Feb 4 Rockwell Medical Inc reported
positive results from a clinical study of its iron deficiency
treatment for patients on hemodialysis.
The company's shares, which rose 25 percent in early
trading, later pared some gains to trade up 4 percent at $6.70.
The study was not part of Rockwell's pivotal program to get
U.S. Food and Drug Administration approval for the drug, company
spokesman David Connolly said. He said Rockwell would use the
results to market the drug if approved.
The drug, Soluble Ferric Pyrophosphate (SFP), is being
tested in two late-stage trials as a treatment for iron
deficiency in patients on hemodialysis - the process of removing
wastes and extra fluid from the blood of patients with kidney
Rockwell said the study results announced on Monday showed
regular administration of its treatment reduced the need for
erythropoietin stimulating agents (ESAs), which are used to
stimulate red blood cell production, by 37 percent.
"This doesn't get them any closer to the approval," said
Zacks Investment Research analyst Brian Marckx.
"This essentially says that SFP may not necessarily be
inferior to intravenous (IV) iron in reducing the amount of ESA
used. It doesn't say that it's better than IV iron," he said.
Results of the FDA-approved trials are expected in the
second half of 2013. Connolly said that Rockwell expected to
file for marketing approval by the end of the year.
Rockwell is also testing SFP in early-stage trials for three
other mediums of delivery - oral, peritoneal dialysis and total