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

Konference: 2007 49th ASH Annual Meeting - účast ČR

Kategorie: Maligní lymfomy a leukémie

Téma: Postery

Číslo abstraktu: 3666

Autoři: Lisa M. Pickering, MBBS, BA, MRCP; MUDr. Karel Cwiertka, Ph.D.; prof. dr hab. n. med. Jacek Jassem; prof. MUDr. Jiří Petera, Ph.D.; Ruth Pettengel, MBchB, FRACP, PhD; Ramlau Rodryg; prof. MUDr. Jiří Vorlíček, CSc., dr.h.c.; prof. MUDr. Rostislav Vyzula, CSc.; Anne-Marie Duliege; Lang William; B. Stead Richard; G. Harper Peter

Introduction: Hematide a novel, synthetic, PEGylated peptidic compound, binds to and activates the erythropoietin receptor. It is in development for treatment of anemia associated with chronic renal failure and cancer. Objective: To assess the subcutaneous (SC) Hematide dose required to increase hemoglobin (Hb) by 1 g/dL in 50% of anemic cancer patients (pts) on chemotherapy. Safety, pharmacodynamics and pharmacokinetics were also assessed. Method: In a phase 2, open label, multi-center, dose finding study, up to four doses of Hematide were given SC every 3 wks (Q3W) to 4 cohorts of fifteen pts at 0.05, 0.10, 0.15 or 0.2 mg/kg each. Entry criteria included confirmed solid tumor malignancy or lymphoma, >9 weeks of chemotherapy, baseline (BL) H 8 and <11 g/dL, and adequate iron, folate and B12 stores. Results: Sixty patients were enrolled (45% male). Preliminary data show that across cohorts 0.05, 0.10, 0.15 and 0.20 mg/kg, mean (BL) Hb values were 10.1(1.07), 10.0(0.89), 9.8(0.67), 10.1(0.69); the % of pts completing the study were approximately 79%, 50%, 60%, and 92%. An increase in mean Hb from BL of 1g/dL in the pharmacodynamic dataset (forty two pts) at Week 7 occurred in approximately 20%, 70%, 55% and 55% of patients. Three pts withdrew due to AEs and six due to SAEs (none attributed to study drug). Three deaths occurred (two disease progression, one renal insufficiency) none attributed to study drug. One SAE, thrombophlebitis, was considered to be possibly/probably related to study drug. Final safety and efficacy data will be provided at the meeting. Conclusion: In this study, HematideTM dosed SC Q3W resulted in an increase from BL of 1 g/dL of Hgb in 50% of patients in the 0.10, 0.15 and 0.20 mg/kg cohorts in the pharmacodynamic analysis. HematideTM appeared to be well tolerated at all doses studied.

Abstract #3666 appears in Blood, Volume 110, issue 11, November 16, 2007

Keywords: Chemotherapy-Induced Anemia|Erythropoietin Receptor|Chronic Renal Failure

Disclosure: Employment: W. Lang, AM Duliege,are employees of Affymax Inc, the company developing this investigational compound. Consultancy: R. Stead is a consultant to Affymax Inc. Ownership Interests:; W.Lang, AM. Duliege and R. Stead have stock options in Affymax Inc. Research Funding: All authors other than those listed above are investigators in the study and receive financial compensation for the conduct of the trial. Honoraria Information: R. Stead receives honoraria from Affymax inc. as a consultant to this company. Membership Information: R. Stead is a member of Affymax Inc. advisory committee.

Monday, December 10, 2007 5:00 PM

Session Info: Poster Session: Red Cell Regulation and Disorders of Production (5:00 p.m.-7:00 p.m.)

Datum přednesení příspěvku: 10. 12. 2007