Proteon logo     Print Page | Close Window

SEC Filings

S-1
PROTEON THERAPEUTICS INC filed this Form S-1 on 09/16/2014
Entire Document
 

Table of Contents

        Patients completing 12 months of follow-up in the initial trial were followed in a registry to obtain additional data related to the efficacy endpoints. In this follow up, the PRT-201 benefit on procedure rates persisted out to 900 days as set out in the following table.

Average Procedure Rate to Restore/Maintain Patency Including Registry Data (p-Value vs. Placebo)

 
  Placebo   PRT-201
10 micrograms
  PRT-201
30 micrograms

All AVFs (Prespecified analysis)

           

Number of Patients

  N=51   N=50   N=48

Procedures per Year

  0.8   0.8 (p=0.61)   0.3 (p=0.03)

Radiocephalic AVFs (Non-prespecified analysis)

           

Number of Patients

  N=24   N=23   N=20

Procedures per Year

  1.0   0.8 (p=0.47)   0.2 (p=0.03)

Brachiocephalic AVFs (Non-prespecified analysis)

           

Number of Patients

  N=27   N=27   N=28

Procedures per Year

  0.7   0.8 (p=1.00)   0.4 (p=0.40)
    Secondary patency.  Secondary patency loss was defined as abandonment of the AVF, which typically occurs following loss of primary unassisted patency due to thrombosis or failure of a procedure to restore patency and leads to additional surgery to create a new vascular access. We observed no significant differences in the risk of secondary patency loss in the overall AVF population or the subset of patients receiving brachiocephalic AVFs. However, as seen in the Kaplan-Meier curves and table below, a trend toward prolonged secondary patency was seen in patients receiving radiocephalic AVFs. In this non-prespecified subset analysis, treatment with PRT-201 at doses of 10 and 30 micrograms was associated with reductions of 55% and 73%, respectively, in the risk of secondary patency loss.

Secondary Patency—Radiocephalic AVFs

CHART

 
  PRT-201
10 microgram dose
  PRT-201
30 microgram dose
 

Number of Patients

    N=23     N=20  

Unadjusted Risk vs. Placebo

    -55% (p=0.19)     -73% (p=0.08)
 

Note: Not prespecified analysis.

              Patients completing 12 months of follow-up in the initial trial were followed in a registry to obtain additional data related to the efficacy endpoints. In this follow-up, the PRT-201 benefit on secondary patency in radiocephalic AVFs persisted out to 900 days.

94