SALT LAKE CITY (CN) - A Utah inmate died just weeks away from freedom after a dialysis technician repeatedly no-showed, the Utah Corrections Department says.
     Ramon Estrada died April 5 of an apparent heart attack related to kidney failure.
     Medical staff and outside responders were preparing to transport Estrada from Utah State Prison to University Medical Center for treatment when he died, the prisons department said.
     Prisons spokeswoman Brooke Adams said that a preliminary review showed lack of dialysis treatment could be a contributing factor in Estrada's death.
     Estrada was scheduled to receive kidney dialysis at the prison's on-site treatment center, on Friday, April 3.
     But a technician with Sandy-based South Valley Dialysis, a University of Utah medical clinic, did not show at the prison on Friday or Saturday, the prisons department says.
     Six additional inmates who required dialysis treatment but had not received it were taken to the medical center for evaluation after Estrada died.
     Two inmates were reported to be in good condition and returned to the prison. Four were admitted for treatment, and three were returned to the prison on Monday evening. One remained hospitalized for another day.
     "The delayed response in ensuring that the inmates' received needed medical care is unacceptable," Adams said.
     An internal investigation is underway and expected to be completed in two weeks, Adams said Friday.
     The prison's medical director was placed on administrative leave pending the investigation's outcome.
     "The department has taken immediate action to improve communication with and oversight of the dialysis contract provider," Adams said.
     Steps include obtaining a schedule calendar with contact telephone numbers for dialysis technicians, requiring nursing staff to make contact with and receive post-treatment reports from the on-duty technician on dialysis days, improving chart notes about inmates' status and condition, and requiring timely notification to the charge nurse when a dialysis schedule changes or technician fails to show up.
     Estrada was jailed in 2005 on a rape conviction and had a parole date of April 21.
     The Immigration and Customs Enforcement Service had a detainer for Estrada, a Mexican national.

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The FDA has granted fast-track designation to cabozantinib (Cometriq) for treatment of patients with advanced renal cell carcinoma (RCC) who have received prior therapy, according to a release.

Developed by Exelixis, cabozantinib is currently being studied in METEOR, an ongoing phase III trial that looks at patients with metastatic RCC who experience disease progression upon treatment with at least one VEGFR tyrosine kinase inhibitor.

Subjects are randomized to either cabozantinib (60 mg) or everolimus (10 mg) daily, with primary endpoint as progression-free survival and secondary endpoint as overall survival and response rate.

Exelixis is also studying the effects of cabozantinib in CELESTIAL, another phase III trial for the treatment of second-line hepatocellular carcinoma.

Cabozantinib is currently approved by the FDA for treatment of progressive, metastatic medullary thyroid cancer.

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Portugal has the highest incidence rate of renal replacement therapy (RRT) for end-stage renal disease (ESRD) in Europe, and Montenegro has the lowest, recently published findings in the Clinical Kidney Journal show.

According to the 2012 European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Registry Annual Report, the overall unadjusted incidence and prevalence of patients receiving RRT for ESRD was 109.6 per million population (pmp) and 716.7 pmp (on December 31, 2012), respectively. The unadjusted incidence was 219.9 pmp in Portugal and 24.2 pmp in Montenegro. On December 31, 2012, Portugal also had the highest unadjusted prevalence (1670.2 pmp), and Ukraine had the lowest (146.7 pmp).

The ERA-EDTA Registry collected data from national and regional registries in 30 countries in Europe and from 20 other European countries without registries. The total coverage of the European population by the ERA-EDTA Registry was 71.3% in 2012.

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WALTHAM, Mass., April 13, 2015 (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 the results from the 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), will be presented at two international scientific conferences in April. The results were originally presented at the National Kidney Foundation's (NKF) 2015 Spring Clinical Meetings in March and are available on Proteon's website here.

Steven Burke, M.D., Proteon's Senior Vice President and Chief Medical Officer, will present the results at the following conferences:

• 9^th Congress of the Vascular Access Society. Dr. Burke will present the results at the late-breaking clinical trial session on Thursday, April 16, 2015, at 11:30 a.m. CEST in Barcelona.
• Charing Cross St George's Vascular Access Course. Dr. Burke will present the results on Wednesday, April 29, 2015, at 2:00 p.m. BST in London.

The Phase 2 multicenter, randomized, double-blind, placebo-controlled clinical study evaluated safety and efficacy of a single application of investigational vonapanitase delivered immediately after surgical creation of an arteriovenous fistula (AVF) for hemodialysis. Data from the long-term analysis demonstrated a trend of prolonged primary patency, the study's primary endpoint, and a statistically significant improvement in the rate of corrective procedures 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 who 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.

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.

Proteon is currently enrolling patients in a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical study of vonapanitase in chronic kidney disease (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.

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 those regarding the potential surgical and endovascular applications for vonapanitase, the timing of results of the Phase 1 study for patients with PAD, the potential treatment of renal and vascular diseases with vonapanitase, the effect of vonapanitase in patients with CKD and number of persons with CKD, timing of enrollment for the Phase 3 trial, timing for initiation of enrollment for the second Phase 3 trial, 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, 2014, as filed with the Securities and Exchange Commission on March 19, 2015, 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.

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