US 9,239,333 B2Granted

Methods of determining efficacy of treatment in a subject having heart failure

AssigneeCritical Care Diagnostics, Inc.

InventorJames V. Snider

Life of this patent

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Abstract

Provided are methods for evaluating the risk of an adverse clinical outcome in a subject, deciding whether to discharge or continue treating a subject (e.g., treatment on an inpatient basis), or to initiate or terminate treatment, selecting a subject for participation in a clinical study, and selecting a therapeutic treatment for a subject that include determining a level of ST2 in a biological sample from the subject and determining a level of galectin-3 in a biological sample from the subject. Kits are also provided that contain an antibody that specifically binds to ST2, an antibody that specifically binds to galectin-3, and instructions for using the kit to evaluate the risk of an adverse clinical outcome in a subject, to decide whether to discharge or continue treating a subject (e.g., treatment on an inpatient basis) or to initiate or terminate treatment, to select a subject for participation in a clinical study, and/or to select treatment for a subject.

Claims18

Dependent claims

A method for determining the efficacy of a treatment a subject having heart failure, the method comprising:

(a) performing an assay to determine a level of galectin-3 in a biological sample from a subject having heart failure;
(b) comparing the level of galectin-3 in the biological sample of (a) to a reference level of galectin-3;
(c) selecting a subject having an elevated level of galectin-3 in the biological sample of (a) as compared to the reference level of galectin-3;
(d) performing an assay to determine a level of soluble ST2 in a biological sample obtained from the selected subject at a first time point before administration of a treatment;
(e) performing an assay to determine a level of soluble ST2 in a biological sample obtained from the selected subject at a second time point after administration of the treatment and after the first time point;
and
(f) determining that the treatment was effective in a selected subject having a decrease in the level of soluble ST2 in the biological sample of (e) as compared to the level of soluble ST2 in the biological sample of (d).

4 more elements

Dependencies are inferred from the claim text.

Facts

Application: 14/267,487Filed 1 May 2014 · continuation
Priority: 17 Mar 2011
Published: US 2014/0234875 A121 Aug 2014
Granted: 19 Jan 2016
Term ends: Not estimatedThe source records don’t support an estimate.

Classification19 codes

G01N 33/6893
Involving proteins, peptides or amino acids: related to diseases not provided for elsewhere
A61P 9/00
Drugs for disorders of the cardiovascular system
G01N 33/53
Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing:…
G01N 33/68
Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing:…

Family

Application61/453,782Us provisional application · filed 17 Mar 2011
Application13/422,574Parent of this continuation · filed 16 Mar 2012
US 2014/0234875 A1Pre-grant publication · published 21 Aug 2014
US 8,728,742 B2Parent of this continuation
US 2012/0276551 A1Published application
US 9,239,333 B2This patent

From the US filing history. Foreign family members aren’t listed.