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Rockwell Medical (NASDAQ:RMTI) announced yesterday that patient enrollment is completed for the Company's ongoing Phase 2b dose-ranging study for its iron replacement therapy soluble ferric pyrophosphate (SFP). Below is the entry from RMTI in the BioMedReports.com Clinical Trial Calendar database: RMTI is developing a water soluble iron replacement therapy for dialysis patients called SFP for short (Soluble Ferric Pyrophosphate). Results are expected during 1Q10 for a nine-month NIH study in 30 patients which compares SFP to IV iron replacement therapies. However, this is a non-FDA study and the data will not be considered as part of the application for marketing approval of SFP.
The Company's primary focus is completing enrollment in the Phase 2b study of SFP (expected by the end of March), which is a six-month, dose-ranging study to determine the safety parameters and optimal SFP concentration to maintain normal levels of iron and hemoglobin. The Phase 2b trial should be completed by the end of September and data should be released about 60 days later, which should occur in late November or early December. The Phase 3 clinical trial for SFP should begin some time during 4Q09-1Q10.
Below is a link to a 10-page PDF report, which is freely available to view or download in stock research section of BioMedReports.com here.
The full report is available at: http://biomedreports.com/articles/most-popular/833-fda-clinical-trial-calendar-updates-thor-alth.html
About BiomedReports.Com
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars plus a database that includes about 1,000 stocks and exchange-traded funds from the healthcare sector which are organized into various new healthcare stock indexes.
For more biomedical sector and investment news, go to BiomedReports.Com (http://www.BiomedReports.com )
Disclosure: No positions.
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