US4859452A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Methods for the reduction of difluoromethylornithine associated toxicity
Assignee: The University of Texas System
•
Filing: 1987-01-13
•
Granted: 1989-08-22
•
Expires: 2007-01-13
Abstract
Abstract Disclosed are total parenteral nutrition formulations which include essential amino acids in combination with either arginine or ornithine, for use in the detection of recurrent malignant disease in patients. Such formulations stimulate tumor-specific polyamine production to a greater extent than non-tumor related polyamine production. Additionally, such formulations were found to specifically promote an increase in red blood cell putrescine levels of tumor-bearing rats. Nontumor-bearing rats were not found to be similarly reactive to these formulations. Methods for making and administering these formulations as well as their use in preventing DFMO-induced toxicity are also disclosed.
Inventors
- 👤 Jaffer Ajani
- 👤 Bruce Grossie, Jr.
- 👤 Kenji Nishioka
- 👤 David M. Ota
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-26 06:15
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/01
Claims Analysis
Total Claims: 11
Claim 1
Independent Claim
80 words
A method for reducing difluoromethylornithine associated toxicity in a patient comprising administering to a patient in need thereof a parenteral formulation comprising from about 0.05 about 2.0 grams per 100 ml. of at least one essential amino acid selected from the group consisting of leucine, isoleucine, valine, phenylalanine, lysine, histidine, threonine, and tryptophan; in combination with from about 50 to about 750 mg per 100 ml. of a polyamine precursor selected from the group consisting of methionine, arginine, and ornithine.
Claim 2
Independent Claim
80 words
A method for reducing difluoromethylornithine associated toxicity in a patient comprising administering to a patient in need thereof a parenteral formulation comprising from about 0.05 about 2.0 grams per 100 ml. of at least one essential amino acid selected from the group consisting of leucine, isoleucine, valine, phenylalanine, lysine, histidine, threonine, and tryptophan; in combination with from about 50 to about 750 mg per 100 ml. of a polyamine precursor selected from the group consisting of methionine, arginine, and ornithine.
Claim 3
Dependent Claim
81 words
The method of claim 1, wherein the pharmacologically acceptable amount of the selected essential amino acid comprises the following weight range of the amino acid for every 100 milliliters of the formulation: 250 to 1400 mg of leucine; 200 to 1400 mg of isoleucine; 200 to 1250 mg of valine; 100 to 900 mg of phenylalanine; 150 to 750 mg of lysine; 85 to 500 mg of histidine; 100 to 550 mg of threonine; and 50 to 200 mg of tryptophan.
Claim 4
Independent Claim
39 words
A method for reducing difluoromethylornithine associated toxicity in a patient comprising administering to patient in need thereof a parenteral formulation comprising a therapeutically effective amount of a polyamine precursor selected from the group consisting of methionine, arginine, and ornithine.
Claim 5
Independent Claim
39 words
A method for reducing difluoromethylornithine associated toxicity in a patient comprising administering to patient in need thereof a parenteral formulation comprising a therapeutically effective amount of a polyamine precursor selected from the group consisting of methionine, arginine, and ornithine.
Claim 6
Dependent Claim
19 words
The method of claim 3 wherein the formulation further comprises a total parenteral nutrition solution comprising essential amino acids.
Claim 7
Dependent Claim
27 words
The method of claim 3 wherein the therapeutically effective amount of the polyamine precursor is between 50 and 750 mg for every 100 milliliters of the formulation.
Claim 8
Dependent Claim
14 words
The method of claim 1 or 3 wherein the selected polyamine precursor is methionine.
Claim 9
Dependent Claim
14 words
The method of claim 1 or 3 wherein the selected polyamine precursor is ornithine.
Claim 10
Dependent Claim
20 words
The method of claim 7 wherein the ornithine is present in the formulation at a concentration of approximately 33 mM.
Claim 11
Dependent Claim
14 words
The method of claim 1 or 3 wherein the selected polyamine precursor is aginine.
References Cited (Backward Citations)
US3235597A
Cited
US3236601A
Cited
US3764703A
Cited
US3832465A
Cited
US3950529A
Cited
US4065552A
Cited
US4444890A
Cited
US4542750A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1992-08-21 | 1993-02-20 | 1993-08-22 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-08-21 | 1997-02-20 | 1997-08-22 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-08-21 | 2001-02-20 | 2001-08-22 | $7700.00 | Window Closed / Lapsed |