Proteon Therapeutics Announces Survey Findings Demonstrating Impact of Vascular Access Failure on Hemodialysis Patients

April 28, 2016
Poster Presentation at the National Kidney Foundation's 2016 Spring Clinical Meeting

WALTHAM, Mass., April 28, 2016 (GLOBE NEWSWIRE) -- 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 data from a survey of hemodialysis patients, which evaluated the impact of vascular access failure, will be presented in a poster at the National Kidney Foundation's Spring Clinical Meetings being held in Boston, April 27May 1, 2016. The survey found that arteriovenous fistula (AVF) failure frequently resulted in one or more missed dialysis sessions.

An AVF, which is a surgically created connection between an artery and a vein, is the preferred form of vascular access, enabling a patient with chronic kidney disease (CKD) to undergo life-sustaining hemodialysis. AVFs are susceptible to failure, which occurs when an AVF has insufficient blood flow for hemodialysis, most often due to a blockage in the blood vessels of the AVF. AVF failure can result in additional surgical or other corrective procedures, such as balloon angioplasty, and reduced AVF survival.

The poster describes the results of a survey of 60 hemodialysis patients who had previously experienced a failure of their AVF. The survey found that 36% of the patients experienced a missed dialysis session due to AVF failure with a resulting extended interdialytic gap period of at least 2 days and 18% of patients experienced an extended interdialytic gap of at least 3 days. The interdialytic gap is the number of days between hemodialysis treatment sessions. In previous research (Foley, NEJM, 2011), 2 day interdialytic gap periods have been associated with increased rates of morbidity and mortality.   

The poster, number 305, "Consequences for Dialysis Patients Suffering Vascular Access Failure", will be available for viewing in the Exhibit Hall at the Hynes Convention Center beginning with the Opening Ceremonies on April 28 from 6:00pm ET7:30pm ET. An abstract of the poster will be published in a supplemental issue of the American Journal of Kidney Diseases.

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 require hemodialysis and need a high-flow vascular access to repeatedly connect the patient's bloodstream to a hemodialysis machine for this life-saving, chronic treatment. Three times per week for three to four hours each session, blood is pumped from the body and passed through a dialysis machine that removes waste and excess water normally excreted by the kidneys. The preferred form of vascular access, used by two-thirds of hemodialysis patients in the United States, is an arteriovenous fistula (AVF). An AVF is created when a surgeon connects a vein to an artery, typically at the wrist or elbow, resulting in a substantial increase in blood flow and vein dilation. A radiocephalic AVF is created between the radial artery and cephalic vein at the wrist.

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 (formerly PRT-201), is an investigational drug intended to improve arteriovenous fistula (AVF) patency, the period of time during which an AVF remains open with adequate blood flow to enable hemodialysis. Proteon is currently evaluating vonapanitase in two Phase 3 clinical trials (PATENCY-1 and PATENCY-2) in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic AVF for hemodialysis and has completed a Phase 1 clinical trial in patients with symptomatic peripheral artery disease (PAD). For more information, please visit

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 "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately," "potential," or, in each case, their negatives or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements, including when the Company expects to report top-line data from the PATENCY-1 Phase 3 clinical study, the number of patients to be enrolled in and the timing of completion of enrollment in the PATENCY-2 Phase 3 clinical study of vonapanitase, the potential surgical and endovascular applications for vonapanitase, the potential treatment of renal and vascular diseases with vonapanitase, the effect of vonapanitase in patients with CKD, whether vonapanitase improves AVF patency 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 clinical trials 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 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, 2015, as filed with the Securities and Exchange Commission on March 14, 2016, and our 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 Contact
George Eldridge, Proteon Therapeutics, Senior Vice President and Chief Financial Officer

Media Contact
Chris Erdman, MacDougall Biomedical Communications

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