Proteon Therapeutics Inc. (Nasdaq: PRTO), a company developing
novel, first-in-class pharmaceuticals to address the medical needs
of patients with kidney and vascular diseases, today announced the
publication in the Journal of Vascular Surgery of results from its
Phase 3 PATENCY-1 clinical trial of investigational vonapanitase.
Top-line data from PATENCY-1 were publicly announced in December
2016. The study results suggested vonapanitase may improve both
fistula use for hemodialysis and secondary patency (time to fistula
abandonment), which are the co-primary endpoints in Proteon’s
ongoing Phase 3 PATENCY-2 clinical trial. The PATENCY-2 clinical
trial is fully enrolled and top-line data is expected in March
2019.
PATENCY-1 evaluated the safety and efficacy of a single dose of
vonapanitase in patients with chronic kidney disease (CKD)
undergoing surgical creation of a radiocephalic arteriovenous
fistula for hemodialysis. The randomized, double-blind,
placebo-controlled clinical trial enrolled 313 treated patients at
31 medical centers in the United States. Patients were followed for
up to one year.
As previously reported, PATENCY-1 did not meet its primary
endpoint of improved primary unassisted patency, compared to
placebo (p=0.254). However, for its pre-specified secondary
endpoint, the trial showed a 34% reduction in the risk of secondary
patency loss over one year, compared to placebo (p=0.048).
Additionally, the trial showed a 45% relative increase in fistula
use for hemodialysis, compared to placebo (p=0.006), which was
another pre-specified endpoint.
“While a functioning arteriovenous fistula remains the gold
standard for hemodialysis vascular access, failure rates remain
unacceptably high, resulting in increased morbidity and mortality
and higher health care costs,” said Anthony J. Bleyer, M.D.,
Professor, Nephrology, Wake Forest Baptist Health, and lead author
of the publication. “The PATENCY-1 results are promising because of
the improvement in fistula use and secondary patency, two
clinically meaningful endpoints for patients, their families, and
their physicians. I look forward to the results of the ongoing
PATENCY-2 trial, in which fistula use and secondary patency are the
co-primary endpoints.”
The PATENCY-1 results were the basis for Proteon’s request to
the U.S. Food and Drug Administration (FDA) for Breakthrough
Therapy designation, which the FDA granted in May 2017 for
increasing arteriovenous fistula secondary patency and use for
hemodialysis. The FDA awards Breakthrough Therapy designations to
expedite the development and review of investigational drugs that
are intended to address a serious or life-threatening condition
when preliminary clinical evidence indicates that the drug may
offer a substantial improvement over available therapies on one or
more clinically significant endpoints.
Based on the results of PATENCY-1, and following discussions
with the FDA, Proteon amended the protocol for the PATENCY-2 trial,
reordering the endpoints and establishing fistula use for
hemodialysis and secondary patency as co-primary endpoints. If
PATENCY-2 is successful in showing statistical significance
(p≤0.05) for both of the co-primary endpoints, Proteon expects to
file a Biologics License Application (BLA) with the FDA in the
second half of 2019 and a Marketing Authorization Application (MAA)
with the European Medicines Agency (EMA) in the first half of
2020.
About Chronic Kidney Disease, Hemodialysis and Vascular
AccessIn the most severe stage of chronic kidney disease
(CKD), also known as kidney failure, the kidneys can no longer
function to sustain life. The majority of patients with kidney
failure undergo chronic hemodialysis, which requires a high-flow
vascular access to repeatedly connect the patient's bloodstream to
a hemodialysis machine for this life-saving treatment. The
preferred form of vascular access for hemodialysis is a
radiocephalic arteriovenous fistula, created when a surgeon
connects a vein to an artery in the lower arm, resulting in a
substantial increase in blood flow and vein dilation.
About VonapanitaseVonapanitase is an
investigational drug intended to improve hemodialysis vascular
access outcomes. Vonapanitase is applied in a single administration
and is currently being studied in a Phase 3 clinical trial in
patients with chronic kidney disease (CKD) undergoing surgical
creation of a radiocephalic arteriovenous fistula for hemodialysis.
