Tengion Issued Additional Notice of Allowance for U.S. Patent Application Covering Cell-Scaffold Regeneration for its Neo-Urinary Conduit™ Product Candidate
WINSTON-SALEM, N.C., Nov. 8, 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. 12/612,606, titled "Cell-Scaffold Constructs." The application includes compositional claims on the construct and cellular elements of Tengion's most advanced product candidate, the Neo-Urinary Conduit™, as well as use claims covering this technology in additional clinical applications.
"This Notice of Allowance demonstrates the value of the proprietary technology behind our Neo-Urinary Conduit and further solidifies the strength and breadth of our intellectual property portfolio," said John Miclot, Tengion's President and Chief Executive Officer. "The issuance of this Notice of Allowance, together with the Notice we received for the Neo-Kidney Augment™ earlier this month, is evidence of Tengion's dedication to implementing an effective, long-term patent strategy."
Once issued, this patent will provide Tengion broad protection through 2030 for the regeneration, reconstruction, repair, augmentation or replacement of laminarly organized luminal organs or tissue structures using scaffolds and cells that are not derived from the diseased organs or tissues.
"This patent also represents a broad platform opportunity for multiple neo-organs and cell-based therapies of tubular and hollow organ regeneration," Mr. Miclot continued. "We believe this patented technology has therapeutic applications in several additional indications and this Notice of Allowance is another major step towards our goal to develop novel therapies for patients with limited treatment alternatives."
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-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.