DALLAS, TX and WALTHAM, MA, USAI March 26, 2015 I Proteon Therapeutics Inc. (PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced positive results from a long-term analysis of more than three years of follow-up data from a Phase 2 study of its lead candidate, vonapanitase (formerly PRT-201). The study evaluated the safety and efficacy of vonapanitase, an investigational drug, in patients with chronic kidney disease (CKD) undergoing surgical creation of an arteriovenous fistula (AVF) for hemodialysis.
The Phase 2 multicenter, randomized, double-blind, placebo-controlled clinical study evaluated safety and efficacy of a single application of vonapanitase delivered immediately after surgical creation of an AVF. Data from the long-term analysis, to be presented at the National Kidney Foundation’s (NKF) 2015 Spring Clinical Meetings in Dallas, demonstrated a trend of prolonged primary patency, the study’s primary endpoint, and a statistically significant improvement in the rate of corrective procedures, a secondary endpoint, over more than three years of follow-up for the 30 mcg vonapanitase dose as compared to placebo. An analysis of the results in the subset of patients receiving a radiocephalic AVF, which was not pre-specified, showed statistically significant improvements in primary patency, secondary patency (AVF survival) and the rate of corrective procedures over more than three years of follow-up for the 30 mcg vonapanitase dose as compared to placebo. A radiocephalic AVF is the preferred form of hemodialysis vascular access and is currently being studied in a Phase 3 clinical trial of vonapanitase.
Patients that received vonapanitase reported adverse events related to the AVF comparable to placebo over more than three years. These events were consistent with the medical events experienced by chronic kidney disease patients undergoing surgical creation of an AVF.
Bradley Dixon, M.D., a nephrologist and Associate Professor of Medicine at the University of Iowa’s Department of Internal Medicine, will present the results in a late-breaking clinical trial session on Saturday, March 28, 2015, at 9 a.m. CDT at the Spring Clinical Meetings. The data are also available as a poster presentation at the meetings and on Proteon’s website here.
“These results suggest that a single treatment of vonapanitase immediately after radiocephalic AVF surgical creation may yield durable benefits for patients,” said Dr. Dixon. “A radiocephalic AVF is the preferred form of vascular access for hemodialysis patients, and the benefits of vonapanitase, if observed in pivotal Phase 3 studies, would have great clinical importance to patients and their caregivers.”
A functioning AVF, which is a surgically created connection between an artery and a vein, is a hemodialysis patient’s lifeline, enabling the patient to undergo life-sustaining hemodialysis. AVFs are susceptible to patency loss, which occurs when an AVF has insufficient blood flow for hemodialysis, most often due to a blockage in the blood vessels of the AVF. Patency loss can result in additional surgical or other corrective procedures, such as balloon angioplasty, and reduced AVF survival.
“The results from more than three years of follow-up extend the positive findings we observed at one year in the non-pre-specified subset analysis of patients undergoing surgical creation of radiocephalic AVFs — the same patient population we are studying in our ongoing Phase 3 clinical trial,” said Timothy Noyes, President and Chief Executive Officer of Proteon.
Proteon is currently enrolling patients in a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical study of vonapanitase in CKD patients undergoing surgical creation of a radiocephalic AVF for hemodialysis. The Company expects to complete enrollment by the end of 2015 and is anticipating initiating enrollment in a second Phase 3 clinical study in the second quarter of 2015. Proteon is also conducting an ongoing Phase 1 clinical study of vonapanitase in patients with symptomatic peripheral artery disease (PAD).
About Chronic Kidney Disease, Hemodialysis and Vascular Access
In the most severe stage of chronic kidney disease (CKD), also known as end stage renal disease (ESRD), the kidneys can no longer function to sustain life. The majority of ESRD patients 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.
About Vonapanitase
Vonapanitase (formerly PRT-201) is an investigational drug designed to improve arteriovenous fistula (AVF) patency, the period of time during which an AVF remains open with adequate blood flow to enable hemodialysis. Vonapanitase is applied in a single administration and is currently being studied in a Phase 3 clinical trial in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. Vonapanitase has received fast track and orphan drug designations from the U.S. Food and Drug Administration (FDA), and orphan medicinal product designation from the European Commission, for hemodialysis vascular access indications. Vonapanitase may have multiple surgical and endovascular applications in which vessel injury leads to blockages in blood vessels and reduced blood flow, and is currently being evaluated in a Phase 1 clinical trial in patients with symptomatic 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, vonapanitase (formerly PRT-201), is designed 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 a Phase 3 clinical trial in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis and a Phase 1 clinical trial in patients with symptomatic peripheral artery disease (PAD). For more information, please visit www.proteontherapeutics.com.
