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Intratumorally administered lactoferrin in the treatment of malignantneoplasms and other hyperproliferative diseases

Inactive Publication Date: 2010-06-03
AGENNIX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0020]FIG. 5 shows squamous cell tumor growth with and without intratumoral administration of recombinant lactoferrin once or twice a day.

Problems solved by technology

Currently, there are few effective options for the treatment of many common cancer types.
However, if the cancer has metastasized and is widespread, surgery is unlikely to result in a cure, and an alternate approach must be taken.
Side effects of surgery include diminished structural or organ function and increased risk of infection, bleeding, or coagulation related complications.
The disadvantage of many of the alternative therapies are the side effects, which can include myelosuppression, skin irritation, difficulty swallowing, dry mouth, nausea, diarrhea, hair loss, weight loss, and loss of energy (Curran, 1998; Brizel, 1998).

Method used

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  • Intratumorally administered lactoferrin in the treatment of malignantneoplasms and other hyperproliferative diseases
  • Intratumorally administered lactoferrin in the treatment of malignantneoplasms and other hyperproliferative diseases
  • Intratumorally administered lactoferrin in the treatment of malignantneoplasms and other hyperproliferative diseases

Examples

Experimental program
Comparison scheme
Effect test

example 1

Inhibition of Tumor Growth by rhLF

[0088]Human squamous cell carcinoma (O12) was used. The cells were injected into the right flank of athymic nude mice. rhLF was administered either intratumorally (49 animals, 7 doses ranging from 0.05 μg to 125 μg per dose), intravenously (7 animals, 125 μg / dose) or orally (7 animals 20 mg / dose). Control animals were treated with only the vehicle; no rhLF was administered to the control animals. rhLF was administered twice a day for either five days (intravenous group) or eight days (all other groups) starting 11 days after inoculation with tumor cells to allow formation of established tumors.

[0089]The efficacy of treatment was evaluated by measuring the solid tumor size during and at the end of the experiment; the body weights were also determined at the time of tumor measurements. As seen in FIG. 1 and Table 1, treatment with rhLF reduced rates of tumor growth relative to the control by 46% to 80%. In fact, oral treatment with 20 mg rhLF most sig...

example 2

Evaluation of rhLF in Tumor Types

[0091]Tumor cells from a broad range of tumor types are injected into the right flank of athymic nude mice. Animals are administered either rhLF, native hLF or bovine LF orally. Control animals are treated with only the vehicle, no rhLF is administered to the control animals. rhLF is administered either once or twice a day for either one, five, seven or fourteen days or eight days starting approximately eleven days after inoculation with tumor cells to allow formation of established tumors or at such other time as is generally done with standard or published regimens.

[0092]The efficacy of treatment is evaluated by measuring the solid tumor size during and at the end of the experiment; the body weights are also determined at the time of tumor measurements. The immune response is measured by measuring the amount of cytokines, T-cells and NK cells in circulation and in the intestine.

example 3

Effect of Oral Administration of rhLF and bLF

[0093]Recombinant human lactoferrin and bovine lactoferrin were orally administered to mice, and the production of IL-18 in the small intestine was measured.

[0094]Mice were treated for three days daily with 65 mg / kg / day of rhLF, 300 mg / kg / day of rhLF or 300 mg / kg / day of bLF. For a control, mice were only administered the pharmaceutical carrier. Twenty-four hours following administration of the LF or control for 3 days, animals were weighed and blood and serum were collected. Serum was used for cytokine ELISA assays.

[0095]Also, at these time points, animals were sacrificed and the small intestinal tissue was removed for further analysis. Small intestinal epithelium was homogenized using a lysis buffer consisting of PBS, 1% Nonidet P-40, 0.5% sodium deoxycholate, and 0.1% sodium dodecyl sulphate containing 10 μg / ml PhenylMetheylsulfonyl fluoride. Homogenate was centrifuged at 15,000 rpm for 10 minutes and the supernatant stored at −80 C til...

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Abstract

The present invention relates to methods of treating a hyperproliferative disease by administering a composition of lactoferrin alone or in combination with standard anti-cancer therapies.

Description

[0001]This application is a continuation of U.S. application Ser. No. 10 / 435,319 filed May 9, 2003, which claims the benefit of U.S. Provisional Application No. 60 / 379,442 filed on May 10, 2002; U.S. Provisional Application No. 60 / 379,441 filed on May 10, 2002 and U.S. Provisional Application No. 60 / 379,474 filed on May 10, 2002, which are incorporated herein by reference in their entirety.FIELD OF INVENTION[0002]The present invention relates to methods of treating a hyperproliferative disease by administering a composition of lactoferrin alone or in combination with standard anti-cancer therapies. The lactoferrin composition may be administered orally, intravenously, intratumorally, or topically.BACKGROUND OF THE INVENTION[0003]Currently, there are few effective options for the treatment of many common cancer types. The course of treatment for a given individual depends on the diagnosis, the stage to which the disease has developed, and factors such as age, sex, and general health ...

Claims

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Application Information

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IPC IPC(8): A61K38/16A61P35/04A23L1/305A61K45/00A61K31/337A61K33/24A61K38/40A61P1/02A61P1/04A61P9/00A61P9/10A61P17/06A61P19/02A61P29/00A61P35/00A61P35/02A61P37/00A61P37/04A61P43/00
CPCA23L1/3056A23V2002/00A61K38/40A23V2250/54248A23L33/19A61P1/02A61P1/04A61P11/00A61P15/00A61P17/00A61P17/06A61P19/02A61P29/00A61P35/00A61P35/02A61P35/04A61P37/00A61P37/04A61P43/00A61P9/00A61P9/10
Inventor VARADHACHARY, ATULBARSKY, RICKPETRAK, KARELO'MALLEY, BERT
Owner AGENNIX
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