Vonapanitase has received Breakthrough Therapy, Fast Track and
Orphan Drug designations from the FDA, and Orphan Medicinal Product
designation from the European Commission, for hemodialysis vascular
access indications. In addition, vonapanitase may have other
surgical and endovascular applications in diseases or conditions in
which vessel injury leads to blockages in blood vessels and reduced
blood flow. Proteon is currently conducting a Phase 1 clinical
trial of vonapanitase in patients with peripheral artery disease
(PAD).
About Proteon TherapeuticsProteon Therapeutics
is committed to improving the health of patients with kidney and
vascular diseases through the development of novel, first-in-class
therapeutics. Proteon's lead product candidate, vonapanitase, is an
investigational drug intended to improve hemodialysis vascular
access outcomes. Proteon has completed enrollment in PATENCY-2, a
Phase 3 clinical trial evaluating vonapanitase in patients with CKD
undergoing surgical creation of a radiocephalic arteriovenous
fistula for hemodialysis. Proteon is also evaluating vonapanitase
in a Phase 1 clinical trial in patients with PAD. For more
information, please visit www.proteontx.com.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains statements that are,
or may be deemed to be, "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. In some
cases, these forward-looking statements can be identified by the
use of forward-looking terminology, including the terms
“estimates,” “anticipates,” "expects,” “plans,” "intends,” “may,”
or “will,” in each case, their negatives or other variations
thereon or comparable terminology, although not all forward-looking
statements contain these words. These statements, including the
number of patients to be enrolled in and the timing of enrollment
in the Company’s ongoing Phase 1 clinical trial of vonapanitase in
patients with PAD, when the Company expects to release top-line
data from the PATENCY-2 trial, whether and when the Company may
submit a Biologics License Application in the United States or
Marketing Authorization Application in Europe, the effect or
benefit of vonapanitase in patients with CKD, whether vonapanitase
improves fistula use for hemodialysis or secondary patency, the
potential surgical and endovascular applications for vonapanitase,
including PAD, and those relating to future events or our future
financial performance or condition, involve substantial known and
unknown risks, uncertainties and other important factors that may
cause our actual results, levels of activity, performance or
achievements to differ materially from those expressed or implied
by these forward-looking statements. These risks, uncertainties and
other factors, including whether our cash resources will be
sufficient to fund the Company’s operating expenses and capital
expenditure requirements for the period anticipated; whether data
from early nonclinical or clinical studies will be indicative of
the data that will be obtained from future clinical trials; whether
vonapanitase will advance through the clinical trial process on the
anticipated timeline and warrant submission for regulatory
approval; whether such a submission would receive approval from the
U.S. Food and Drug Administration or equivalent foreign regulatory
agencies on a timely basis or at all; and whether the Company can
successfully commercialize and market its product candidates, are
described more fully in our Annual Report on Form 10-K for the year
ended December 31, 2017, as filed with the Securities and Exchange
Commission (“SEC”) on March 14, 2018, and the Company’s subsequent
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as
filed with the SEC, particularly in the sections titled “Risk
Factors” and “Management's Discussion and Analysis of Financial
Condition and Results of Operations.” In light of the significant
uncertainties in the Company’s forward-looking statements, no
person should place undue reliance on these statements or regard
these statements as a representation or warranty by the Company or
any other person that the Company will achieve its objectives and
plans in any specified time frame, or at all. The forward-looking
statements contained in this press release represent the Company’s
estimates and assumptions only as of the date of this press release
and, except as required by law, the Company undertakes no
obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise after the date of this press release.
Investor Contact George Eldridge, Proteon
Therapeutics, Senior Vice President and Chief Financial Officer
781-890-0102 geldridge@proteontherapeutics.com
Media Contact Ann Stanesa, Ten Bridge
Communications 617-230-0347
proteon@tenbridgecommunications.com
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