SOURCE: Proteon Therapeutics
Post Views: 135
DALLAS, TX and WALTHAM, MA, USAI March 26, 2015 I Proteon Therapeutics Inc. (PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced positive results from a long-term analysis of more than three years of follow-up data from a Phase 2 study of its lead candidate, vonapanitase (formerly PRT-201). The study evaluated the safety and efficacy of vonapanitase, an investigational drug, in patients with chronic kidney disease (CKD) undergoing surgical creation of an arteriovenous fistula (AVF) for hemodialysis.
The Phase 2 multicenter, randomized, double-blind, placebo-controlled clinical study evaluated safety and efficacy of a single application of vonapanitase delivered immediately after surgical creation of an AVF. Data from the long-term analysis, to be presented at the National Kidney Foundation’s (NKF) 2015 Spring Clinical Meetings in Dallas, demonstrated a trend of prolonged primary patency, the study’s primary endpoint, and a statistically significant improvement in the rate of corrective procedures, a secondary endpoint, over more than three years of follow-up for the 30 mcg vonapanitase dose as compared to placebo. An analysis of the results in the subset of patients receiving a radiocephalic AVF, which was not pre-specified, showed statistically significant improvements in primary patency, secondary patency (AVF survival) and the rate of corrective procedures over more than three years of follow-up for the 30 mcg vonapanitase dose as compared to placebo. A radiocephalic AVF is the preferred form of hemodialysis vascular access and is currently being studied in a Phase 3 clinical trial of vonapanitase.
Patients that received vonapanitase reported adverse events related to the AVF comparable to placebo over more than three years. These events were consistent with the medical events experienced by chronic kidney disease patients undergoing surgical creation of an AVF.
Bradley Dixon, M.D., a nephrologist and Associate Professor of Medicine at the University of Iowa’s Department of Internal Medicine, will present the results in a late-breaking clinical trial session on Saturday, March 28, 2015, at 9 a.m. CDT at the Spring Clinical Meetings. The data are also available as a poster presentation at the meetings and on Proteon’s website here.
“These results suggest that a single treatment of vonapanitase immediately after radiocephalic AVF surgical creation may yield durable benefits for patients,” said Dr. Dixon. “A radiocephalic AVF is the preferred form of vascular access for hemodialysis patients, and the benefits of vonapanitase, if observed in pivotal Phase 3 studies, would have great clinical importance to patients and their caregivers.”
A functioning AVF, which is a surgically created connection between an artery and a vein, is a hemodialysis patient’s lifeline, enabling the patient to undergo life-sustaining hemodialysis. AVFs are susceptible to patency loss, which occurs when an AVF has insufficient blood flow for hemodialysis, most often due to a blockage in the blood vessels of the AVF. Patency loss can result in additional surgical or other corrective procedures, such as balloon angioplasty, and reduced AVF survival.
“The results from more than three years of follow-up extend the positive findings we observed at one year in the non-pre-specified subset analysis of patients undergoing surgical creation of radiocephalic AVFs — the same patient population we are studying in our ongoing Phase 3 clinical trial,” said Timothy Noyes, President and Chief Executive Officer of Proteon.
Proteon is currently enrolling patients in a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical study of vonapanitase in CKD patients undergoing surgical creation of a radiocephalic AVF for hemodialysis. The Company expects to complete enrollment by the end of 2015 and is anticipating initiating enrollment in a second Phase 3 clinical study in the second quarter of 2015. Proteon is also conducting an ongoing Phase 1 clinical study of vonapanitase in patients with symptomatic peripheral artery disease (PAD).
About Chronic Kidney Disease, Hemodialysis and Vascular Access
In the most severe stage of chronic kidney disease (CKD), also known as end stage renal disease (ESRD), the kidneys can no longer function to sustain life. The majority of ESRD patients 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.
About Vonapanitase
Vonapanitase (formerly PRT-201) is an investigational drug designed to improve arteriovenous fistula (AVF) patency, the period of time during which an AVF remains open with adequate blood flow to enable hemodialysis. Vonapanitase is applied in a single administration and is currently being studied in a Phase 3 clinical trial in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. Vonapanitase has received fast track and orphan drug designations from the U.S. Food and Drug Administration (FDA), and orphan medicinal product designation from the European Commission, for hemodialysis vascular access indications. Vonapanitase may have multiple surgical and endovascular applications in which vessel injury leads to blockages in blood vessels and reduced blood flow, and is currently being evaluated in a Phase 1 clinical trial in patients with symptomatic 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, vonapanitase (formerly PRT-201), is designed 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 a Phase 3 clinical trial in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis and a Phase 1 clinical trial in patients with symptomatic peripheral artery disease (PAD). For more information, please visit www.proteontherapeutics.com.
SOURCE: Proteon Therapeutics
Post Views: 135
