# US 7,612,071 B2 · Compositions and methods employing aminopterin

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- Number: US 7,612,071 B2
- Document ID: US7612071B2
- Status: Granted
- Kind: B2
- Application number: 11/078,614
- Filed: 2005-03-09
- Published: 2005-09-22
- Granted: 2009-11-03
- Earliest claimed: 2004-03-12
- Assignees: Syntrix Biosystems, Inc.
- Inventors: Barton Aron Kamen; Peter David Cole; Angela King Smith; John Anthony Zebala
- Web page: https://patentgrep.com/patent/US7612071B2

## CPC

- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61P 29/02: without antiinflammatory effect
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to pharmaceutical compositions containing the antifolate aminopterin, processes for making the compositions, and methods of using them to treat disorders in adult and pediatric patients. Pharmaceutical compositions substantially free of impurities are provided comprising a therapeutically effective amount of aminopterin, or a pharmaceutically acceptable salt thereof. Relative to the teachings of the prior art, the disclosed methods and compositions provide unexpected improvements that include a greater interpatient oral bioavailability in pediatric patients, a smaller interpatient coefficient of variation of oral bioavailability, a smaller mean intrapatient coefficient of variation of oral bioavailability, a greater therapeutic index, a smaller coefficient of variation of toxicity, efficacy in combination therapy, and efficacy of certain polyglutamated metabolites.

## Claims

### Claim 1

A method for treating a disorder in a patient, comprising administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of aminopterin, or a pharmaceutically acceptable salt thereof, wherein the disorder is refractory acute lymphoblastic leukemia.

### Claim 2 (depends on 1)

The method of claim 1, wherein a second drug is used in combination therapy and a second drug is an anti-neoplastic or anti-inflammatory drug.

### Claim 3 (depends on 1)

The method of claim 1, wherein the patient is a pediatric patient.