Tengion Receives MPA Approval of CTA for Neo-Kidney Augment Phase 1 Trial in
WINSTON-SALEM, N.C., April 1, 2013
WINSTON-SALEM, N.C., April 1, 2013 /PRNewswire/ --Tengion, Inc. (OTCQB:
TNGN), a leader in regenerative medicine, today announced the acceptance of
the Company's Clinical Trial Application (CTA) filed with the Medical Products
Agency (MPA) in Sweden to initiate a Phase 1 clinical trial to evaluate the
safety and delivery of its Neo-Kidney Augment™ product in up to five patients
with advanced chronic kidney disease (CKD).
"We are excited to have received MPA approval for the Neo-Kidney Augment Phase
1 trial in Sweden and expect to initiate the trial this quarter. We will use
the data from this trial to establish safety and a delivery approach for our
planned U.S. Phase 1 trial, which we expect to start in the fourth quarter of
2013. We are confident that the Neo-Kidney Augment can truly benefit CKD
patients in need of transformative, life-changing technologies," said John L.
Miclot, President and Chief Executive Officer of Tengion.
Tengion's 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 CKD patients. The Phase 1 trial will involve delivery of an
active regenerative dose of Neo-Kidney Augment in patients with CKD. The trial
is expected to enroll up to 5 patients in 2013 and will follow each patient
for up to 2 years.
This CTA acceptance follows Tengion's inspection by an Official Qualified
Person for regulatory compliance with European Medicines Agency standards for
clinical manufacturing, processes, management, and quality programs. Following
the successful inspection, the Company was issued a Declaration of Compliance
to enable clinical production of the Neo-Kidney Augment at its cGMP
manufacturing facility located in Winston-Salem, North Carolina.
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's
Clinical Trial Application for the Neo-Kidney Augment has been approved by the
Medical Products Agency and initiation of the clinical trial in Sweden is
expected in the second quarter of 2013. Additionally, the Company plans to
file an IND to the U.S. FDA during the second quarter of 2013, with a U.S.
trial initiation planned for the fourth 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 plans to initiate a Phase 1 clinical
trial in Sweden during the second quarter of 2013 for 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-Urinary Conduit and the Neo-Kidney Augment; 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 U.S. Food and Drug Administration
could place the Neo-Urinary Conduit clinical trial on clinical hold; (ii) the
Medical Products Agency could place the Neo-Kidney Augment clinical trial on
clinical hold; (iii) patients enrolled in the Neo-Urinary Conduit or
Neo-Kidney Augment clinical trials may experience adverse events, which could
delay one of the clinical trials or cause the Company to terminate the
development of one of its product candidates; (iv) the Company may have
difficulty enrolling patients in its clinical trials; (v) data from the
Company's ongoing preclinical studies, including the GLP program for the
Neo-Kidney Augment, may not continue to be supportive of advancing such
preclinical product candidates; and (vi) the Company may be unable to progress
its product candidates that are undergoing preclinical testing 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 release.
SOURCE Tengion, Inc.
Contact: Investor and Media: Brian Davis, firstname.lastname@example.org,
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