SymBio Pharmaceuticals commences a Phase 1 study in Japan for oral TREAKISYM in progressive solid tumors afflicted patients.
SymBio sought approval for TREAKISYM injectables exhibited in the treatment of malignant lymphoma. The aim of this study was to establish the fact that the new oral formulation can be developed thereby alleviating negative impacts, including alopecia, compared with existing chemo therapy. SymBio will assess dosage regimes with no adverse effect on the efficacy by leveraging the pharmacokinetic traits of the oral formulation, specifically, lessening Cmax and administration in lower doses regimes during the treatment period. Oral formulation drugs can also e taen at home, revoking the need for the patient to visit the hospital for intravenous infusion and alleviating the treatment burden on the patient.
The development of oral TREAKISYM is part of SymBio’s strategy to develop a “TREAKISYM platform.” For TREAKISYM injectables, the Phase III study for the indication of relapsed/refractory diffuse large B-cell lymphoma is underway. Although DLBCL accounts for the largest segment of malignant lymphoma in terms of patient numbers, currently only multiple drug therapies are available for r/r DLBCL.