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PROTEON THERAPEUTICS INC filed this Form S-1/A on 10/07/2014
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Primary Unassisted Patency—Radiocephalic AVFs


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

10 micrograms
30 micrograms

Number of Patients

  N=23   N=20

Unadjusted Risk vs. Placebo

  -41% (p=0.18)   -63% (p=0.02)

Adjusted Risk(1) vs. Placebo

  -40% (p=0.20)   -61% (p=0.04)

Note:    Not prespecified analysis.

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

        Brachiocephalic AVFs.    The benefit of PRT-201 on primary unassisted patency was less pronounced in the subset of patients undergoing placement of a brachiocephalic AVF. This was in part due to an uneven distribution between brachiocephalic AVF groups in the number of patency loss events occurring in the central veins and cephalic arch, also known as central stenosis, which are remote from the site of the AVF. Patency loss in brachiocephalic AVFs occurs due to central stenosis 50% of the time. Central stenoses commonly exist prior to surgery due to the venous anatomy or scarring from a prior hemodialysis catheter, but are typically unmasked following placement of the higher blood flow brachiocephalic AVFs. Since PRT-201 is active locally at the site where it is applied on the AVF, and because we have demonstrated that PRT-201 is not active remotely, we believe that central stenoses are unrelated to PRT-201. Therefore, to correct for this uneven distribution, we conducted a non-prespecified analysis of the primary endpoint in brachiocephalic AVFs which excluded patency loss events due to central stenoses. The following table summarizes the risk of primary unassisted patency loss in brachiocephalic AVFs including and then excluding patency loss events related to central stenoses.