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VAL001 is a proprietary oral formulation of sodium valproate, a small molecule histone deacetylase (HDAC) inhibitor, developed by Respiratorius AB for the treatment of diffuse large B-cell lymphoma (DLBCL). It is specifically designed as a pre-treatment to be administered prior to standard R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). The drug acts as an epigenetic modulator that increases the expression of the CD20 surface protein on malignant B-cells, thereby enhancing the binding and therapeutic efficacy of rituximab and sensitizing tumor cells to the cytotoxic effects of chemotherapy. VAL001 has completed Phase I/IIa clinical trials demonstrating significantly improved survival rates compared to historical R-CHOP data and has received orphan drug designation in both the United States and Europe. The European Medicines Agency (EMA) has validated that the program can proceed directly into Phase III trials.
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