RMTI- Rockwell medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.
There are approx 430,000 patients with End Stage Renal Disease (ESRD) being treated with dialysis dialysis in the U.S., and estimated 2.2 million ESRD patients worldwide, who require treatment for anemia. Anemia is a common occurrence in patients with ESRD due to the fact that the kidneys have become damaged and no longer produce and vital hormone called Erythropoietin.
Currently patients with renal failure are treated with erythropoiesis-stimulating agents (ESA's) for anemia, primarily used in dialysis patients, most of whom have treatments MWF or TTHSAT. ESA's are used in conjunction with IV Iron Dextran to keep the patients hemoglobin levels elevated but can put them at risk for stroke or MI if their hemoglobin goes in the excess of 11g/dl (grams per deciliter). For normal healthy males the level is 14-18 g/dl, females 11-16 g/dl. The current standard of treatment is Erythropoietin (EPO), a synthetic form of the hormone that is produced mainly by the kidneys (before they were damaged). EPO shots are given quite frequently and it can take a month or two before a significant enough rise in hemoglobin/hematocrit levels (> 5%) for the patient to start feeling any better.
When patients are administered ESA's during their dialysis visits it increases the bodies demand for iron, as it as precursor in the production of Red Blood Cells (RBC's). Also, the process of dialysis reduces the amount of iron in the blood stream. To treat the low levels of iron in the blood stream, patients are given Intravascular (IV) Iron at the same time ESA's are given to start the production of RBC's. Since the levels of Iron are deficient, the clinicians have to administer higher doses of ESA's and this process is repeated several times throughout the month until Hemaglobin/Hematocrit levels increase and can sometime take several months.
Unfortunately, this repeated use of giving ESA's along with IV Iron supplements can cause the body to react in an unfavorable manner for the patient. The bodies reticuloendothelial system isolates the IV iron in the liver and releases a chemical called hepcidin, which blocks the release of the iron that is bound to the liver. This buildup of iron in the liver is not a benign event, it can lead to toxicity and not to mention leads to hypoxia (decreased oxygen being delivered) to organs, tissues, and cells; due to the decreased production of RBC's. When the patient returns to the dialysis center, labs are redrawn, pt is given more ESA's along with IV Iron supplements and the cycle continues until liver toxicity occurs, pt becomes hypoxic at the cellular level or if its the one day a week that the doctor actually shows up to the dialysis center to check up on the patient.
The severe danger is that at some point the body reaches its breaking point and with excess amount of ESA's on board it starts increasing the production of RBC's leading to a high hemaglobin level, far in the excess of the safe range. This leads to strokes, Heart attacks, Pulmonary Embolism, Deep vein thrombosis, etc.
RMTI is currently working on developing and marketing Soluble Ferric Pyrophosphate (SFP). SFP is the company's lead investigational product, currently approaching the end of its Phase III trial (CRUISE 1 & 2), with results of CRUISE 1 expected in July and CRUISE 2 in October. SFP is an iron delivery therapy, designed to replace the current method of iron delivery to dialysis patients.
Here is an excerpt from the companies website:
"SFP has been designed to effectively address the current challenges in anemia management by:
- Maintaining hemoglobin (Hgb) levels within a safe range using moderate ESA doses
- Improving response to ESA therapy, while avoiding excessively high doses and potential risks
- Preventing iron from being stored in the liver thereby avoiding liver toxicity
- Reducing current drug administration costs