Key Developments: Rockwell Medical Technologies, Inc. (RMTI.O)
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9 Feb 2010
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Latest Key Developments
Rockwell Medical Technologies, Inc. Announces New Data On Iron-Delivery Drug SFP
Rockwell Medical Technologies, Inc. announced new in vitro data at the American Society of Nephrology (ASN) annual meeting in San Diego, CA on its drug candidate Soluble Ferric Pyrophosphate (SFP). The study evaluated the kinetics of iron transfer from SFP to apo-transferrin (apo-Tf). Results showed that all available iron present in SFP was delivered to both iron-binding sites on human apo-transferrin, rapidly and completely. Further, 50% of iron uptake was complete within one minute, while there was approximately 90% saturation of the iron-binding sites on transferrin, the blood plasma protein for iron ion delivery, within 10 minutes.
Rockwell Medical Technologies, Inc. Completes SFP Phase IIb Clinical Study
Rockwell Medical Technologies, Inc. announced that the last patient has completed the Phase IIb clinical study to investigate Soluble Ferric Pyrophosphate (SFP), the Company's investigational iron maintenance therapy. The Phase IIb, double-blinded, randomized, placebo-controlled, six month duration, dose ranging study enrolled patients at 29 sites in the U.S. and Canada. 131 ESRD patients receiving chronic hemodialysis were dosed at 0, 5, 10, 12, or 15 ug of SFP-derived iron per deciliter of dialysate. The objective of the study was to evaluate the safety of SFP at varying dose levels and to determine the optimal concentration of SFP for maintenance of hemoglobin in the target range by maintaining iron balance. Two Data Safety Monitoring Board reviews of interim study data did not identify any safety concerns nor necessitate any change in the study design or conduct, and the study advanced until the targeted patient enrollment was achieved.
Rockwell Medical Technologies, Inc. Announces To Present Abstract At American Society Of Nephrology Annual Meeting
Rockwell Medical Technologies, Inc. announced that an abstract on SFP, its lead drug candidate, has been accepted for presentation at the American Society of Nephrology (ASN). Data will be presented during the ASN meeting for the Company's investigational drug, SFP, which is being studied for the treatment of iron-deficiency anemia in ESRD patients. The new in-vitro data demonstrate that SFP-derived iron binds rapidly and completely within minutes to transferrin. Transferrin is the carrier protein that delivers iron directly to the bone marrow for hemoglobin generation in the human body. In contrast, current IV-iron carbohydrate complexes administered intravenously undergo uptake by the liver, spleen and lymph nodes (reticuloendothelial system) followed by processing and slow release of iron for use by the body. SFP's rapid and direct binding to transferrin is thought to have the potential to prevent or reduce iron-induced oxidative stress and iron acquisition by bacteria, while overcoming reticuloendothelial block and thereby improving responsiveness to erythropoiesis stimulating agents.
Rockwell Medical Technologies, Inc. Announces Closing Of $22 Million Registered Direct Offering Of Shares and Warrants
Rockwell Medical Technologies, Inc. announced that it has received gross proceeds of approximately $22.0 million, before deducting placement agents' fees and offering expenses, from the closing of the previously announced registered direct offering. In the offering, an aggregate of 2,840,000 shares of the Company's common stock and warrants to purchase up to 1,079,200 shares of common stock were sold to institutional investors, led by Deerfield Management as the lead investor. The purchase price per unit, consisting of one share and a warrant to purchase 0.38 shares, was $7.75. The warrants will have a five year term from the date of issuance, will be exercisable beginning six months after the date of issuance, and will be exercisable at a price of $9.55 per share. The shares of common stock and warrants were immediately separable and were issued separately. Rockwell anticipates that the net proceeds from the offering of approximately $20.5 million will be used for general corporate purposes, which may include funding of clinical trials and regulatory activities for soluble ferric pyrophosphate (SFP), the Company's licensed drug therapy to treat iron deficiency anemia in dialysis patients, and other research and development expenses, and general and administrative expenses. JMP Securities LLC served as lead placement agent and Wedbush Securities Inc. served as co-placement agents for the offering.
Rockwell Medical Technologies, Inc. Announces $22 Million Registered Direct Offering
Rockwell Medical Technologies, Inc. announced that it has obtained commitments from institutional investors to purchase an aggregate of 2,840,000 shares of Rockwell's common stock and warrants to purchase up to 1,079,200 shares of common stock in a registered direct offering for gross proceeds of approximately $22.0 million, before deducting placement agents' fees and estimated offering expenses. The purchase price per unit, consisting of one share and a warrant to purchase 0.38 shares, is $7.75. The warrants will have a five-year term from the date of issuance, will be exercisable beginning six months after the date of issuance, and will be exercisable at a price of $9.55 per share. Rockwell anticipates that the net proceeds from the offering of approximately $20.5 million will be used for general corporate purposes, which may include funding of clinical trials and regulatory activities for soluble ferric pyrophosphate, our licensed drug therapy for the delivery of iron supplementation for anemic dialysis patients, and other research and development expenses, and general and administrative expenses. The closing of this offering is expected to occur on or about October 5, 2009. JMP Securities LLC served as lead placement agent.
Rockwell Medical Technologies, Inc. Announces Patient Enrollment Complete for Phase 2b Dose Range Study
Rockwell Medical Technologies, Inc. announced that patient enrollment has been completed for it's ongoing Phase 2b dose-ranging study for its iron deficiency anemia drug soluble ferric pyrophosphate (SFP). The Phase 2b dose-ranging study is a six-month, controlled multi-center, double-blind study consisting of approximately 130 hemodialysis patients at multiple dialysis centers in the United States and Canada. Subjects are randomized to receive one of several concentrations of SFP or placebo in dialysate during their normal three times/week dialysis regimen. The primary objectives of the study are to evaluate both safety and efficacy of SFP at varying dose levels and to determine the optimal concentration of SFP that will maintain iron balance within the target hemoglobin range.
Rockwell Medical Technologies, Inc. Announces Updated DSMB Interim Results; No Safety Issues Reported
Rockwell Medical Technologies, Inc. announced 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.
Rockwell Medical Technologies, Inc. Announces Patient Enrollment Begins For NIH Funded SFP Clinical Study
Rockwell Medical Technologies, Inc. announced that patient enrollment has started for a National Institutes of Health (NIH) sponsored clinical study for Soluble Ferric Pyrophosphate (SFP), the Company's physiological iron-maintenance-therapy drug.
Rockwell Medical Technologies, Inc. Announces FDA Approval To Start Of NIH Sponsored Study Of Iron Therapy Drug-DJ
Dow Jones reported that U.S. Food and Drug Administration has approved Rockwell Medical Technologies, Inc.'s initiation of a National Institutes of Health sponsored clinical study for its drug-delivery product SFP for hemodialysis patients.
Rockwell Medical Technologies, Inc. Closes $12.95 Million Financing-DJ
Dow Jones reported that Rockwell Medical Technologies, Inc. has raised $12.95 million in gross proceeds from a private placement of its common shares. The Company also announced that $12.7 million in proceeds will fund the remaining expenses related to the development of its iron maintenance therapy drug.
Rockwell Medical Technologies Q3 results
ROCKWELL MEDICAL TECHNOLOGIES INC : * Rockwell Medical Technologies reports third quarter results; sales increase 50 percent * Third quarter loss per share $0.04 * Third quarter sales $11.1 million
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