WINSTON-SALEM, N.C., Aug. 14, 2012 /PRNewswire/ --Tengion, Inc. (TNGN), a leader in regenerative medicine, today reported its financial results for the second quarter ended June 30, 2012 and provided a business update.

"In mid-June we announced significant progress toward delivering on critical value creating milestones for our most advanced product candidate, the Neo-Urinary Conduit, and we are pleased to announce continued advances," said John L. Miclot, President and Chief Executive Officer of Tengion. "The fifth patient is implanted in the Phase 1 clinical trial and we are actively recruiting to enroll the next two patients concurrently. We have also completed our plans to train surgeons on the surgical procedure at four additional clinical sites, allowing the subsequent three patients in this trial to be enrolled in any of the six centers. For our lead preclinical candidate, the Neo-Kidney Augment, with our GLP animal studies currently underway, we are on track to submit an IND filing for this product candidate during the first half of 2013. We are diligently focused on executing on these clinical goals and look forward to updating you on our progress."

Neo-Urinary Conduit Clinical Program UpdateTengion has implanted five patients 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 translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients while assessing the safety and preliminary efficacy of the Neo-Urinary Conduit. The trial is an open-label, single-arm study, which is currently expected to enroll up to ten patients.

Following a positive meeting with the Data Safety Monitoring Board (DSMB), the Company is now actively recruiting in order to proceed with concurrent enrollment of patients six and seven as soon as possible. Assuming appropriate safety data, the Company anticipates commencement of efforts to enroll an additional three patients approximately six weeks after implant of patients six and seven, thereby allowing the Company to achieve its stated objective of completing implantation of up to 10 patients by the end of 2012.

The trial is currently being conducted at the University of Chicago Medical Center and at The Johns Hopkins Hospital in Baltimore, Maryland. In addition to the two original trial sites, the trial has been expanded to include four additional centers for patients seven through ten. The additional trial sites are Memorial Sloan-Kettering Cancer Center in New York, NY; Baylor College of Medicine, Houston, Texas; University of Michigan Comprehensive Cancer Center in Ann Arbor, MI; and a fourth site in Boston, MA.

Neo-Kidney Augment Preclinical Program UpdateTengion's lead preclinical program, the 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 patients with advanced chronic kidney disease (CKD). 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.

Tengion has commenced the good laboratory practice (GLP) animal study program required by the U.S. Food and Drug Administration (FDA) to support an Investigational New Drug (IND) filing and initiation of a Phase 1 clinical trial in CKD patients. These GLP studies are consistent with the preclinical animal models already conducted by Tengion, which yielded positive data demonstrating slowing of kidney disease progression and improved survival.

Tengion anticipates that it will submit an IND filing for the Neo-Kidney Augment during the first half of 2013 and that its Phase 1 trial will provide initial human proof-of-concept data in 2014. Tengion is also exploring an entry strategy in Europe for its Neo-Kidney Augment product candidate using the Advanced Therapy Medicinal Products (ATMP) pathway, an established regulatory route in Europe for advanced cell-based therapies. Tengion plans to define the European regulatory pathway for Neo-Kidney Augment program in the second half of 2012.

Financial UpdateFor the six months ended June 30, 2012, the Company reported an adjusted net loss of $8.9 million, or $3.74 per basic and diluted common share, compared to an adjusted net loss of $13.1 million, or $6.79 per basic and diluted common share, for the same period in 2011. The decreased adjusted net loss for the 2012 period was primarily due to a reduction in compensation and related expenses of $2.5 million and a decrease in depreciation expense of $1.8 million.

The decreased compensation-related expenses during the 2012 period, of which $1.2 million were attributable to research and development personnel and $1.3 million were attributable to general and administrative personnel, were primarily due to lower headcount resulting from the Company's November 2011 restructuring. The decreased depreciation expense during the 2012 period resulted from both a change during the second quarter of 2011 in the estimated useful life of leasehold improvements at the Company's leased facility in Winston-Salem, North Carolina and an impairment during the fourth quarter of 2011 of the carrying value of the Company's leased facility in East Norriton, Pennsylvania.

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Tengion Reports Second Quarter 2012 Financial Results

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