Tengion Issued Notice of Allowance for U.S. Patent Application Covering Renal Regeneration for its Neo-Kidney Augment™ Product Candidate
WINSTON-SALEM, N.C., Nov. 5, 2012 /PRNewswire/ -- Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 12/617,721, titled "Isolated Renal Cells and Uses Thereof." The application includes claims intended to protect important aspects of Tengion's renal regenerative product candidate, the Neo-Kidney Augment™, for the treatment of advanced chronic kidney disease (CKD).
"This Notice of Allowance is based on the novel ability of our regenerative renal cells to regenerate functional kidney tissue in chronically diseased kidneys," said John Miclot, Tengion's President and Chief Executive Officer. "Tengion's goal is to protect the commercial potential of the Neo-Kidney Augment beyond 2030 through patent protection, know-how, regulatory exclusivity and trade secrets and by taking advantage of manufacturing barriers to entry. The issuance of this Notice of Allowance, along with other recent patent prosecution progress with the USPTO and in other parts of the world, confirms the breadth and strength of our intellectual property for the Neo-Kidney Augment and underlying technologies."
Once issued, this patent will provide Tengion broad protection for not only a selected population of regenerative renal cells capable of regenerating functional kidney tissue mass in chronically diseased kidneys but also various formulations of this selected cell population allowing for the optimization of product formulations and delivery in the clinical setting.
"A strategic theme for Tengion's R&D effort is to acquire and develop intellectual property for safe and effective cell-based therapies, and this latest Notice of Allowance represents an important component of our expanding IP portfolio," Mr. Miclot continued. "We believe that these therapies have the potential to address significant unmet medical needs facing the healthcare system."
Information on Tengion's patents and pending applications in the United States can be found on the Patent Application Information Retrieval, or PAIR, system maintained by the USPTO at http://portal.uspto.gov/external/portal/pair.
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 anticipates submitting an IND filing for the Neo-Kidney Augment to FDA during the first half of 2013. Tengion is also exploring moving forward using the Advanced Therapy Medicinal Products (ATMP) pathway, an established regulatory route in Europe for advanced cell-based therapies.
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.