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news.Affymax, a biopharmaceutical company, has announced positive results from a long-term safety and effectiveness study of its lead investigational therapy, Hematide, which is being evaluated for the treatment of anemia in chronic renal failure patients.
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In the Phase II study, 182 patients using Hematide once every four weeks for up to 23 months successfully maintained average hemoglobin levels within an 11 to 12g/dl target range.
A retrospective analysis of 115 patients from a Phase II study showed that Hematide also maintains average hemoglobin levels within target in dialysis patients regardless of gender, age, race or diabetes as cause of chronic kidney disease. Because this study was not designed to evaluate efficacy in each demographic subgroup, no formal conclusions can be drawn from this analysis, the company said.
Although the Hematide Phase II studies did not include a comparator group, to date, results indicate that the safety profile of Hematide appears to be comparable to currently approved erythropoiesis stimulating agents(ESA).
In the Hematide Phase III study program, which is already underway with the first patients dosed in the fourth quarter of 2007, safety and effectiveness as co-primary endpoints will be compared directly to darbepoetin alfa in the pre-dialysis setting and epoetin alfa or epoetin beta for patients on dialysis.
Iain Macdougall, senior lecturer at King’s College Hospital in London, said: “If the ongoing Phase III trials yield similar results as the Phase II data and if approved for marketing, Hematide could potentially provide healthcare professionals and patients with a differentiated alternative to current ESA therapies available in the US.”