• Affymax Inc., of Palo Alto, Calif., disclosed results to date from two separate Phase II trials with Hematide in dialysis and non-dialysis chronic kidney disease patients. The data showed that in treatment-naive, non-dialysis patients, Hematide could correct anemia when administered monthly at an appropriate dose. In dialysis patients previously treated with three-times weekly epoetin alfa (Epogen, Amgen Inc.), the drug demonstrated that mean hemoglobin levels could be maintained at clinically acceptable levels following a switch to once-monthly dosing of Hematide at an appropriate dose. Hematide is a synthetic, pegylated peptide that binds to and activates the erythropoietin receptor.

• Alimera Sciences Inc., of Atlanta, and pSivida Ltd., of Perth, Australia, said enrollment for their Phase III global clinical trial, the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) study has exceeded 50 percent. FAME is a double-masked, randomized, multicenter study that will follow about 900 patients in the U.S., Canada, Europe and India for 36 months. The trial is studying the safety and efficacy of Medidur for diabetic macular edema. Medidur, a tiny, injectable intravitreal insert, is being studied as a way to deliver a very low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years.

• Pharmion Corp., of Boulder, Colo., said the multi-center, open-label Phase I clinical trial of single dose oral azacitidine in patients with myelodysplastic syndromes, acute myeloid leukemia and malignant solid tumors has been successfully completed, and the company will be initiating the planned multidose Phase I trial. The first trial assessed the bioavailability and pharmacokinetics of escalating single doses of oral azacitidine, while taking a look at safety and tolerability. The next study is a multicenter, open-label dose-escalation trial and will assess the maximum tolerated dose, dose-limiting toxicities and safety of seven-day, multicycle dosing.

No Comments