Proteon Therapeutics Receives FDA Breakthrough Therapy Designation for Vonapanitase
May 10 2017 - 7:30AM
Proteon Therapeutics, Inc. (Nasdaq:PRTO), a company developing
novel, first-in-class therapeutics to address the medical needs of
patients with kidney and vascular diseases, today announced that
its investigational treatment, vonapanitase, has received
Breakthrough Therapy designation from the U.S. Food and Drug
Administration (FDA) for increasing arteriovenous fistula secondary
patency (i.e., survival of the fistula without abandonment) and use
for hemodialysis in patients on or expected to initiate
hemodialysis.
Secondary patency and fistula use for hemodialysis are the
co-primary endpoints of Proteon’s ongoing pivotal Phase 3 clinical
trial, PATENCY-2. As previously announced, the FDA has confirmed
that the PATENCY-2 trial together with data from previously
completed studies would provide the basis for a Biologics License
Application (BLA) submission as a single pivotal study if PATENCY-2
is successful in showing statistical significance (p≤0.05) on each
of the co-primary endpoints.
The FDA awards Breakthrough Therapy designations to expedite the
development and review of drugs that are intended to address a
serious or life-threatening condition and preliminary clinical
evidence indicates that the drug may offer a substantial
improvement over available therapies on one or more clinically
significant endpoints. Proteon’s Breakthrough Therapy
designation is supported by data from PATENCY-1, the Company’s
first Phase 3 clinical trial evaluating vonapanitase in patients
with chronic kidney disease (CKD) undergoing surgical creation of a
radiocephalic arteriovenous fistula. In that study, vonapanitase
demonstrated clinically meaningful improvements in secondary
patency and use for hemodialysis, although it did not meet the
primary endpoint of improving primary patency.
“We believe the decision by the FDA to grant vonapanitase a
Breakthrough Therapy designation speaks to the clinical importance
of fistula survival and use for hemodialysis to patients with
chronic kidney disease,” said Timothy Noyes, President and Chief
Executive Officer of Proteon Therapeutics. “Our productive ongoing
dialogue with the FDA has helped to create a clear path forward for
vonapanitase, and we look forward to continuing to work closely
with the FDA to expedite our development efforts for this important
program.”
Enrollment in the PATENCY-2 trial is expected to complete in the
first quarter of 2018 and Proteon expects to report top-line data
in the first quarter of 2019. Proteon also expects to submit
a BLA to the FDA in 2019.
About Chronic Kidney Disease, Hemodialysis and Vascular
Access
In 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
forearm, resulting in a substantial increase in blood flow and vein
dilation.
About Vonapanitase
Vonapanitase 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
program in patients with 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 Therapeutics
Proteon 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
is currently enrolling patients 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 of vonapanitase in patients with PAD. For more
information, please visit www.proteontx.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains statements that are, or may be
deemed to be, "forward-looking statements." 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 timing of
enrollment in the PATENCY-2 trial, when the Company expects to
report top-line data from the PATENCY-2 trial, whether and when we
may submit a BLA, whether additional studies will be necessary to
support a BLA submission as a single pivotal trial, the potential
treatment of renal and vascular diseases with vonapanitase, the
effect or benefit of vonapanitase in patients with CKD, whether
vonapanitase improves secondary patency or fistula use for
hemodialysis and the clinical importance of these endpoints, 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 our 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 we can successfully
commercialize and market our product candidates, are described more
fully in our Annual Report on Form 10-K for the year ended December
31, 2016, as filed with the Securities and Exchange Commission
(“SEC”) on March 16, 2017, and our 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 our forward-looking statements, you should not place undue
reliance on these statements or regard these statements as a
representation or warranty by us or any other person that we will
achieve our objectives and plans in any specified time frame, or at
all. The forward-looking statements contained in this press release
represent our estimates and assumptions only as of the date of this
press release and, except as required by law, we undertake 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 Relations ContactGeorge Eldridge,
Proteon Therapeutics, Senior Vice President and Chief Financial
Officer781-890-0102geldridge@proteontherapeutics.com
Media ContactAnn Stanesa, Ten Bridge
Communications617-230-0347proteon@tenbridgecommunications.com
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