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Tengion Announces Continued Clinical Progress in Its Two Lead Programs



Tengion Announces Continued Clinical Progress in Its Two Lead Programs

-- Expansion Planned for Neo-Kidney Augment™ Swedish Phase 1 Clinical Trial to
  Include Ten Additional Patients; U.S. Phase 1 Clinical Trial Initiated --

   -- Neo-Urinary Conduit™ U.S. Phase 1 Clinical Trial to Complete Patient
                                Enrollment --

WINSTON-SALEM, N.C., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Tengion, Inc.
(OTCQB:TNGN), a leader in regenerative medicine, today announced continued
clinical progress in its two lead programs, the Neo-Kidney Augment and the
Neo-Urinary Conduit.

The Neo-Kidney Augment, which is intended to prevent or delay dialysis and
transplantation by increasing renal function in patients with advanced chronic
kidney disease (CKD), was implanted in five CKD patients in 2013 in the
ongoing Phase 1 clinical trial in Sweden. The Neo-Kidney Augment is safe and
well tolerated in the five patients implanted to date. The Company now plans
to expand enrollment in this trial to 15 patients. The Company also announced
the initiation of a Phase 1 clinical trial in the U.S. under an open
Investigational New Drug (IND) application for the Neo-Kidney Augment. Tengion
will also complete patient enrollment in the ongoing U.S. Phase 1 clinical
trial for its second lead program, 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.

"Our lead clinical programs have continued to make progress, placing Tengion
at the forefront of regenerative medicine," commented John L. Miclot,
President and Chief Executive Officer of Tengion. "We believe that the
Neo-Kidney Augment product has the potential to provide tremendous advantages
for patients suffering from CKD and that there is great need for this
important product candidate. The planned enrollment expansion in Sweden and
the initiation of U.S. clinical development is very encouraging. We also
expect to move forward with the Neo-Urinary Conduit by engaging key opinion
leaders and the U.S. Food and Drug Administration (FDA) and for guidance on
next phase trials by mid-2014, and we believe the product has the potential to
be the new standard of care for bladder cancer patients following bladder
removal."

Neo-Kidney Augment Program Update

The Phase 1 trial of the Neo-Kidney Augment being conducted at the Karolinska
Institute in Stockholm, Sweden commenced in May 2013 and involves delivery of
an active regenerative dose of Neo-Kidney Augment in patients with CKD. The
Neo-Kidney Augment is safe and well tolerated in the five patients implanted
to date. As noted above, the Company plans to expand enrollment to 15
patients, and all patients in the trial will be followed for up to two years.

The recently initiated U.S. Phase 1 clinical trial will evaluate the safety
and delivery of the Company's Neo-Kidney Augment in patients with CKD. It is
expected to enroll up to 12 patients and will follow each patient for up to
two years. The Company anticipates that it will complete patient enrollment
during 2014.

Neo-Urinary Conduit Program Update

Tengion will complete patient enrollment in the ongoing Neo-Urinary Conduit
Phase 1 clinical trial and plans to engage key opinion leaders and the FDA for
guidance on potential next phase trials by mid-2014. The ongoing Phase 1 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.

About the Neo-Kidney Augment™

The Neo-Kidney Augment is an implant made from a patient's own cells and is
intended to catalyze the regeneration of functional kidney tissue in patients
with advanced chronic kidney disease (CKD). This increase in functional kidney
mass could thereby prevent or delay the need for dialysis and transplant in
patients with advanced chronic kidney disease (CKD). According to the United
States Renal Data System, there are approximately 26 million adults in the
U.S. who have CKD and 100,000 new patients who start on dialysis each year.
CKD affects more than 10% of the world's population. Additionally, $39 billion
in direct U.S. costs each year are attributable to patients with end-stage
renal disease, which is associated with an approximate 20% mortality rate per
year and an average life expectancy of a patient initiating dialysis of
approximately four years.  

About the Neo-Urinary Conduit™

Tengion's Neo-Urinary Conduit is designed to replace the standard of care for
bladder cancer patients undergoing cystectomy (removal of bladder). There are
over 25,000 cystectomies performed annually in bladder cancer patients in the
U.S. and Europe. The Neo-Urinary Conduit is an implant made from a patient's
own cells and is intended to catalyze regeneration of native-like urinary
tissue, thereby eliminating the need to use bowel tissue in the current
standard of care surgery. The Neo-Urinary Conduit is expected to eliminate the
short-term and long-term complications associated with use of bowel tissue,
such as electrolyte and metabolic disorders, nutritional and therapeutic-agent
absorption anomalies, kidney and urinary tract infections, and stone
formation. In addition, the Neo-Urinary Conduit is anticipated to improve
recovery times, which results in faster hospital discharges compared to the
current standard of care.

About Tengion

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. The Company is currently conducting Phase 1
clinical trials in Sweden and the U.S. for its Neo-Kidney Augment, which is
intended to prevent or delay dialysis and transplantation by increasing renal
function in patients with advanced chronic kidney disease.

A Phase 1 trial for the Company's 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, is ongoing.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth
in this press release, including statements regarding Tengion's plans,
potential opportunities, or other expectations, projections, goals,
objectives, strategies, timelines, clinical studies, product development and
the potential benefits of its products under development are forward-looking
statements within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. These forward-looking statements are
subject to risks and uncertainties that may cause actual results to differ
materially, including the risks and uncertainties associated with Tengion's
operating performance and financial position, research, development and
commercialization of products, the risks and uncertainties associated with
meeting the objectives of its clinical studies, including, but not limited to,
continued funding, delays or failures in enrollment, and the occurrence of
adverse safety events, obtaining regulatory approvals, and other risks
detailed from time to time in the Company's most recent Annual Report on Form
10-K and other documents subsequently filed with or furnished to the
Securities and Exchange Commission. These forward-looking statements are based
on current information that may change and you are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the
date of this press release. All forward-looking statements are qualified in
their entirety by this cautionary statement, and the Company undertakes no
obligation to revise or update any forward-looking statement to reflect events
or circumstances after the issuance of this press release.

CONTACT: Investor and Media Contact:
         Brian Davis
         brian.davis@tengion.com
         336.201.0155
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