posted 12/06/02
Israel's Keryx
Biopharmaceuticals is shepherding a drug through the final stages of U.S.
clinical trials that can reduce albumin levels and gives hope to the three to
four million U.S. diabetes sufferers who experience kidney failure along with
their diabetes.
The prognosis for patients suffering from what's known as end-stage kidney
disease is grim at present and their only hope for survival is through a
continuous regimen of kidney dialysis or from a kidney transplant.
Keryx didn't develop the drug, which it calls KRX-101 and which is known
generically as sulodexide. Sulodexide has been sold in Europe for 20 years as a
treatment for coronary heart disease, but Keryx ran across some promising early
test results for the drug for diabetes done by its Italian manufacturer, Alpha
Wasserman. The Israeli startup snapped up the licensing rights to sulodexide for
diabetic kidney failure, also known as diabetic nephropathy, with the intention
of conducting clinical trials in the United States.
In the early-stage tests, KRX-101 successfully reduced the albumin that is
released by the kidneys of nephropathy patients and continued to do so for a
period of four months after the patients stopped taking the drug. Albumin is a
protein that is retained if the kidneys are functioning properly and the
restoration of albumin retention is a sign that the drug is repairing damage to
the walls of the kidney, Cohen said.
Results in the first two stages of clinical trials have been so promising that
the U.S. Food and Drug Administration has awarded so-called fast-track status to
KRX-101 for Phase III clinical trials in order to speed approval.
Fast track means the drug can be approved for sale in the United States if Phase
III patients experience the same improved albumin retention as the patients in
earlier trials. Without fast-track status, Keryx would have to prove
statistically that the drug prolonged patients' lives, a process that could
stretch the trials out many years. In the meantime, many patients would lack
access to a drug that has been used safely in Europe for 20 years, albeit for a
different disease.
"The only problem (with fast track) is that all the clinical trials patients
want the drug and no one wants the placebo," Cohen said, since many people think
the FDA is tipping its hand that it thinks the potential benefits may far
outweigh the dangers by granting fast-track status.
Keryx estimates that sales of KRX-101 would be $1 billion a year in the United
States.
Source: Diabetes In Control Dot Com.
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