Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed + Cisplatin Therapy
Status:
Not yet recruiting
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
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 i.p 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.