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Benephit Infusion System To Be Studied in Patients With Chronic Kidney Disease Undergoing Cardiovascular Procedures

Posted on: Tuesday, 15 March 2005, 18:00 CST

FlowMedica, Inc.: Latest in Series of Trials to Assess Intra-Renal Drug Delivery for the Prevention of Life-Threatening Condition

AT A GLANCE

-- FlowMedica, Inc., announces the initiation of a randomized, placebo-controlled trial to assess targeted renal therapy (TRT) with its Benephit Infusion System in patients with chronic kidney disease. TRT is the delivery of medications and other therapeutic agents directly to the kidneys.

-- Investigators will determine if TRT via the Benephit system decreases the incidence of a life-threatening kidney condition called radiocontrast nephropathy (RCN) that can occur after minimally invasive cardiovascular procedures such as angioplasty, stenting and angiography.

-- It is estimated that 20 percent of patients who undergo coronary interventions could benefit from TRT for the condition.

FlowMedica, Inc., today announced the Scripps Clinic's initiation of a physician-sponsored clinical trial of the company's Benephit(TM) Infusion System in patients with chronic kidney disease who are undergoing cardiovascular procedures and are at increased risk for developing a potentially life-threatening condition called radiocontrast nephropathy (RCN). In the trial, investigators will assess whether using the Benephit system to deliver medication directly to the kidneys (targeted renal therapy or TRT) decreases the incidence of RCN, a reaction to the contrast media used in some procedures.

TRT delivers medications and other therapeutic agents directly to the kidneys and is an alternative to the standard delivery of systemic intravenous (IV) infusions to treat kidney dysfunction related to cardiovascular disease. Systemic infusions often are associated with serious side effects such as hypotension (severely low blood pressure), limiting the use of some drugs.

The study is the latest in a recent series of clinical trials at Scripps to evaluate TRT using the Benephit system.

Radiocontrast nephropathy (RCN) develops in patients whose kidneys are unable to withstand the harmful effects of the dye (radiocontrast media) used during minimally invasive procedures such as angioplasty, stenting and angiography. RCN developed in nearly 1 in 5 patients with chronic kidney disease undergoing coronary interventions and led to a significantly higher death rate, according to a recent study.(1)

This latest randomized, placebo-controlled trial is being coordinated by Scripps Clinic, La Jolla, Calif., under the direction of principal investigator Paul Teirstein, M.D., FACC, director of interventional cardiology at Scripps Clinic. Scripps is currently enrolling patients with chronic kidney disease in the trial, which will have as many as 30 patients.

"People with chronic kidney disease are at significant risk for developing RCN after minimally invasive therapy, but treatment options are limited," said Dr. Teirstein. "We are evaluating the premise that TRT with the Benephit Infusion System may allow these patients to undergo potentially life-saving therapies with less risk."

Researchers believe the contrast media used in minimally invasive cardiovascular procedures causes a reaction that results in the narrowing of the kidney's arteries (renal vasoconstriction) and that this vasoconstriction plays a major role in the development of RCN, which, in turn, compromises kidney function.

Dr. Teirstein said the trial will assess the premise that TRT using the Benephit system to deliver nesiritide (a potent vasodilator) to the kidneys will improve renal function and blood flow by delivering more drug to the kidneys than is safely possible with standard systemic IV infusion. It is theorized that there is a low risk of hypotension with TRT since much less of the drug is delivered throughout the body than is the case with IV infusion. The study also will evaluate whether TRT with nesiritide using the Benephit system decreases the incidence of RCN, as measured by blood levels of a chemical waste molecule called creatinine - a direct indication of kidney function. Researchers also will investigate whether targeted delivery of nesiritide to the kidneys will effectively suppress certain hormones in the body that reduce the flow of blood to the kidneys.

Nesiritide is a recombinant form of B-Type Natriuretic Peptide (BNP), a naturally occurring hormone that is a vasodilator, and has the ability to improve kidney function and blood flow in humans. It is approved by the U.S. Food and Drug Administration (FDA) for the intravenous treatment of patients with acutely decompensated congestive heart failure.

It is estimated that 20 percent of patients undergoing coronary interventions could benefit from TRT for RCN.

The Benephit Infusion System is an FDA 510(k)-cleared novel, proprietary selective infusion catheter system for TRT.

A previous randomized, placebo-controlled, physician-sponsored clinical trial at Scripps and St. Joseph's Medical Center in Stockton, Calif., evaluated the intra-renal delivery of another vasodilator, fenoldopam, using TRT with the Benephit system in patients at lesser risk for RCN. Investigators found that patients who received TRT had significantly improved kidney function, while those who received systemic IV administration of the fenoldopam did not demonstrate improvement relative to placebo. Furthermore, blood levels of fenoldopam and unwanted side effects were significantly less with TRT compared to standard systemic IV treatment.

Another randomized, placebo-controlled physician-sponsored clinical study at Scripps will evaluate TRT using fenoldopam via the Benephit system in patients at very high risk for RCN, diabetics with moderate or severe renal dysfunction. The trial is under way and is enrolling 64 patients.

About FlowMedica

FlowMedica is a venture-backed, privately held commercial-stage medical device company founded in 2002 by Accelerated Technologies, Inc., in collaboration with leading cardiologists and surgeons. The company, located in Fremont, Calif., is developing minimally invasive intravascular systems to treat kidney dysfunction related to certain interventional or surgical procedures and diseases. FlowMedica has raised a total of $15.3 million to date in three rounds of private equity financing.

FlowMedica's initial product, the Benephit Infusion System, received 510(k) clearance from the FDA in January 2004 and CE marking in February 2005 for the infusion of physician-specified agents in the peripheral vasculature including, but not limited to, the renal arteries. (1) Dangas G, Iakovou I, Nikolsky E, et al. Contrast-induced nephropathy after percutaneous coronary interventions in relation to chronic kidney disease and hemodynamic variables. American Journal of Cardiology. 2005;95:13-19.

Source: Business Wire

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