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| Anemia | |
| Syntonix’ EPO-Fc Syntonix is developing an EPO-Fc fusion drug as potential treatment for anemia. Exploiting the body’s Fc receptor pathways, the drug has the potential to both extend half-life and possibly facilitate drug delivery alternatives to the currently used injections. Eliminating the need for repeated injections would be a substantial advantage in several treatment settings, notably for patients with chronic kidney disease who are not yet on dialysis or are treated with peritoneal dialysis. A Phase I proof-of-principle clinical study with one of these EPO-Fc drugs showed promising results. Syntonix is now preparing another EPO-Fc drug candidate with significantly enhanced pharmacokinetic parameters for clinical development About Anemia Anemia is the condition that results from a shortage of red blood cells. As a result, patients suffer chronic and often debilitating fatigue. Anemia, which is often under-recognized and under treated, is associated with many chronic diseases and other conditions. Normally, when individual red cell count falls, the consequent drop in oxygen carried in the blood stimulates the kidneys to product erythropoietin (EPO). In many situations – such as chronic kidney disease and cancer, hepatitis, and HIV patients treated with chemotherapy or radiation – the kidneys are either unable to produce EPO or the amount produced is inadequate to return the red cell count to normal. Since the early 1990’s EPO produced by recombinant DNA technology has been available to help patients suffering from anemia. EPO has a relatively short half-life and frequent injections are required to maintain active levels. More recently, extended half-life drugs to stimulate red cell production have been developed, reducing the required frequency of injections. Market Opportunity The National Center for Health Statistics estimated in 1996 that 3.4 million Americans were living with anemia. Over 290,000 Americans were on dialysis regimens in 2001, the last year for which statistics are available. Over 90% of these patients were treated with EPO. A somewhat higher number of chronic kidney disease patients had a serious loss of kidney function but did not yet require dialysis. 31% of these patients received EPO although at substantially smaller doses than dialysis patients. For both the dialysis and pre-dialysis populations, both EPO dosing and usage increased during the five years prior to 2001. In addition, almost 500,000 cancer patients suffer from anemia, with about one third treated with EPO, generally at substantially higher doses than for dialysis patients. In 2004, the worldwide market for EPO related drugs exceeded $10 billion. Extended half-life drugs are supplanting usage of short-acting first generation EPO, with worldwide sales for the extended half-life drugs forecast at $4.5 billion in 2008. More background information on anemia can be found at www.anemia.org. More information on the treatment of chronic kidney disease related anemia can be found at www.usrds.org |
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