for its two lead programs, the Neo-Urinary Conduit and Neo-Kidney Augment.
"We look forward to successfully implanting the remaining three patients in the ongoing Phase 1 trial for the Neo-Urinary Conduit by the end of this quarter. Following the implantation of patient seven, we have begun to transfer the surgical procedure to additional centers with newly trained investigators, which we believe will accelerate enrollment in the next several weeks," said John L. Miclot, Tengion's President and Chief Executive Officer. "We are working diligently to progress our Neo-Kidney Augment program into the clinic in Sweden in the second quarter of 2013.We also plan to submit an IND filing to the U.S. FDA for the Neo-Kidney Augment program during the same quarter. We are confident that both our lead products have very strong potential to be the new standards of care and we are eager to execute on our anticipated milestones in the coming months."
Neo-Urinary Conduit Phase 1 Clinical Trial Update
Tengion announced today that it has successfully implanted the seventh patient 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). 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. The Neo-Urinary Conduit offers patients potential improvements over the standard of care, including a shorter and less complex surgical procedure, improved recovery times and faster hospital discharges, as well as no evidence of the typical post-operative co-morbidities associated with the current standard of care.
Tengion is proceeding with concurrent enrollment of the remaining three patients in the Phase 1 trial. There are now six centers open for recruiting patients for this clinical trial and Tengion anticipates that it will implant 10 patients by the end of the first quarter of 2013, which would complete enrollment in the trial.
Neo-Kidney Augment Clinical Development Update
Tengion also announced today that it has filed a Clinical Trial Application (CTA) with the Medical Products Agency (MPA) in Sweden to initiate a Phase 1 clinical trial to evaluate safety and delivery of its Neo-Kidney Augment product in up to five patients with chronic kidney disease (CKD). The Neo-Kidney Augment is intended to prevent or delay the need for dialysis or kidney transplant by catalyzing the regeneration of functional kidney tissue in patients with advanced CKD. Following MPA approval of the CTA, Tengion expects to initiate a Phase 1 trial in Sweden in the second quarter of 2013.
Tengion also expects to submit an Investigational New Drug (IND) filing for the Neo-Kidney Augment to the U.S. Food and Drug Administration (FDA) during the second quarter of 2013. Following FDA approval of the IND, Tengion expects to initiate a Phase 1 clinical trial in the U.S. in the fourth quarter of 2013 and anticipates that this trial will provide initial human proof-of-concept data in 2014.
Tengion is currently conducting the good laboratory practice (GLP) animal study program required by the FDA to support the IND filing and initiation of a Phase 1 clinical trial in CKD patients. These GLP studies are consistent with the preclinical animal models already conducted by Tengion, which yielded positive data demonstrating slowing of kidney disease progression and improved survival.
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. Seven patients have been implanted with the Neo-Urinary Conduit to date and the Company is focused on completing implantation of the remaining three patients in the trial by the end of the first quarter of 2013.
About the Neo-Kidney Augment
The Neo-Kidney Augment is intended to prevent or delay the need for dialysis or kidney transplantation by catalyzing the regeneration of functional kidney tissue in patients with advanced chronic kidney disease (CKD). This increase in functional kidney mass could thereby delay or prevent the need for dialysis or kidney transplant in patients with end stage renal disease (ESRD). According to the United States Renal Data System, more than $27 billion in Medicare costs each year are attributable to patients with ESRD and ESRD is associated with an approximate 20% mortality rate per year, with the average life expectancy of a patient initiating dialysis of approximately four years. Tengion scientists have published and presented positive data on the effect of the Company's Neo-Kidney Augment in four different preclinical models of CKD. Two of these preclinical models have been conducted for a sufficiently long period of time to demonstrate durability and an impact on survival. Tengion has filed a Clinical Trial Application (CTA) for the Neo-Kidney Augment with the Medical Products Agency (MPA) in Sweden and anticipates submitting an IND filing to the FDA during the second quarter of 2013.
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. Statements using words such as anticipate, expect, project, intend, plan, believe, words and terms of similar substance and any discussion of future plans, actions, or events generally identify forward-looking statements. Forward looking statements regarding the Company include but are 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, clinical trials and related filings or submissions with regulatory authorities. 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; (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.