Japan-based SymBio Pharmaceuticals has started a Phase I clinical trial for the oral variant of its existing cytocide anti-cancer injectable TREAKISYM to treat progressive solid tumours.

TREAKISYM is made of the bendamustine hydrochloride compound and is currently available in more than 50 markets to treat low-grade non-Hodgkin’s and mantle cell lymphomas, and chronic lymphocytic leukaemia.

The Phase I trial will investigate the safety, tolerability, recommended dose and dosage regimen of oral TREAKISYM, and identify the types of solid tumours that can be potentially treated with this drug.

While the safety and efficacy of TREAKISYM injectables were validated in previous clinical studies, the latest trial aims to deliver a new therapy with superior traits and less adverse events compared to current chemotherapy.

“The latest trial aims to deliver a new therapy with superior traits and less adverse events compared to current chemotherapy.”

SymBio intends to leverage oral formulations’ pharmacokinetic features such as lower Cmax and doses to assess safer dosage regimes without any adverse effects.

Through the oral variant of its drug, the firm also expects to eliminate the need for hospital visits and treatment burden on patients.

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The firm plans to further maximise the value of the anti-cancer drug by extending its product-life with the development of TREAKISYM ready-to-dilute and Rapid Infusion liquid formulations under its sustainable growth strategy.

TREAKISYM injectables were originally approved in 2010 for the treatment of relapsed/refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma, then for chronic lymphocytic leukaemia in 2016.

Currently, the injectables are being evaluated in a Phase III trial for relapsed/refractory diffuse large B-cell lymphoma.