Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Rockwell Medical's Iron Delivery Drug Meets Primary Endpoint In Phase 3 Study

RELATED NEWS
Trade RMTI now with 

Rockwell Medical (RMTI: Quote) Monday said, Soluble Ferric Pyrophosphate, or SPF, an investigational iron-delivery drug, met primary endpoint in the Phase 3 clinical studies for the treatment of iron deficiency in hemodialysis patients.

The primary endpoint of the randomized, double-blinded, multi-center study was to determine whether regular administration of SFP via dialysate reduced the requirement for ESA dose by maintaining iron balance and optimizing iron delivery.

The PRIME study demonstrated that regular administration of SFP-iron via dialysate reduced the usage of erythropoietin stimulating agents during hemodialysis by 37.1 percent while maintaining iron balance and maximizing iron delivery.

The 11 microgram/dL SFP dose was found to deliver sufficient iron without increasing iron stores while greatly reducing ESA dose, with a safety profile similar to placebo.

A 37 percent higher ESA dose was needed in the placebo arm to maintain hemoglobin compared to the SFP arm, but in the Phase 3 CRUISE efficacy studies the ESA dose is kept constant, unable to be titrated, over the 12-month study period.

SFP's ability to substantially reduce ESA use in the treatment of anemia should translate into significant cost savings in dialysis care while potentially lowering the serious risks associated with the dosing of ESAs.

A total of 32 patients received rescue IV iron, 20 in placebo and 12 in SFP. Further analysis of the complete data set is ongoing and the Company plans to submit PRIME data results for presentation at a major medical meeting later in 2013.

The upcoming efficacy results from the Phase 3 CRUISE studies are expected to read-out in the 2nd-half of 2013.

Register
To receive FREE breaking news email alerts for Rockwell Medical Technologies Inc and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
After moving modestly higher in morning trading, stocks showed a substantial move to the downside over the course of the trading day on Wednesday. The major averages pulled back well off their highs for the session, sliding firmly into negative territory. Ebola "czar" Ron Kain is scheduled to meet with President Barack Obama on Wednesday as he begins his efforts to coordinate the government's response to the deadly disease. Klain, who previously served as chief of staff to Vice President Joe Biden and then-Vice President Al Gore, was named as Ebola Response Coordinator last Friday. Potentially complicating the outlook for control of the Senate, the results of a SurveyUSA poll conducted for WXIA-TV in Atlanta suggest that the Georgia Senate race between Republican David Perdue and Democrat Michelle Nunn could be headed for a runoff.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.