No Safety Concerns for RMTI's SFP Iron Treatment

WIXOM, Mich., April 16, 2009 (GLOBE NEWSWIRE) -- Rockwell Medical Technologies, Inc. (NasdaqGM:RMTI - News), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ERSD), chronic kidney disease (CKD), and iron deficiency anemia, reported today that the independent Data Safety Monitoring Board (DSMB) providing oversight for the ongoing SFP Phase 2b dose-range study reviewed the unblinded cumulative interim study data and informed the Company that it has identified no safety concerns. The DSMB also determined there is no need to add the highest dose group of 20 ug/dl and recommended continuation of the study with the current five dose groups.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, ``We are again encouraged by the DSMB's favorable comments regarding our current SFP Phase 2b study. These recommendations from the DSMB suggest that the data from this study will meet the study objective of identifying the dose of SFP to be carried forward into the subsequent Phase 3 clinical program. We also expect to reach our target for completion of enrollment very soon, as screening for new patients has already met its objective and has been stopped. The successful completion of our SFP development program remains our top priority.''

SFP is a novel, investigational, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal healthy iron uptake. SFP is intended as a continuous maintenance treatment consisting of small doses administered with every dialysis session to maintain iron status tests stable within target, as per Kidney Disease Quality Outcomes Initiative (KDOQI) recommendations.

Clinical trials to date suggest that SFP delivered during each dialysis treatment, via the Company's dialysate, has the ability to maintain optimal iron balance and avoid liver toxicity while decreasing associated pharmaceutical intravenous (IV) iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. The total U.S. market for IV iron is approximately $500 million annually while global market potential is approximately $850 million.

From BioMedReports.com FDA and Clinical Trial Calendar: 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 in 100-120 patients 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 and RMTI has guided for adequate cash flow and liquidity to reach this point without the need for raising cash.

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