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Application of monoclonal antibody for treating colorectal cancer

A monoclonal antibody, colorectal cancer technology, applied in the direction of antibodies, anti-tumor drugs, drug combinations, etc.

Inactive Publication Date: 2012-05-09
BIOTECH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this system, it is precisely because of the overexpression of EGFR that leads to the proliferation and differentiation of tumor cells.

Method used

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  • Application of monoclonal antibody for treating colorectal cancer
  • Application of monoclonal antibody for treating colorectal cancer
  • Application of monoclonal antibody for treating colorectal cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1, preclinical pharmacodynamics study

[0036] 1. In vitro activity

[0037] Nimotuzumab was determined by an equilibrium binding assay between 99mTc-labeled Nimotuzumab and the H-125 human lung adenocarcinoma tumor cell line, the A431 human vaginal epithelial carcinoma tumor cell line, and the MDA-MB-468 human breast cancer tumor cell line Ability of mAbs to bind tumor cells. After labeling with a freeze-drying kit (purchased from Sigma-Aldrich (Shanghai) Trading Co., Ltd.) at room temperature for 15 minutes, an average of (97.38±0.23)% of 99mTc was labeled on the IgG antibody. Fast paper chromatography of mAb in acetone showed that approximately 3% or less of free pertechnetic acid ran to the reagent front (Rf = 10). This revealed that almost all of the pertechnetic acid was reduced. The colloidal form of Nimotuzumab was (1.68±0.81)% as determined by the ITLC method impregnated with 1.0% albumin. The maximum binding (Bmax) of 99mTc-labeled nimotuzumab c...

Embodiment 2

[0057] Embodiment 2, safety test

[0058] The safety trial study of colorectal cancer was divided into 3 dose groups (200, 400, 600 mg), 8 patients in each group, 24 cases in total. To evaluate the tolerability of nimotuzumab combined with chemotherapy in advanced colorectal cancer. Treatment with nimotuzumab combined with irinotecan. The completion of the treatment cycle evaluates the disease control rate, objective response rate, overall survival, quality of life QoL and safety of nimotuzumab combined with chemotherapy in the treatment of advanced colorectal cancer to investigate nimotuzumab as a potential treatment drug for advanced colorectal cancer security. A total of 24 patients, 13 males and 11 females. The mean age was 59.33 years old (35 to 74 years old), all of them were advanced epithelial cancers. 24 patients were divided into 3 treatment groups, 8 people in each group. The doses of each group are as follows: Group 1=200mg: 8 patients; Group 2=400mg: 8 patien...

Embodiment 3

[0059] Embodiment 3, toxicity test

[0060] 1. Acute Toxicology Study

[0061] The toxicity test of single dose injection was carried out on Sprague Dawley rats in accordance with the requirements of GLP standard. The doses are 0, 0.25, 1.25 and 5 times of the highest human dose of 400 mg (5.71 / mg / Kg), respectively. Each of the four groups of animals consisted of 5 female and 5 male rats. There were no deaths and no clinical abnormalities in the treated and control groups except for an increase in the number of soft stools in all animals (p<0.05). Conclusion: No obvious toxic reaction characteristics were found in injection of any dose of the drug.

[0062] 2. Subacute Toxicity Study

[0063] Repeated-dose subacute studies of nimotuzumab were performed on animals (two rat experiments and one monkey experiment) using doses that reached 4.0 to 12.7 times the highest human dose per kilogram (315 mg / dose or 4.5 mg / Kg). ), the mAb was produced from the main cell bank and the e...

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Abstract

The invention relates to the medicinal field, and more specifically relates to an application of a monoclonal antibody of an anti-epidermal growth factor receptor in the aspect of treating colorectal cancer, in particular to a humanized monoclonal antibody-nimotuzumab. The monoclonal antibody is a specific purified antibody generated aiming at a specific antigen, has high specificity, can specifically carry out targeted therapy aiming at tumor cells, can reverse the malignant biological behavior of the tumor cells at the molecular level, has the characteristics of strong targeting property, high specificity, low toxic side effect and the like, and can obviously enhance the therapeutic effects of radiotherapy and chemotherapy.

Description

technical field [0001] The invention relates to the use of a monoclonal antibody against epidermal growth factor receptor in the treatment of colorectal cancer. Background technique [0002] According to the report of the World Health Organization, there are about 10 million new cancer patients and 6 million deaths in the world every year. Since the 1970s, the incidence and mortality of malignant tumors in my country have been on the rise. In 2010, there were about 2 million cancer cases and 1.5 million deaths. At present, the death rate of cancer has surpassed that of cardiovascular and cerebrovascular diseases and has leapt to the first place. Malignant tumors have become the "first killer" of human beings. [0003] Recently, there are nearly 1.2 million new cases of colorectal cancer worldwide each year, and nearly 630,000 deaths, an increase of 27% and 28% compared with 2000, and an average annual increase of 3.9% and 4%. Colorectal cancer is the third most common can...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P35/00
Inventor 白先宏罗兰多沈琳秦叔逵马国胜马博晨郑隽奇李桂珠董晓敏金艳燕
Owner BIOTECH PHARMA CO LTD
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