Method for treating neutropenia caused by chemotherapy or radiotherapy
A technology for neutropenia, applied in extracellular fluid diseases, pharmaceutical formulations, organic active ingredients, etc.
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[0022] As generally described herein, the present disclosure provides methods for increasing absolute neutrophil count, granulocyte number, stem cell production, hematopoiesis, hematopoietic progenitor cell number, or stem cell production in a donor in a subject eligible for bone marrow transplantation, or with A method of treating or preventing a disorder characterized by impaired leukocyte production in a patient in need thereof, comprising administering an effective amount of Eflapegrastim within a period of less than 24 hours after administering to the patient a chemotherapeutic agent or receiving radiotherapy.
[0023] definition
[0024] To facilitate understanding of the present invention, a number of terms and phrases are defined below.
[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Abbreviations used herein have their co...
Embodiment 1
[0118] Example 1: Preparation of Eflapegrastim ( 17,65 S-G-CSF-PEG-Fc)
[0119] Step 1: Preparation of Immunoglobulin Fc Fragments Using Immunoglobulins
[0120] Preparation of the immunoglobulin Fc fragment was prepared as follows.
[0121] 200 mg of 150-kDa immunoglobulin G (IgG) (Green Cross) dissolved in 10 mM phosphate buffer was treated with 2 mg of proteolytic enzyme and papain (Sigma) at 37°C with gentle agitation. ), Korea) 2 hours.
[0122] After the enzymatic reaction, the immunoglobulin Fc fragment thus regenerated was purified by chromatography using a Superdex column, a protein A column and a cation exchange column in this order. In detail, the reaction solution was loaded on a Superdex 200 column (Pharmacia) equilibrated with 10 mM sodium phosphate buffer (PBS, pH 7.3), and the column was eluted with the same buffer at a flow rate of 1 ml / min. Unreacted immunoglobulin molecules (IgG) and F(ab')2, which have relatively high molecular weights compared to imm...
Embodiment 2
[0129] Example 2: Efficacy study of different dosing regimens of Eflapegrastim in rats with docetaxel / cyclophosphamide-induced neutropenia
[0130] Eflapegrastim (HM10460A), a long-acting G-CSF analog, was compared with filgrastim by different dosing regimens in a rat model with chemotherapy-induced neutropenia.
[0131] In the following studies, Eflapegrastim was prepared essentially as described in Example 1.
[0132] (i) Research materials
[0133] 【Table 1】
[0134] testing sample
[0135]
[0136] 【Table 2】
[0137] carrier
[0138] name composition state of preservation supplier Dulbecco's Phosphate Buffered Saline () - 2°C to 8°C Sigma-Aldrich
[0139] 【table 3】
[0140] Neutropenia inducers
[0141]
[0142] Preparation of HM10460A regimen for subcutaneous administration
[0143]Preparation of 61.8 μg / kg HM10460A solution for subcutaneous administration: Dilute a stock solution of HM10460A (6.0 mg / mL) 92.7 μL with DPBS 1790...
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