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Tengion Provides Business Update and Reports First Quarter 2013 Financial Results
-- Phase 1 trial of Neo-Kidney Augment™ on track for initiation in Sweden in second quarter of 2013 and in U.S. in fourth quarter of 2013 --
-- Actively recruiting for final three patients in Neo-Urinary Conduit™ trial --
WINSTON-SALEM, NC, May 15, 2013 -- Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today provided a business update and reported its financial results for the first quarter ended March 31, 2013.
“We are very pleased to have achieved a significant milestone this quarter with the MPA approval for the Phase 1 trial in Sweden of the Neo-Kidney Augment. We expect to see further development of this program in the second quarter of this year with the initiation of the Phase I clinical trial in patients with Chronic Kidney Disease in Sweden and the IND filing for a Phase 1 trial in the U.S.," commented John L. Miclot, President and Chief Executive Officer of Tengion. "We also continue to actively recruit patients for the Phase I clinical trial for our Neo-Urinary Conduit and look forward to working with the FDA to plan for potential next stages. We see the advancement of our second program as indicative of the substantial value of our proprietary technology platform in regenerative medicine."
Neo-Urinary Conduit Clinical Program Update
Tengion's most advanced product candidate is the Neo-Urinary Conduit, for use in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). 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 announced in January 2013 that it had successfully implanted the seventh patient in the ongoing Phase 1 clinical trial of the Neo-Urinary Conduit. The enrollment of the seventh patient allowed Tengion to train additional physicians and open three further sites at Memorial Sloan Kettering, Baylor, and the University of Michigan, bringing the total number of active clinical trials centers to five. The trial is designed to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients, as well as to assess the safety and preliminary efficacy of the Neo-Urinary Conduit. Tengion continues to actively recruit three remaining patients in the Phase 1 trial.