IP Library Granted Patent US 10,543,259
Granted Patent B2
US 10,543,259 · App. 15/015,410 · Granted Jan 28, 2020

Methods and compositions for the identification and treatment of individuals having or likely to develop short stature

Inventors: Andrew Nahum Dauber (Amberley, OH); Vivian Hwa (Cincinnati, OH)
Assignee: Children's Hospital Medical Center
A61K38/4886A61K9/0019C12Q1/6883A61K48/00C12Q2600/106C12Q2600/156C12Y304/24
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Quick Facts
Patent No.
US 10,543,259
App. No.
15/015,410
Granted
Jan 28, 2020
Kind
B2
Abstract

The instant disclosure relates to methods useful for the treatment or prevention of progressive growth failure in a subject in need thereof. The method may include the step of administering a PAPPA2 gene product to the subject. Also disclosed is the identification of a novel gene mutation that may be used as a marker to identify subjects particularly suited for such treatment. Compositions containing a therapeutically effective amount of PAPPA2 protein and a pharmaceutically acceptable carrier are also disclosed.

Claims (10)

1. A method of treating progressive growth failure in a human subject diagnosed with idiopathic short stature and having a mutation in PAPP-A2, comprising administering plasma containing a PAPP-A2 enzyme intravenously to said human subject;

wherein said PAPP-A2 mutation is a homozygous loss-of-function mutation selected from D643fs25*, Ala1033Val, or a combination thereof;

wherein said mutation causes elevated serum levels of total IGF-I in said subject;

wherein said PAPP-A2 enzyme administered to said subject does not contain said homozygous loss-of-function mutation selected from D643fs25*, Ala1033Val, or a combination thereof; and

wherein said administration increases free IGF1 (fIGF1) in said subject.

2. The method of claim 1 , wherein said human subject is identified as small for gestational age without catch up growth.

3. The method of claim 1 , wherein said subject is administered said plasma during puberty, prior to puberty, or both.

4. The method of claim 1 , where said human subject has a height of about two standard deviations below the mid-parental target height.

5. The method of claim 1 , comprising co-administering a growth hormone to said subject.

6. The method of claim 5 , wherein said growth hormone is co-administered at a time period selected from one or both of simultaneously and sequentially.

Assignments (2)
CONFIRMATORY LICENSE Recorded Dec 1, 2016
From: CINCINNATI CHILDRENS HOSP MED CTR
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 040787/0563 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 3, 2016
From: DAUBER, ANDREW NAHUM; HWA, VIVIAN
To: CHILDREN'S HOSPITAL MEDICAL CENTER
Reel/Frame 037885/0914 →
Continuity (2)
Provisional Application 62126831 · Mar 2, 2015
Related Publication 20160256530A1 · Sep 8, 2016