A Study of Aezea® (Cenersen) in Transfusion Dependent Anemia Associated With Myelodysplastic Syndrome (MDS)

Phase 1 Terminated 9 enrolled Eleos, Inc. H. Lee Moffitt Cancer Center and Research Institute · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to test the safety of six cycles of cenersen treatment and to begin to test the hypothesis that intermittent administration of cenersen may lead to a reduced dependence on transfusion.

Timeline

Start: 2014-09
Primary completion: 2015-09-30
Completion: 2015-12-31

Publications

Background Caceres G, McGraw K, Yip BH, Pellagatti A, Johnson J, Zhang L, Liu K, Zhang LM, Fulp WJ, Lee JH, Al Ali NH, Basiorka A, Smith LJ, Daugherty FJ, Littleton N, Wells RA, Sokol L, Wei S, Komrokji RS, Boultwood J, List AF. TP53 suppression promotes erythropoiesis in del(5q) MDS, suggesting a targeted therapeutic strategy in lenalidomide-resistant patients. Proc Natl Acad Sci U S A. 2013 Oct 1;110(40):16127-32. doi: 10.1073/pnas.1311055110. Epub 2013 Sep 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	cenersen	Antisense oligonucleotide	0.3 mg/kg	Intravenous
Comparator	cenersen	Antisense oligonucleotide	0.6 mg/kg	Intravenous
Comparator	cenersen	Antisense oligonucleotide	1.2 mg/kg	Intravenous
Comparator	Dexamethasone	Small molecule	20 mg	Oral

A Study of Aezea® (Cenersen) in Transfusion Dependent Anemia Associated With Myelodysplastic Syndrome (MDS)

Summary

Timeline

Publications

Drugs

Indications