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.
Pro Pharma (PRWP.OB) announced yesterday that it has entered a consulting agreement with Perceptive Imagineering to represent the Company in Central and South America for the licensing and distribution of DAVANAT throughout the region (starting in Colombia) to treat colorectal cancer in combination with approved chemotherapy drugs. PRWP expects to finalize an export license and secure a distribution partner in the region as part of its ex-US commercialization strategy for DAVANAT in addition to seeking new partnerships with international distribution and bio-pharma companies. Click here for my recent overview article on PRWP at BioMedReports.com.
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