Home         Forums  

Go Back   Marrowforums > Bone Marrow Failure Diseases > News and Events
Register FAQ Search Today's Posts Mark Forums Read

News and Events News related to bone marrow failure diseases

Reply
 
Thread Tools Search this Thread
  #1  
Old Fri May 16, 2008, 05:51 AM
Birgitta-A Birgitta-A is offline
Member
 
Join Date: Oct 2007
Location: Stockholm, Sweden
Posts: 1,918
Thumbs up Abstracts from 2008 ASCO available

Hi all,
Now abstracts from 2008 ASCO are available. I have copied an abstract about oral Vidaza .

http://www.abstract.asco.org/

"ASCO 2008 A phase I, open-label, dose-escalation study to evaluate the safety, pharmacokinetics, and pharmacodynamics of oral azacitidine in subjects with myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML)
J Clin Oncol 26: 2008 (May 20 suppl; abstr 7091)
B. S. Skikne, M. R. Ward, A. Nasser, L. Aukerman, G. Garcia-Manero

Background
Azacitidine (Vidaza), a cytidine analog, through its effects on DNA metabolism, gene expression, and cell differentiation, has proven beneficial in treatment of MDS and AML.

Most notably, prolonged azacitidine therapy recently has been shown to approximately double 2-year survival in higher-risk MDS subjects compared to conventional care. Azacitidine is currently approved for intermittent subcutaneous and intravenous administration.

Development of an oral formulation would provide more convenient dosing, eliminate injection-site reactions, and allow evaluation of novel, continuous low-dose regimens that may sustain demethylation and improve efficacy. A proprietary formulation of oral azacitidine was shown to be absorbed in a pilot, single-dose study (ASCO 2007).

Methods
This is a multicenter, open-label, Phase 1, sequential design, dose-escalation study of oral azacitidine. The study is designed to evaluate the maximum tolerated dose, dose limiting toxicities, safety, pharmacokinetic and pharmacodynamic profiles of increasing doses of orally administered azacitidine in subjects with MDS or AML.

Azacitidine was administered subcutaneous (75 mg/m2/day x 7 days) during cycle 1, then orally starting at 120 mg x 7 days/28 day cycle. Drug levels were measured in plasma and urine, and pharmacodynamic effects including global LINE methylation and gene-specific methylation were assayed.

Results
Currently, no toxicities have been observed in subjects who have completed both the subcutaneous and oral phases of the study at 120 mg. The study continues at the 180 mg dose level. Preliminary pharmacokinetic analysis indicates detectable plasma levels at the 120 mg oral dose.

A comparison of plasma pharmacokinetic profiles and pharmacodynamic effects of azacitidine administered at increasing oral doses compared to those of azacitidine administered subcutaneous at the approved dose of 75 mg/m2/day for all subjects evaluated to date will be presented.

Conclusions
Initial results of oral 5-azacitidine indicate that this formulation is orally bioavailable and safe in subjects with MDS."

Kind regards
Birgitta-A
Reply With Quote
Reply


Thread Tools Search this Thread
Search this Thread:

Advanced Search

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

vB code is On
Smilies are On
[IMG] code is On
HTML code is Off
Forum Jump

Similar Threads
Thread Thread Starter Forum Replies Last Post
ASH 2008 abstracts Birgitta-A News and Events 5 Wed Nov 12, 2008 05:18 PM
AA&MDSIF 2008 Patient & Family Conference Marrowforums News and Events 3 Fri Jul 25, 2008 11:28 PM
Aamac 2008 Summer News Letter Now Online Doug Mylie Canada 1 Mon Jul 14, 2008 01:55 PM
2008 March Madness Friends Fundraising Challenge Marrowforums News and Events 1 Thu May 1, 2008 04:10 PM
Registration Opens for AA&MDSIF 2008 Patient & Family Conference Marrowforums News and Events 0 Tue Apr 29, 2008 01:51 AM


All times are GMT -4. The time now is 01:23 PM.


Powered by vBulletin® Version 3.6.7
Copyright ©2000 - 2024, Jelsoft Enterprises Ltd.
Forum sites may contain non-authoritative and unverified information.
Medical decisions should be made in consultation with qualified medical professionals.
Site contents exclusive of member posts Copyright © 2006-2020 Marrowforums.org