Phase 2 study data of ALD518 demonstrates reversal of anemia in NSCLC patients

Dec 9 2010

Alder Biopharmaceuticals Inc. today announced that data from a Phase 2 study of its ALD518 investigational antibody therapeutic that targets interleukin-6 (IL-6) demonstrate a reversal of anemia in patients with advanced non-small cell lung cancer (NSCLC).

After 12 weeks of treatment with the anti-inflammatory therapeutic, 58 percent of patients who received ALD518 experienced hemoglobin level increases from less than 11 g/dL to more than 12 g/dL, while no patients receiving placebo experienced this increase. In addition, patients who received ALD518 had an average lean body mass loss of 0.19 kg, compared to an average loss of 1.5 kg in those who received placebo. Additional symptoms of the disease such as fatigue were also reduced in patients who received ALD518.

The data was presented by Michael Schuster, M.D., director of the hematologic malignancy program at Stony Brook University Medical Center, at the annual meeting of the American Society of Hematology. The presentation, titled "Inhibition of Interleukin-6 (IL-6) Reverses Anemia In Patients with Advanced Non-Small Cell Lung Cancer (NSCLC): Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial," took place on Monday, December 6.

"The anemia of chronic disease that is seen in cancer patients is in large part due to IL-6 stimulation of hepcidin, resulting in reduced plasma iron levels," said Dr. Schuster. "Given the recent safety concerns over the use of ESAs, alternative therapeutic approaches that target IL-6, such as ALD518, would be very desirable and could potentially reduce the requirement for transfusions in this patient population."

Randall Schatzman, Ph.D., president and chief executive officer of Alder Biopharmaceuticals, added, "We continue to be encouraged by strong clinical data from ALD518 in the areas of cancer, cancer supportive care and cancer anemia. We look forward to continuing our clinical investigation in these areas in the coming year."

SOURCE Alder Biopharmaceuticals Inc.