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Application of monoclonal antibody in treating esophageal cancer

A monoclonal antibody, esophageal cancer technology, applied in the direction of antibodies, anti-tumor drugs, drug combinations, etc., can solve problems such as poor efficacy of esophageal cancer

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

Esophageal cancer remains poorly treated despite significant advances in treatment techniques such as surgery, radiotherapy, and chemotherapy

Method used

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  • Application of monoclonal antibody in treating esophageal cancer
  • Application of monoclonal antibody in treating esophageal cancer
  • Application of monoclonal antibody in treating esophageal cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1. Pre-clinical pharmacodynamic test

[0035] 1. In vitro activity

[0036] Nimotuzumab and H-125 human lung adenocarcinoma tumor cell line, A431 human vaginal epithelial cancer tumor cell line, and MDA-MB-468 human breast cancer tumor cell line were tested by the balanced binding test of 99mTc labeled Nimotuzumab The ability of monoclonal antibodies to bind to tumor cells. Labeled using a freeze-drying kit (purchased from Sigma-Aldrich (Shanghai) Trading Co., Ltd.) at room temperature. After 15 minutes, an average of (97.38±0.23)% of 99mTc was labeled on the IgG antibody. Fast paper chromatography of the monoclonal antibody in acetone showed that about 3% or less of free pertechnetic acid ran to the front of the reagent (Rf=10). This reveals that almost all pertechnetic acid has been reduced. The colloidal morphology of Nimotuzumab measured by the ITLC method impregnated with 1.0% albumin was (1.68±0.81)%. The maximum binding (Bmax) of 99mTc-labeled nimotuzumab ...

Embodiment 2

[0055] Example 2. Safety evaluation of clinical anti-tumor:

[0056] One observes the tolerability and efficacy of radiotherapy combined with nimotuzumab combined with radiotherapy in the treatment of esophageal cancer. A total of 42 patients with stage II esophageal cancer (squamous cell carcinoma) who were inoperable or refused surgery in stage II and only metastasized to the supraclavicular lymph nodes received conformal radiotherapy (DT50-70Gy), and were given 200 mg nitoplasty weekly at the same time Belizumab treatment. In 37 patients, Taixinsheng used more than 5 times (88.1%). It was found that 1-2 grade toxic side effects (21.4%) mainly included 1 case of digestive tract reaction, 3 cases of esophagitis, 4 cases of skin reaction, and 1 case of bone marrow suppression. Fever occurred in 9 patients, 5 cases of grade 1 lung injury, 3 cases of lung infection, 2 cases of fatigue, other paresthesias, sepsis, herpes zoster, increased bilirubin, heart discomfort, and esophagot...

Embodiment 3

[0058] Example 3. Toxicity test

[0059] 1. Acute Toxicology Research

[0060] The toxicity test of single-dose injection was performed on Sprague Dawley rats in accordance with the requirements of GLP standards. The doses are respectively 0, 0.25, 1.25 and 5 times the highest human dose of 400 mg (5.71 / mg / Kg). Each of the four groups of animals has 5 female and 5 male rats. Except for the increase in the number of soft stools in all animals (p<0.05), there were no deaths and clinical abnormalities in the administration and the control group. Conclusion: No obvious toxicity characteristics were found in any dose of the injection.

[0061] 2. Subacute toxicity study

[0062] A subacute study of repeated doses of nimotuzumab was done on animals (two rat trials and one monkey trial) with a dose of 4.0 to 12.7 times the highest human dose per kilogram (315mg / dose or 4.5mg / Kg). ), the monoclonal antibody is produced from the main cell bank and the expanded cell bank. The products prod...

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Abstract

Relating to the field of medicines, the invention specifically relates to application of a monoclonal antibody resisting an epidermal growth factor receptor (EGFR) in treating esophageal cancer, especially a humanized monoclonal antibody, nimotuzumab. The monoclonal antibody is a specifically purified antibody generated for specific antigens. With high specificity, the monoclonal antibody can be used for targeted therapy specifically to tumor cells, and can reverse malignant biological behaviors of tumor cells at a molecular level. Characterized by strong targeting, high specificity and low toxic as well as side effect, etc., the monoclonal antibody provided in the invention can substantially strengthen the curative effects of radiotherapy and chemotherapy.

Description

Technical field [0001] The invention relates to the use of an anti-epidermal growth factor receptor monoclonal antibody in the treatment of esophageal cancer. Background technique [0002] According to the World Health Organization report, there are currently about 10 million new cancer patients worldwide and nearly 6 million deaths each year. Since the 1970s, the incidence and mortality of malignant tumors in my country have been on the rise. In 2010, the total number of cancer incidences was approximately 2 million, and the deaths were 1.5 million. At present, the death rate of tumors has surpassed that of cardiovascular and cerebrovascular diseases and has become the first. Malignant tumors have become the "first killer" of mankind. [0003] Globally, there are about 462,000 new cases of esophageal cancer each year, the incidence rate ranks 8th among malignant tumors, and the mortality rate ranks 6th. The disease has an obvious regional distribution. my country is a country w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P35/00
Inventor 白先宏罗兰多赵快乐王绿化梁军马国胜马博晨郑隽奇李桂珠吕慧王海龙
Owner BIOTECH PHARMA CO LTD
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