Erythropoiesis News and Research

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Keryx announces positive top-line results from Zerenex Phase 3 study for hyperphosphatemia

Keryx Biopharmaceuticals, Inc. today announced positive top-line results from the Phase 3 short-term efficacy study component of its Phase 3 registration program of Zerenex (ferric citrate), the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis.

30 Nov 2010

FG-2216 drug offers new treatment option for kidney disease-related anemia

A new drug called FG-2216 can stimulate production of the hormone erythropoietin (EPO) in dialysis patients—possibly offering a new approach to treatment of kidney disease-related anemia, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN).

30 Nov 2010

Vertex submits NDA for telaprevir for treating hepatitis C

Vertex Pharmaceuticals Incorporated announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C.

23 Nov 2010

FibroGen to present FG-4592 phase 2a study of patients with stage 3-4 Chronic Kidney Disease and anemia

FibroGen, Inc., today announced that new data from a phase 2a study of patients with stage 3-4 Chronic Kidney Disease and anemia will be presented demonstrating that its first-in-class, investigational oral anemia therapy FG-4592 works differently than erythropoiesis stimulating agents (ESAs) to increase hemoglobin.

19 Nov 2010

Bolder BioTechnology receives $1.2 million in Qualifying Therapeutic Discovery Project Grants

Bolder BioTechnology, Inc. today announced that it has been awarded a total of $1.2 million in Qualifying Therapeutic Discovery Project Grants. Grants were awarded for qualified investments under the Qualifying Therapeutic Discovery Project Tax Credit Program, which authorized up to $1 billion in tax credits or grants to biopharmaceutical companies with 250 or fewer employees.

4 Nov 2010

New guideline for using ESAs drugs in cancer patients

An updated joint guideline by the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO) advises physicians about the appropriate use of erythropoiesis-stimulating agents (ESAs), a class of drugs that stimulate the bone marrow to produce more red blood cells, to treat cancer patients with chemotherapy-induced anemia.

27 Oct 2010

Amgen reports $3,816 million for 2010 third quarter revenue

Amgen reported revenue unchanged for the third quarter of 2010 at $3,816 million versus $3,812 million for the third quarter of 2009.

26 Oct 2010

Amgen to review study results of ESA in chronic renal failure patients with FDA and CRDAC

Amgen will review the results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy) and will discuss how these results inform the appropriate use of erythropoiesis-stimulating agents (ESAs) for chronic renal failure (CRF) patients at today's meeting of the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC).

19 Oct 2010

Weight-based taribavirin reduces anemia, increases sustained virologic response

Researchers at Cedars-Sinai Medical Center and 50 other centers found that weight-based dosing of taribavirin reduces rates of anemia while increasing sustained virologic response (SVR) in patients with chronic hepatitis C (HCV). Full details of this study are available in the October issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

23 Sep 2010

FG-4592 oral anemia therapy receives CTA approval from SFDA

FibroGen, Inc., today announced that its investigational oral anemia therapy, FG-4592, received Clinical Trial Application (CTA) approval from the Chinese State Food and Drug Administration (SFDA) to commence clinical development for the treatment of anemia associated with chronic kidney disease (CKD) in the People's Republic of China.

21 Sep 2010

Phase 3 REALIZE study shows milestone in treatment development for hepatitis C

Vertex Pharmaceuticals Incorporated today announced that 65% of people overall achieved a sustained viral response (SVR or viral cure) with a telaprevir-based regimen in the pivotal Phase 3 REALIZE study, as compared to 17% of people in the control arm who received pegylated-interferon and ribavirin alone.

8 Sep 2010

Research finds link between chronic heart failure, iron deficiency

Iron plays a key role in human homeostasis. It is essential for growth and survival, and is a vital ingredient in numerous processes including erythropoiesis, oxygen transport and storage, oxidative metabolism in the skeletal and heart muscle, synthesis and degradation of lipids, carbohydrates, DNA and RNA. Important though it is, iron metabolism must be precisely controlled because iron is insoluble and excess levels can be toxic.

2 Sep 2010

Hemoglobin variability does not increase mortality in European hemodialysis patients: Study

Fluctuations in blood composition that often arise from commonly used therapies among kidney disease patients are not an independent predictor of adverse outcomes for European hemodialysis patients, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology. The results suggest that although hemoglobin variability is common in kidney disease patients, it does not appear to increase their likelihood of dying early.

27 Aug 2010

miRagen Therapeutics develop MicroRNA based therapeutics for cardiovascular and muscle disease

miRagen Therapeutics, Inc., a biopharmaceutical company focused on improving patients' lives by developing innovative microRNA-based therapeutics for cardiovascular and muscle disease, announced today the publication of data demonstrating the essential role of microRNA-451 (miR-451) in the regulation of erythropoiesis, the process of red blood cell production in the body.

3 Aug 2010

ArmaGen uses BBB molecular Trojan horse platform technology to create brain penetrating form of human EPO

Human erythropoietin (EPO) is a potent neuroprotective agent for multiple brain disorders, including stroke, brain and spinal cord injury, and Parkinson's disease. However, EPO drug development for the brain is limited, because EPO does not cross the blood-brain barrier (BBB). In acute stroke or brain injury, the BBB is intact in the early hours after the insult when neuroprotection is still possible. Therefore, large molecule biopharmaceuticals such as EPO must be re-engineered to enable BBB transport.

17 Jul 2010

New research reports evaluating nephrology market in Europe released

BioTrends Research Group, Inc. has released two new syndicated market research reports evaluating the nephrology market in Europe. The reports, TreatmentTrends: Renal Anemia and TreatmentTrends: Bone and Mineral Metabolism, are derived from the responses of over 200 European nephrologists polled in May and June, 2010 regarding their approach to managing renal anemia and bone and mineral disturbances in their dialysis and chronic kidney disease patients.

16 Jul 2010

Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that Phase IIb data for its lead drug candidate Soluble Ferric Pyrophosphate (SFP) have been accepted for presentation at the XLVII European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress, organized in collaboration with the Deutsche Gesellschaft fur Nephrologie (DGfN) in Munich, Germany, June 25-28, 2010.

25 May 2010

Data from Phase 2 clinical trials of Hematide/peginesatide presented at NKF Annual Meeting

Affymax, Inc. and Takeda Global Research & Development Center, Inc., U.S., today announced data from several post hoc analyses of Phase 2 clinical trials that evaluated Hematide/peginesatide in dialysis patients with anemia in chronic kidney disease. The data provide hypotheses for further investigation of this agent in anemia management in this patient population.

16 Apr 2010

Greater use of ESAs and iron at lower hematocrit levels decrease risk of death for hemodialysis patients

Greater use of erythropoiesis-stimulating agents (ESAs) and more frequent use of iron at lower hematocrit levels (the proportion of the blood that consists of red blood cells) was associated with a decreased risk of death for hemodialysis patients, according to a study in the March 3 issue of JAMA.

3 Mar 2010

Aggressive treatment of anemia with ESAs may lower risk of death for dialysis patients: Study

Aggressive treatment of anemia with intravenous iron and drugs known as erythropoiesis-stimulating agents (ESAs) may lower the risk of death for dialysis patients with severe anemia - but also may increase the risk of death among patients with milder anemia, a new study led by a University of North Carolina at Chapel Hill epidemiologist suggests.