Tuesday, biopharmaceutical company Affymax, Inc. (AFFY) stated that data from middle stage clinical trial revealed no major impact of baseline renal function as measured by Estimated Glomerular Filtration Rate or eGFR on the monthly Hematide dose required to increase and maintain hemoglobin or Hgb values within target range in non-dialysis chronic kidney disease or CKD patients.
Hematide is a synthetic, peptidic erythropoiesis stimulating agent or ESA linked to polyethylene glycol or PEG that is being developed for the treatment of anemia associated with chronic renal failure.
The Palo Alto, California-based company said the data was from a post hoc analysis of 120 patients in a Phase 2 clinical trial of Hematide in non-dialysis CKD patients, presented by Dr. Iain Macdougall at the World Congress of Nephrology in Milan.
The post-hoc analysis included data from an open-label Phase 2 study of 120 patients with stage 3, 4 or 5 CKD. The analysis suggested that the mean Hgb increased approximately 2 g/dL by three months and remained stable for five months across all CKD groups, regardless of baseline eGFR. In addition, Hematide doses were similar across all CKD groups regardless of baseline eGFR. Twelve patients (10%) reported an adverse event considered possibly related to treatment. The company underlined that that study was not specifically designed to evaluate the effect of renal function on Hematide dose and therefore caution should be exercised in the interpretation of results.
Macdougall, consultant nephrologist in the Department of Renal Medicine at King's College Hospital in London said, "As Hematide is partially excreted by the kidneys, it was imperative to evaluate whether renal function affected the product's ability to achieve hemoglobin target ranges."
Macdougall noted that the data suggest that Hematide results in appropriate management of hemoglobin levels in a broad spectrum of patients with CKD, regardless of baseline renal function. He is of the view that anemia is a pervasive problem in the chronic kidney disease patient population and being able to manage and control anemia allows treating physicians to focus attention on management of the patient's underlying renal disease.
Affymax closed Tuesday's regular trading at $15.88, up $0.77 or 5.10%, on a volume of 16,798 shares on the Nasdaq.
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