WINSTON-SALEM, N.C., April 1, 2013 /PRNewswire/ — Tengion, Inc. (TNGN), a leader in regenerative medicine, today announced the acceptance of the Company’s Clinical Trial Application (CTA) filed with the Medical Products Agency (MPA) in Sweden to initiate a Phase 1 clinical trial to evaluate the safety and delivery of its Neo-Kidney Augment™ product in up to five patients with advanced chronic kidney disease (CKD).
“We are excited to have received MPA approval for the Neo-Kidney Augment Phase 1 trial in Sweden and expect to initiate the trial this quarter. We will use the data from this trial to establish safety and a delivery approach for our planned U.S. Phase 1 trial, which we expect to start in the fourth quarter of 2013. We are confident that the Neo-Kidney Augment can truly benefit CKD patients in need of transformative, life-changing technologies,” said John L. Miclot, President and Chief Executive Officer of Tengion.
Tengion’s 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 CKD patients. The Phase 1 trial will involve delivery of an active regenerative dose of Neo-Kidney Augment in patients with CKD. The trial is expected to enroll up to 5 patients in 2013 and will follow each patient for up to 2 years.
This CTA acceptance follows Tengion’s inspection by an Official Qualified Person for regulatory compliance with European Medicines Agency standards for clinical manufacturing, processes, management, and quality programs. Following the successful inspection, the Company was issued a Declaration of Compliance to enable clinical production of the Neo-Kidney Augment at its cGMP manufacturing facility located in Winston-Salem, North Carolina.
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’s Clinical Trial Application for the Neo-Kidney Augment has been approved by the Medical Products Agency and initiation of the clinical trial in Sweden is expected in the second quarter of 2013. Additionally, the Company plans to file an IND to the U.S. FDA during the second quarter of 2013, with a U.S. trial initiation planned for the fourth 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 plans to initiate a Phase 1 clinical trial in Sweden during the second quarter of 2013 for 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-Urinary Conduit and the Neo-Kidney Augment; 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 U.S. Food and Drug Administration could place the Neo-Urinary Conduit clinical trial on clinical hold; (ii) the Medical Products Agency could place the Neo-Kidney Augment clinical trial on clinical hold; (iii) patients enrolled in the Neo-Urinary Conduit or Neo-Kidney Augment clinical trials may experience adverse events, which could delay one of the clinical trials or cause the Company to terminate the development of one of its product candidates; (iv) the Company may have difficulty enrolling patients in its clinical trials; (v) data from the Company’s ongoing preclinical studies, including the GLP program for the Neo-Kidney Augment, may not continue to be supportive of advancing such preclinical product candidates; and (vi) the Company may be unable to progress its product candidates that are undergoing preclinical testing 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.