Tengion Provides Business Update and Reports Fourth Quarter and Full Year 2012 Financial Results
-- Actively Recruiting for Neo-Urinary Conduit™ Phase 1 Trial --
-- Neo-Kidney Augment™ on Track to Begin Clinical Trials in Sweden and U.S. in 2013 --
WINSTON-SALEM, NC, March 18, 2013 -- Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today reported its financial results for the fourth quarter and full year ended December 31, 2012 and provided a business update.
“Over the last year we made continued progress in our Phase 1 trial for the Neo-Urinary Conduit. We have initially demonstrated that urinary tissue can be regenerated in a limited number of patients. These findings in the clinical trial are consistent with our animal studies in which we demonstrated the ability of our technology to consistently regenerate an organ composed of urinary tissue. We have also defined a surgical procedure that has been transferred to additional clinical sites. We look forward to successfully implanting the remaining three patients in the trial and then working with the FDA this year to plan for a potential Phase 2/3 clinical trial,” said John L. Miclot, President and Chief Executive Officer of Tengion. “In addition in late 2012, we successfully refinanced the Company in order to complete enrollment in the Phase 1 Neo-Urinary Conduit trial and to submit an IND filing to the FDA for our Neo-Kidney Augment program in 2013.”
Neo-Urinary Conduit Clinical Program Update
In January 2013, Tengion announced that it 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 reducing the typical incidence of post-operative co-morbidities associated with the current standard of care.
The enrollment of the seventh patient in the Phase 1 trial allowed the Company to train additional physicians and open three further sites. All five sites are now actively recruiting for the Phase 1 trial. Based on information from this trial, Tengion plans to work with the U.S. Food and Drug Administration (FDA) during 2013 to plan for a potential Phase 2/3 clinical trial of this product candidate.
The following information was filed by Tengion Inc (TNGNQ) on Monday, March 18, 2013 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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Ticker: TNGNQ CIK: 1296391 Form Type:10-K Annual Report Accession Number: 0000950159-13-000211 Submitted to the SEC: Thu Mar 28 2013 5:20:22 PM EST Accepted by the SEC: Thu Mar 28 2013 Period: Monday, December 31, 2012 Industry: Biological Products No Disgnostic Substances