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S-1
PROTEON THERAPEUTICS INC filed this Form S-1 on 09/16/2014
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Table of Contents

Reduction in Risk of Primary Unassisted Patency Loss vs. Placebo—Brachiocephalic AVFs

 
  PRT-201
10 micrograms
  PRT-201
30 micrograms

Number of Patients

  N=28   N=29

Unadjusted Risk vs. Placebo

  -14% (p=0.72)   +10% (p=0.82)

Unadjusted Risk vs. Placebo Excluding Central Stenoses

  -12% (p=0.76)   -26% (p=0.46)

Note:    Not prespecified analysis.

        We also conducted a non-prespecified analysis across all patients of the primary endpoint correcting for this uneven distribution in central stenoses. The following Kaplan-Meier curves for primary unassisted patency for all AVFs (excluding central stenoses) and table demonstrate a significant reduction in the risk of primary unassisted patency loss for the 30 microgram dose (p=0.04, for the 30 microgram dose) versus placebo. Treatment with PRT-201 at doses of 10 and 30 micrograms was associated with a reduction of 31% and 48%, respectively, in the risk of primary unassisted patency loss. After adjusting for differences in baseline characteristics associated with the risk of primary unassisted patency loss, treatment with PRT-201 at doses of 10 and 30 micrograms was associated with a reduction of 25% and 52%, respectively, in the risk of primary unassisted patency loss.

Primary Unassisted Patency—All AVFs
(Excluding Central Stenoses)

CHART

Reduction in Risk of Primary Unassisted Patency Loss vs. Placebo—All AVFs
(Excluding Central Stenoses)

 
  PRT-201
10 micrograms
  PRT-201
30 micrograms

Number of Patients

  N=51   N=49

Unadjusted Risk vs. Placebo

  -31% (p=0.20)   -48% (p=0.04)

Adjusted Risk vs. Placebo(1)

  -25% (p=0.33)   -52% (p=0.02)

Note:    Not prespecified analysis.

(1)
Adjusted for differences in baseline characteristics associated with the risk of primary unassisted patency loss between treatment groups using a prespecified Cox regression analysis.

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