Effect of Granulocyte-macrophage Stimulating Factor on Prevention and Treatment of Invasive Fungal Diseases in the Recipients of Allogeneic Stem Cell Transplantation: A Prospective Multicenter Randomized Phase 4 Trial

We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.

Start Date01 Sep 2009

Sponsor / Collaborator

Xiamen Amoytop Biotech Co. Ltd.

[+1]

100 Clinical Results associated with Molgramostim biosimilar(Xiamen Amoytop Biotech Co. Ltd.)

100 Translational Medicine associated with Molgramostim biosimilar(Xiamen Amoytop Biotech Co. Ltd.)

100 Patents (Medical) associated with Molgramostim biosimilar(Xiamen Amoytop Biotech Co. Ltd.)

Literatures (Medical) associated with Molgramostim biosimilar(Xiamen Amoytop Biotech Co. Ltd.)

01 Apr 2022·Applied Microbiology and BiotechnologyQ3 · ENGINEERING & TECHNOLOGY

The pre-induction temperature affects recombinant HuGM-CSF aggregation in thermoinducible Escherichia coli

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Sánchez-Puig, Nuria ; Valdez-Cruz, Norma A ; Restrepo-Pineda, Sara ; Trujillo-Roldán, Mauricio A ; García-Hernández, Enrique ; Pérez, Néstor O

The overproduction of recombinant proteins in Escherichia coli leads to insoluble aggregates of proteins called inclusion bodies (IBs). IBs are considered dynamic entities that harbor high percentages of the recombinant protein, which can be found in different conformational states. The production conditions influence the properties of IBs and recombinant protein recovery and solubilization. The E. coli growth in thermoinduced systems is generally carried out at 30 °C and then recombinant protein production at 42 °C. Since the heat shock response in E. coli is triggered above 34 °C, the synthesis of heat shock proteins can modify the yields of the recombinant protein and the structural quality of IBs. The objective of this work was to evaluate the effect of different pre-induction temperatures (30 and 34 °C) on the growth of E. coli W3110 producing the human granulocyte-macrophage colony-stimulating factor (rHuGM-CSF) and on the IBs structure in a λpL/pR-cI857 thermoinducible system. The recombinant E. coli cultures growing at 34 °C showed a ~ 69% increase in the specific growth rate compared to cultures grown at 30 °C. The amount of rHuGM-CSF in IBs was significantly higher in cultures grown at 34 °C. Main folding chaperones (DnaK and GroEL) were associated with IBs and their co-chaperones (DnaJ and GroES) with the soluble protein fraction. Finally, IBs from cultures that grew at 34 °C had a lower content of amyloid-like structure and were more sensitive to proteolytic degradation than IBs obtained from cultures at 30 °C. Our study presents evidence that increasing the pre-induction temperature in a thermoinduced system allows obtaining higher recombinant protein and reducing amyloid contents of the IBs. KEY POINTS: • Pre-induction temperature determines inclusion bodies architecture • In pre-induction (above 34 °C), the heat shock response increases recombinant protein production • Inclusion bodies at higher pre-induction temperature show a lower amyloid content.

01 Oct 2010·Wounds : a compendium of clinical research and practiceQ4 · MEDICINE

Wound Healing: Experience With rHuGM-CSF.

Q4 · MEDICINE

Article

Author: Imbesi, R ; Ventimiglia, P ; Castrogiovanni, P

Skin wounds are exposed to a series of events that culminate in healing. This process is well known in relation to histological events, although mechanisms that underlie its regulation remain unclear, since not only are tissue growth factors involved, but also a number of cytokines. The present study focuses on treatment of chronic ulcers of lower limbs of two patients with recombinant human GM-CSF (rHuGM-CSF); the results were encouraging. Colony granulocyte/macrophage stimulating factor (GM-CSF) could be included between compounds promoting healing, in relation to direct or indirect effects of topical GM-CSF administration. Further study will be needed to determine dosage, method of application, and the type of recombinant material that will achieve the best results .

01 Aug 2010·CytokineQ3 · MEDICINE

Protective effects of recombinant human granulocyte macrophage colony stimulating factor on H1N1 influenza virus-induced pneumonia in mice

Q3 · MEDICINE

Article

Author: Dianwen Ju ; Hai Huang ; Pei Zhou ; Hong Li

Protective effects of recombinant human granulocyte macrophage colony stimulating factor (rHuGM-CSF) on H1N1 influenza virus infection was studied in vivo and in vitro. Mice were infected with H1N1 influenza A viruses and rHuGM-CSF at doses of 0.34, 0.67, and 1.34mgkg(-1)d(-1) was administrated for 7days before the mice were infected with influenza virus and continued for a further 3days. Compared with control mice, rHuGM-CSF was demonstrated to increase the survival rate of the infected mice by 50.0%, 55.6%, and 80.0% and increased the mean survival days by 25.7%, 30.0%, and 46.8%, respectively. Histopathological study of the lungs in pneumonia mice found that pre-treatment with rHuGM-CSF significantly ameliorated lung injury induced by influenza virus infection. In vitro study demonstrated that when rHuGM-CSF were co-incubated with peripheral blood mononuclear cells (PBMCs), the PBMCs culture supernatant induced a dose-dependent reduction of virus-induced cytopathic effect (CPE) in Madin-Darby canine kidney (MDCK) cells in vitro. These results suggested that rHuGM-CSF might be an effective and potential protection for H1N1 influenza virus-induced pneumonia.

100 Deals associated with Molgramostim biosimilar(Xiamen Amoytop Biotech Co. Ltd.)

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-	-	L03AA03	DB12525

R&D Status

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Indication	Country/Location	Organization	Date
Myelodysplastic Syndromes	CN	Xiamen Amoytop Biotech Co. Ltd.	31 Dec 1997
Neutropenia	CN	Xiamen Amoytop Biotech Co. Ltd.	31 Dec 1997

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CSCO2021	Not Applicable	-	-	SBRT+GM-CSF特尔立	liwrkyowkm(lffbzucofc) = epimnazugw jkndemdson (esnoknojkg )	-	25 Sep 2021
NCT01232504 (CTgov)	Phase 4	Invasive Fungal Infections	206	rhGM-CSF group (rhGM-CSF Group)	kfhmxncyuh(nsdpajgsfq) = ifutkrgzhm ghrukfdqnr (vxpsudsgpl, yhimqywdqe - qyzjkyhmqf) View more	-	27 Oct 2014
NCT01232504 (CTgov)	Phase 4	Invasive Fungal Infections	206	rhG-CSF group (rhG-CSF Group)	kfhmxncyuh(nsdpajgsfq) = azjtcntlky ghrukfdqnr (vxpsudsgpl, iccuhhtnii - nkdqnpcqeh) View more	-	27 Oct 2014

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