Tengion Announces Clinical Progress for Neo-Urinary Conduit™ Phase 1 Trial and
Regulatory Advance for Neo-Kidney Augment™
-- Seventh Patient Implanted in Neo-Urinary Conduit Phase 1 Clinical Trial; On
Track to Complete Enrollment by End of First Quarter 2013 --
-- Application to Conduct Neo-Kidney Augment Phase 1 Trial Filed with Swedish
Medical Products Agency --
WINSTON-SALEM, N.C., Jan. 30, 2013
WINSTON-SALEM, N.C., Jan. 30, 2013 /PRNewswire/ --Tengion, Inc. (OTCQB:
TNGN), a leader in regenerative medicine, today announced advances for its two
lead programs, the Neo-Urinary Conduit™ and Neo-Kidney Augment™.
"We look forward to successfully implanting the remaining three patients in
the ongoing Phase 1 trial for the Neo-Urinary Conduit by the end of this
quarter. Following the implantation of patient seven, we have begun to
transfer the surgical procedure to additional centers with newly trained
investigators, which we believe will accelerate enrollment in the next several
weeks," said John L. Miclot, Tengion's President and Chief Executive Officer.
"We are working diligently to progress our Neo-Kidney Augment program into the
clinic in Sweden in the second quarter of 2013.We also plan to submit an IND
filing to the U.S. FDA for the Neo-Kidney Augment program during the same
quarter. We are confident that both our lead products have very strong
potential to be the new standards of care and we are eager to execute on our
anticipated milestones in the coming months."
Neo-Urinary Conduit Phase 1 Clinical Trial Update
Tengion announced today that it has 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 no evidence
of the typical post-operative co-morbidities associated with the current
standard of care.
Tengion is proceeding with concurrent enrollment of the remaining three
patients in the Phase 1 trial. There are now six centers open for recruiting
patients for this clinical trial and Tengion anticipates that it will implant
10 patients by the end of the first quarter of 2013, which would complete
enrollment in the trial.
Neo-Kidney Augment Clinical Development Update
Tengion also announced today that it has filed a Clinical Trial Application
(CTA) with the Medical Products Agency (MPA) in Sweden to initiate a Phase 1
clinical trial to evaluate safety and delivery of its Neo-Kidney Augment
product in up to five patients with chronic kidney disease (CKD). 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 CKD. Following MPA approval of the CTA, Tengion
expects to initiate a Phase 1 trial in Sweden in the second quarter of 2013.
Tengion also expects to submit an Investigational New Drug (IND) filing for
the Neo-Kidney Augment to the U.S. Food and Drug Administration (FDA) during
the second quarter of 2013. Following FDA approval of the IND, Tengion expects
to initiate a Phase 1 clinical trial in the U.S. in the fourth quarter of 2013
and anticipates that this trial will provide initial human proof-of-concept
data in 2014.
Tengion is currently conducting the good laboratory practice (GLP) animal
study program required by the FDA to support the 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
About the Neo-Urinary Conduit™
The Neo-Urinary Conduit™ is a combination of a patient's own cells and
bioabsorbable scaffold that is intended to catalyze regeneration of a
native-like urinary tissue conduit, passively transporting urine from the
ureters through a stoma, or hole in the abdomen, into a standard ostomy bag.
Standard of care for patients requiring a non-continent urinary diversion uses
bowel tissue to construct a conduit for urine to exit from the body. There are
over 20,000 urinary diversions performed annually in the United States and
Europe. These patients are at risk for complications associated with the use
of bowel tissue, as well as for those associated with the surgery to harvest
the bowel tissue. The Neo-Urinary Conduit is the only product candidate
currently in development that aims to avoid the use of bowel tissue. The
Neo-Urinary Conduit is being evaluated in an ongoing Phase 1 clinical trial 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. Seven patients have been
implanted with the Neo-Urinary Conduit to date and the Company is focused on
completing implantation of the remaining three patients in the trial by the
end of the first quarter of 2013.
About the Neo-Kidney Augment™
The Neo-Kidney Augment™ is intended to prevent or delay the need for dialysis
or kidney transplantation by catalyzing the regeneration of functional kidney
tissue in patients with advanced chronic kidney disease (CKD). This increase
in functional kidney mass could thereby delay or prevent the need for dialysis
or kidney transplant in patients with end stage renal disease (ESRD).
According to the United States Renal Data System, more than $27 billion in
Medicare costs each year are attributable to patients with ESRD and ESRD is
associated with an approximate 20% mortality rate per year, with the average
life expectancy of a patient initiating dialysis of approximately four years.
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.
Two of these preclinical models have been conducted for a sufficiently long
period of time to demonstrate durability and an impact on survival. Tengion
has filed a Clinical Trial Application (CTA) for the Neo-Kidney Augment with
the Medical Products Agency (MPA) in Sweden and anticipates submitting an IND
filing to the FDA during the second quarter of 2013.
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. An initial clinical trial is ongoing for the
Company's most advanced product candidate, 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. The Company's lead preclinical candidate is the
Neo-Kidney Augment™, which is designed to prevent or delay dialysis kidney
transplantation by increasing renal function in patients with advanced chronic
kidney disease. Tengion has worldwide rights to its product candidates.
Certain statements set forth above may constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995.
Statements using words such as anticipate, expect, project, intend, plan,
believe, words and terms of similar substance and any discussion of future
plans, actions, or events generally identify forward-looking statements.
Forward looking statements regarding the Company include but are not limited
to (i) plans to develop and commercialize its product candidates, including
the Neo-Kidney Augment and the Neo-Urinary Conduit; and (ii) expectations
regarding ongoing and planned preclinical studies, clinical trials and related
filings or submissions with regulatory authorities. Although Tengion believes
that these statements are based upon reasonable assumptions within the bounds
of its knowledge of its business and operations, there are a number of factors
that may cause actual results to differ from these statements. Tengion's
business is subject to significant risks and uncertainties and there can be no
assurance that actual results will not differ materially from expectations.
Factors which could cause actual results to differ materially from
expectations include, among others: (i) the FDA could place the Neo-Urinary
Conduit clinical trial on clinical hold; (ii) patients enrolled in the
Neo-Urinary Conduit clinical trial may experience adverse events, which could
delay the clinical trial or cause the Company to terminate the development of
its Neo-Urinary Conduit; (iii) the Company may have difficulty enrolling
patients in its clinical trials; (iv) data from the Company's ongoing
preclinical studies, including the proposed GLP program for the Neo-Kidney
Augment, may not continue to be supportive of advancing such preclinical
product candidates; and (v) the Company may be unable to progress its product
candidates that are undergoing preclinical testing, including the Neo-Kidney
Augment, into clinical trials and the Company may not be successful in
designing such clinical trials in a manner that supports development of such
product candidates. For additional factors which could cause actual results
to differ from expectations, reference is made to the reports filed by the
Company with the Securities and Exchange Commission under the Securities
Exchange Act of 1934, as amended. The forward looking statements in this
release are made only as of the date hereof and the Company disclaims any
intention or responsibility for updating predictions or expectations in this
SOURCE Tengion, Inc.
Contact: Investor and Media: Brian Davis, firstname.lastname@example.org,
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