HematideTM, a Synthetic Peptide-Based Erythropoiesis Stimulating Agent (ESA), Assessed for Correction of Anemia in Oncology Patients Receiving Chemotherapy.

Introduction: Hematide^TM, a novel synthetic PEGylated peptidic compound, binds to and activates the erythropoietin receptor. It is being developed for the treatment of anemia associated with chronic kidney disease and cancer.

Objective: To assess the subcutaneous (SC) Hematide^TM dose required to increase hemoglobin (Hgb) by ≥1g/dL in anemic cancer patients on chemotherapy. Safety, PD and PK assessment of Hematide^TM are also planned.

Method: In an ongoing phase 2, openlabel, multicenter, dosefinding study, Hematide^TM is being given SC in 15 patient cohorts every 3 wks for 4 doses. The initial dose is 0.10 mg/kg. Entry criteria include confirmed solid tumor malignancy or lymphoma, ≥9 weeks of chemotherapy, baseline (BL) Hgb 8 and <11 g/dL, and adequate iron, folate, and B12 stores.

Results: Preliminary results are presented for the 1st cohort. Mean body weight for the 8 female and 7 male patients was 67.8Kg. Nine out of 15 patients completed 12 weeks follow-up. Six patients terminated early for non-study drug related SAEs (2), remission of cancer (1), or transfusions (3, Hgb values posttransfusion excluded from this report) . Week 7: 10 patients completed Week (Wk) 7 with data available. Their mean SD Hgb increased from BL by 1.6±1.8 g/dL. Seven had a ≥1.0 g/dL Hgb increase (range 1.7-3.7 g/dL) at Wk 7. Of the remaining 3 patients, 2 had a Hgb increase of 1.65 and 1.1 g/dL, respectively at Wk 9; the 3rd had a Hgb increase of 1.7 g/dL at Wk 12. One patient with missing Wk 7 data had Hgb increases of 1.8 and 3.4 g/dL at Wk 6 and 9 respectively. Week 9: 11 patients had Wk 9 data that show a mean ±SD Hgb increase from baseline of 2.2±1.79 g/dL. Of these, 10 had Hgb increases of 1.0 g/dL (range 1.1-5.2 g/dL). The one patient who did not have 1.0 g/dL Hgb increase at Wk 9 had a Hgb increase of 1.7 g/dL at Wk 12. Four SAEs (none related to study drug) were reported in 3 patients.

Conclusion: Preliminary data from the 1st cohort indicate that Hematide^TM given every 3 wks appears to be well tolerated and results in an increase in Hgb of 1g/dL by Wk 7 in the majority of this study population. Additional data will be presented as it becomes available.