Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human
Organ
Trial Aims to Study Safety and Efficacy of Tengion's Neo-Bladder
Construct in Spinal Cord Injury Patients
Contact: Gary Sender
Chief Financial Officer
Tengion Inc.
gary.sender@
East Norriton, PA (September 17, 2007) – Tengion, Inc., a leader in
regenerative medicine, announced today it has initiated a Phase 2
multi-center clinical trial of its neo-bladder construct, derived
from a patient's own cells. The U.S.-based study is being conducted
in 10 adult patients with neurogenic bladder due to spinal cord
injuries. Neurogenic bladder is a condition that can occur due to
spinal cord injury and may lead to kidney failure and incontinence,
even when patients receive optimal medical treatment.
This Phase 2 trial initiation follows the successful completion of
enrollment in the company's first (Phase 2) clinical trial of the
autologous neo-bladder construct in pediatric patients with
neurogenic bladder due to spina bifida. The commencement of
Tengion's spina bifida Phase 2 clinical trial was announced in the
first quarter of 2007.
"Tengion's novel regenerative medicine platform aims to address the
significant limitations of current treatment options for patients
with organ and tissue failure or loss," said Steven Nichtberger,
M.D., President and CEO of Tengion. "Our neo-bladder constructs,
which harness the body's natural ability to regenerate organs and
tissues using a patient's own cells, hold the promise to meet
critically important unmet medical needs. We look forward to
announcing results from both of these Phase 2 clinical studies."
Similar to the Phase 2 study in pediatric patients, the new Phase 2
study in adult patients with spinal cord injuries is evaluating the
safety and effectiveness of the neo-bladder construct at one year
after implantation. The neo-bladder construct design is based on
nearly two decades of research from Children's Hospital Boston (a
teaching affiliate of Harvard Medical School), MIT, The Wake Forest
Institute for Regenerative Medicine and Tengion. Previous academic
clinical research and results of use of the neo-bladder at
Children's Hospital Boston were described in an article published in
The Lancet on April 15, 2006.
The neo-bladder constructs for patients in both Phase 2 clinical
trials are being developed at Tengion's state-of-the-
manufacturing facility using cells taken from a small biopsy of each
patient's bladder. Each neo-bladder construct consists of a
biodegradable scaffold seeded with cells cultured by Tengion
scientists from the patient's own (i.e., autologous) healthy cells.
A surgeon implants the neo-bladder construct in the patient's body,
where it is designed to harness the body's inherent regenerative
capabilities resulting in a regenerated bladder with improved
functionality. The primary efficacy endpoint of the trial is
urodynamic function of the neo-bladder at one year post-
implantation. Data on the safety profile of the product will
continue to be collected after the one-year endpoint measurement
date. The trial is expected to complete enrollment over the next few
months.
About Tengion
Tengion Inc., a clinical stage biotechnology company, is a leader in
developing autologous neo-organs and tissues, such as bladders, that
are derived from the patient's own (autologous) cells. Tengion's
proprietary approach to regenerative medicine has the potential to
enable people with organ and tissue failure to lead healthier lives
without donor transplants or the side effects of current therapies.
Headquartered in East Norriton, PA, Tengion also has research and
pilot manufacturing facilities located in Winston-Salem, NC. For more
information, visit Tengion online at: http://www.tengion.
http://www.tengion.
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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