Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05764928
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-02-17
Brief Title:
Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed Cisplatin Therapy
Sponsor:
Rgene Corporation
Organization:
Rgene Corporation
Study Overview
Official Title:
A Phase III Open Label Study to Evaluate the Safety and Efficacy of BLEX 404Oral Liquid Combined With Pemetrexed Cisplatin Therapy in Patients With Advanced Inoperable or Metastatic EGFR Wild-type Non-Small Cell Lung Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Maitake is reported with immunomodulatory functions against tumor growth in terms of its unique molecular structure β-glucan polysaccharides within 1 6 main chain having 1 3 branches and a 1 3 main chain having 1 6 branches configuration The β-glucan is identified as a main component of BLEX 404 Not only with therapeutic potential on several types of cancer BLEX 404 has also shown the potential to improve hematopoiesis granulocyte colony stimulating factor G-CSF production and the cytotoxicity activity of immune cells in recent animal studies Its antitumor effect on tumor-bearing mice is exerted by enhancing the immune system through activation of macrophages T cells and natural killer NK cells
The activation of antigen presenting cells APCs such as macrophages dendritic cells DCs via BLEX 404 administration is in response to secretion of interleukin-12 IL-12 BLEX 404 has been found to enhance the activity of immunocompetent cells such as helper T cells cytotoxic T cells and NK cells either by ip injection or oral intake therefore it stimulates innate and adaptive immunity BLEX 404 enhances hematopoiesis by increasing mouse bone marrow cell and human cord blood cell differentiation into granulocytes-macrophages GMs granulopoiesis and mobilization of granulocytes and granulocyte macrophage colony-stimulating factor GM-CSF or G-CSF production One related phase I healthy human trial by treating with Maitake D-fraction was examined in Italy The published data of trial for solid tumor patients was in the year 2003 in Japan and another for breast cancer patients was in the year 2009 in the United States executed by Memorial Sloan Kettering Cancer Center MSKCC Lately same team amended IND for myelodysplastic syndromes MDS human trial All those human experiences are the fundamental of developing BLEX 404 Oral Liquid
The activation of antigen presenting cells APCs such as macrophages dendritic cells DCs via BLEX 404 administration is in response to secretion of interleukin-12 IL-12 BLEX 404 has been found to enhance the activity of immunocompetent cells such as helper T cells cytotoxic T cells and NK cells either by ip injection or oral intake therefore it stimulates innate and adaptive immunity BLEX 404 enhances hematopoiesis by increasing mouse bone marrow cell and human cord blood cell differentiation into granulocytes-macrophages GMs granulopoiesis and mobilization of granulocytes and granulocyte macrophage colony-stimulating factor GM-CSF or G-CSF production One related phase I healthy human trial by treating with Maitake D-fraction was examined in Italy The published data of trial for solid tumor patients was in the year 2003 in Japan and another for breast cancer patients was in the year 2009 in the United States executed by Memorial Sloan Kettering Cancer Center MSKCC Lately same team amended IND for myelodysplastic syndromes MDS human trial All those human experiences are the fundamental of developing BLEX 404 Oral Liquid
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None