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
