Maxy-G34; Pegylated Human GCSF

Specification

• Cat#: THP-0213
• Product Name: Maxy-G34; Pegylated Human GCSF
• Description: The product is a pegylated variant of human granulocyte-colony stimulating factor (G-CSF). This variant contains multiple non-naturally occurring lysines that have been introduced into alpha helixes of wild type human G-CSF as PEGylation sites, and from which multiple undesired, naturally occurring lysines have been removed as compared to wild type human G-CSF to avoid PEGylation of such sites. Specifically, the amino acid sequence of the product differs from that of human wild type G-CSF at residues 16, 34, 40, 105 and 159. This was accomplished by removing the three lysine residues at positions 16, 34 and 40, and replacing them with arginine, and substituting two new lysine residues at positions 105 and 159. The product is pegylated with 5 kd mPEG SPA (succinimidyl propionate) groups at 3 amino acid residues, including PEG groups attached at the amino terminal end of the protein and at two internal lysine residues, while Neulasta has a single 20 Kd PEG group attached at the N terminal end of the wild type G-CSF protein.
• Sequences: Not Available
• Species: Human
• Molecular Weight: Not Available
• Cas No: Not Available
• Formula: Not Available
• Endotoxin Level: <0.001 EU per 1 μg of the peptide by the LAL method

Pharmaceutical Information

• Pharmaceutical Application: Maxy-G34
• Applications: Investigated for use/treatment in adverse effects (chemotherapy) and neutropenics.
• Examples of Clinical Use: Adverse effects (chemotherapy) and neutropenics.
• Pharmacodynamics: The product is a PEGylated proprietary G-CSF variant designed to be administered as a single subcutaneous injection once per chemotherapy cycle. Maxygen has made changes in the G-CSF gene sequence that code for novel PEGylation sites in the resulting protein. In contrast to the currently marketed PEGylated G-CSF, the product has multiple PEG groups attached at specifically selected sites on the molecule. In several in vivo models, the product has demonstratedimproved pharmacokinetics and pharmacodynamics compared to the currently marketed PEGylated G-CSF.
• Mechanism of action: Neutropenia is a severe decrease in neutrophil cell counts in the blood. Neutropenia is a common side effect of chemotherapeutic treatments for many forms of cancer, including breast cancer, lung cancer, lymphomas and leukemias. Neutropenic patients contract bacterial infections more easily and often, some of which can be life threatening. Further, and most importantly, neutropenic patients may receive reduced or delayed chemotherapy treatment, which can result in cancer progression. Maxy-G34, like natural G-CSF is a protein that stimulates the body's bone marrow to produce neutrophils, a specific type of white blood cell that plays an important role in the defense against bacterial infections.
• Affected organisms: Humans and other mammals

Related Reading

1. Introduction of Maxy-G34 protein

Pegylated Human GCSF is a medication used to stimulate the bone marrow to produce more white blood cells, specifically neutrophils, which play an essential role in fighting infections. The "pegylated" part of the name refers to the addition of polyethylene glycol (PEG), which helps to prolong the drug's effects and reduce the required dosing frequency.

This medication is typically used in patients who have undergone chemotherapy or bone marrow transplants, as these treatments can result in decreased white blood cell counts and an increased risk of infection. Pegylated Human GCSF can help to speed up the recovery of the immune system, reducing the risk of serious infections.

It is important to note that this medication should only be used under the supervision of a healthcare professional and may not be suitable for everyone. Common side effects may include bone pain, headache, and fatigue. If you have any questions or concerns about Pegylated Human GCSF, please speak with your doctor.

2. Clinical application and mechanism of Maxy-G34 protein

Maxy-G34 (Pegylated Human GCSF) is a modified granulocyte colony-stimulating factor (G-CSF). It is modified by linking PEG groups to G-CSF molecules to enhance its biological activity, stability, and efficacy, and is a long-term, relatively stable substitute for G-CSF. Here is a brief overview of the clinical uses, mechanisms of action, and advantages and disadvantages of Maxy-G34.

2.1 Clinical application

Maxy-G34 is mainly used to promote leukocyte hyperplasia. In clinical use, it is often used to boost neutrophil numbers to prevent or treat infections caused by a decrease in white blood cells. Therefore, Maxy-G34 is widely used to treat diseases such as leukopenia syndrome after chemotherapy or bone marrow transplantation.

2.2 Action mechanism

Maxy-G34 increases the expression of cytokines that lead to cell proliferation by stimulating proliferation, differentiation, and functional activation of hematopoietic cells, especially neutrophils. By binding to the G-CSF receptor (G-CSFR), G-CSF regulates the expression of related genes in the nucleus, thereby promoting the proliferation and differentiation of neutrophils. Maxy-G34 is peG-enabled to achieve long-lasting in vivo effects, allowing it to be used in fewer times and doses, which is convenient for patients.

2.3 Advantages and disadvantages

The advantage of Maxy-G34 is that it can provide a durable, long-acting G-CSF effect, thereby increasing cell bioavailability, reducing the number of doses used, and reducing the financial and psychological burden on patients. It has good safety, low immunogenicity, and few adverse reactions in clinical application. The disadvantage is that it is expensive and not suitable for all patients. In addition, long-term use of Maxy-G34 may also lead to some side effects, such as excessive stimulation of the hematopoietic system caused by bone marrow hyperplasia, which needs to be closely monitored and evaluated.

In summary, Maxy-G34 is a modified granulocyte colony-stimulating factor that increases the expression of cytokines that lead to cell proliferation by regulating neutrophil proliferation, differentiation, and activation, thereby increasing the number of neutrophils for the treatment of infectious diseases caused by leukocytosis. Although Maxy-G34 has many advantages such as long-term, durable, and safe, it also comes with some shortcomings that need to be carefully considered by doctors and patients. Maxy-G34 (Pegylated Human GCSF) has entered clinical studies and is approved by the European Medicines Agency (EMA) for the prevention and treatment of neutrophilia due to chemotherapeutic myelopathic suppression. Maxy-G34 is currently undergoing several other clinical trials to explore its use in other indications.

3. Clinical research progress

Maxy-G34 is not currently approved by the FDA, but its manufacturer, Maxygen, has conducted a series of clinical trials in the United States to explore its safety and efficacy in other diseases. Maxygen is also working with other pharmaceutical companies to pursue additional new drug research and development for Maxy-G34.

In addition to Maxy-G34, several other peG-CSF formulations are also under development, such as Neulasta and Mozobil. These new and modified G-CSF formulations also have better stability and durability, further improving treatment outcomes and patients' quality of life.

In summary, Maxy-G34 is a pegylated modified G-CSF formulation that has been approved for the treatment of neutropenia in European Union countries. Although currently not approved by the FDA, Maxy-G34 still has a wide range of uses and development prospects. At the same time, related research and development are also continuing, and more excellent G-CSF formulations will emerge in the future to provide better treatment options for patients.