Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Affymax has completed enrollment in the first of four Phase III clinical trials of its lead investigational therapy, Hematide, which is being evaluated for the treatment of anemia in chronic renal failure patients.
Subscribe to our email newsletter
Pearl 1 is fully enrolled with over 475 non-dialysis patients from over 70 sites in the US. The Hematide Phase III program, involving a total of approximately 2,400 chronic renal failure patients, consists of four open-label, randomized controlled clinical trials in the US and Europe, including two trials in patients on dialysis and two trials in patients not on dialysis.
The trials in non-dialysis patients, called Pearl 1 and Pearl 2, are evaluating the safety and efficacy of Hematide compared to darbepoetin alfa in correcting anemia and maintaining hemoglobin levels over time.
In dialysis patients, the trials, called Emerald 1 and Emerald 2, are evaluating the safety and efficacy of Hematide and its ability to maintain hemoglobin levels in a corrected range when patients are switched from epoetin alfa or epoetin beta to Hematide.
Anne-Marie Duliege, chief medical officer of Affymax, said: “The completion of enrollment in our first Phase III trial for Hematide is significant and moves us closer to our ultimate goal of providing a once-monthly treatment alternative for the many patients with anemia associated with chronic renal failure. We continue to target completion of enrollment in the other three Phase III trials in our pivotal program by year end 2008.”