Proteon Therapeutics Announces Increase to Enrollment of Ongoing Phase 3 PATENCY-2 Clinical Trial
May 02 2017 - 4:40PM
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 it
will increase the planned enrollment of its ongoing Phase 3
PATENCY-2 trial to 600 patients. The increased sample size follows
a review of the statistical plan, which revealed a calculation
error that overstated the trial’s power for secondary patency, one
of the co-primary endpoints. The increased sample size provides 88%
power to detect the differences observed in the PATENCY-1 trial
with a p-value ≤0.05 for secondary patency, and 98% power with a
p-value ≤0.05 for fistula use for hemodialysis, the other
co-primary endpoint.
The increase in sample size does not alter the
study endpoints, which use the same definitions as in the PATENCY-1
trial.
- Secondary patency is defined as the length of
time from surgical creation until fistula abandonment (final
failure). In PATENCY-1, vonapanitase-treated patients experienced a
34% reduction in the risk of secondary patency loss over one year,
compared to placebo (p=0.048). At the end of one year, 74% of
vonapanitase-treated patients maintained secondary patency,
compared to 61% of placebo-treated patients.
- Use for hemodialysis is defined as use of the
fistula for hemodialysis for at least 90 days or, if hemodialysis
was not initiated at least 90 days prior to the patient’s last
visit, for at least 30 days prior to the patient’s last visit and
in use at the patient’s last visit. In PATENCY-1, 64% of
vonapanitase-treated patients used their fistula for hemodialysis,
compared to 44% of placebo-treated patients (p=0.006), a 45%
relative increase.
With this change in sample size, Proteon expects
to complete enrollment in the first quarter of 2018 and to report
top-line data in the first quarter of 2019. Proteon still expects
to submit a Biologics License Application (BLA) to the U.S. Food
and Drug Administration (FDA) in 2019.
Proteon received written confirmation from the
FDA that, if the PATENCY-2 trial is successful in showing
statistical significance (p≤0.05) on each of the co-primary
endpoints, the PATENCY-2 trial together with data from previously
completed studies would provide the basis for a BLA submission as a
single pivotal study.
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 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 chronic kidney disease
(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 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 number of
patients to be enrolled in and 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 in
the United States, 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 fistula patency or use for hemodialysis, 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 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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