Co-administration of a polysaccharide with a chemotherapeutic agent for the treatment of cancer

a polysaccharide and cancer technology, applied in the field of cancer treatment, can solve the problems of the efficacy of a particular dosage to target and kill tumor cells, and the toxic effect of a particular dosage, so as to improve the tolerance of the patient to the agent, and improve the effect of the therapeutic

Inactive Publication Date: 2005-03-10
PRO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0025] Enhanced therapeutic efficacy means that the therapeutic index of chemotherapeutic agent (alone or as a composition comprising one or more polysaccharides and one or more therapeutic agents) exceeds the desired physiological effect, such as tumor size reduction, tumor growth delay, etc., compared to that of a reference chemotherapeutic agent, and / or improving a patient's tolerance for the agent.

Problems solved by technology

Unfortunately, chemotherapeutic agents have significant limitations relating to their toxic effect on the patient and the efficacy of a particular dosage to target and kill tumor cells.
Although these agents are effective for treating cancer cells that generally grow rapidly through unregulated cell division, they also kill healthy non-cancerous cells as they undergo ordinary cell division.
This toxic effect is particularly apparent in fast-growing normal cells, such as bone marrow cells, those in the digestive tract, hair follicles, and reproductive cells.
Because chemotherapy harms healthy tissue, the effectiveness of a drug is limited by its dosage levels and treatment frequency such that it should not exceed the tolerance levels for non-cancerous cells.
Moreover, the chemotherapy regimen often dramatically diminishes the quality of a patient's life through its physical and emotional side effects.
Without the ability to target the drug exclusively to cancerous tissue, chemotherapy dosages must be kept within a range (i.e., the therapeutic index) that healthy tissue can tolerate, thus often reducing the optimal effectiveness of chemotherapy on diseased tissue.
Despite the advances that have been made in chemotherapeutic regimens, there remains a significant unmet medical need for increasing the efficacy of chemotherapeutic agents while at the same time reducing their toxicity.

Method used

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  • Co-administration of a polysaccharide with a chemotherapeutic agent for the treatment of cancer
  • Co-administration of a polysaccharide with a chemotherapeutic agent for the treatment of cancer
  • Co-administration of a polysaccharide with a chemotherapeutic agent for the treatment of cancer

Examples

Experimental program
Comparison scheme
Effect test

example 1

Structure of Galactomannan

[0114] The galactomannan oligomer of the present invention is a polysaccharide. In one aspect it has an average molecular weight of about 48,000 D. Shown below is the acceptable chemical nomenclature and structural formula for the galactomann of the present invention. Also shown is the stereochemical configuration.

[0115] Full chemical name: (((1,4)-linked β-D-mannopyranose)17-((1,6)-linked-β-D-galactopyranose) 10) 12).

[0116] A backbone composed of linear (1→4)-β-D-Mannopyranosyl units, to which single β-D-Galactopyranosyl is attached by (1→6) linkage as illustrated below:

[0117]FIG. 2 shows the structure of the galactomannan polysaccharide of the present invention as determined by Nuclear Magnetic Resonance (NMR). The galactomannan of the present invention was compared to galactomannan from Carob (locust bean) gum. An easy identification of the two principal sugar residues, that is mannose (Man) and galactose (Gal), comes from two peaks, at 4.8 p.p.m. (...

example 2

[0134] Purification and Manufacturing Process

[0135] Shown in FIG. 5 is a flow chart of an example for a purification and manufacturing process for a galactomannan of the present invention. High grade Guar gum is dissolved in warm water at 1% at 45° C. for 2 hr. The pH is reduced to 2.2 with 1 M HCl and solution is heated to 95° C. for ˜2 hours. Then pH is adjust to 5.8 with 1 M NaOH. The solution is then cool to 20° C. and filter with glass filter. Next CuSO4 / Na-K tartrate is added and the precipitate is collected on 200 mesh filter, wash with water solution and than washed in 5% HCl in 96% EtOH. Than washed with 75% EtOH and twice with 96% EtOH. And finally vacuum freeze-dried as white solids. Galactomannan, from a readily available source (e.g., Guar gum), was selected for process optimization and manufacturing. The soluble galactomannan oligomer was tested in-vivo (in animals) for both efficacy and overall reduction of toxicity.

[0136] The manufacturing process described above p...

examples 3-5

[0138] Efficacy Studies

[0139] The galactomannan of the present invention is a galactomannan derivative comprising exposed galactose moieties attached to a mannose backbone. The compound is thought to interact with galactose-binding lectins or galectins that are generally located on cell surfaces. Lectins are carbohydrate-binding proteins, typically located on the cell surface, which mediate various types of cellular interactions. It is generally accepted that lectins mediate many biological recognition events in plants and in animal tissues, and in tumor cell lines. Lectins play a role in cell-cell adhesion, and in the organization of the extracellular matrix. At the cell surface, lectins can act as receptors involved in selective intercellular adhesion and cell migration, recognition of circulating glycoproteins, and modulation of cell-cell and cell-matrix interactions. Galectins are members of a family of β-galactoside-binding lectins with related amino acid sequences. Galectins ...

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Abstract

Disclosed herein are compositions and methods for treating diseases such as cancer. The compositions comprise one or more polysaccharides in an admixture with one or more therapeutic agents. This admixture can be administered to a subject in need thereof using any known method of administration. The therapeutic agent, if administered alone, can cause undesirable side-effects in the subject. The polysaccharide component minimizes or eliminates these side effects. The compositions described herein effectuate an enhanced therapeutic effect along with reduced toxicity.

Description

FIELD OF THE INVENTION [0001] The present invention relates to compositions and methods for treating disease. Specifically, the instant invention relates to compositions comprising a polysaccharide and pharmaceutical agent, wherein the polysaccharide lowers the toxicity profile of the drug as well as increase its efficacy. BACKGROUND OF THE INVENTION [0002] The most widely used methods to treat cancer are surgery, radiation and chemotherapy. Cancer patients often receive a combination of these treatments and about half of all patients receive chemotherapy. Unfortunately, chemotherapeutic agents have significant limitations relating to their toxic effect on the patient and the efficacy of a particular dosage to target and kill tumor cells. [0003] Most chemotherapeutic agents kill cancer cells once they begin to undergo division and replication. Cells are killed by disrupting cell division. For example, a chemotherapeutic agent may prevent the formation of new DNA or block some other ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K31/4965A61K31/519A61K33/243A61K38/20A61K38/21A61K45/06A61K47/36
CPCA61K9/0019A61K31/4965A61K31/519A61K33/24A61K38/2013A61K38/208A61K38/212A61K45/06A61K47/36A61K2300/00A61P35/00A61P35/04A61P43/00A61K33/243
Inventor ZOMER, ELIEZERPLATT, DAVID
Owner PRO PHARMA
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