StockMarketWire.com - Tiziana Life Sciences announced the development of a novel, proprietary, oral formulation of foralumab, a fully human anti-CD3 monoclonal antibody (mAb), to be used in upcoming clinical studies in patients with non-alcoholic steatohepatitis (NASH) and other inflammatory diseases. This is the first-ever development of an oral formulation suitable for therapy with foralumab (NI-0401). Tiziana Life Sciences Chairman Gabriele Cerrone said: "Oral immunotherapy with an anti-CD3 mAb is expected to be a preferred approach for targeted immunomodulation without eliciting immunosuppression throughout the body. "However until now, oral administration has not been pursued due to the expectation of mAbs being inactivated by the harsh conditions in the gastrointestinal tract. "The development of this proprietary oral formulation is a breakthrough in novel dosing formulation and we believe that this technology may have broad additional therapeutic utility with other mAbs." Tiziana CEO Kunwar Shailubhai commented: "Oral administration with biologics such as mAbs is a potential game changer for immunotherapies, enhancing drug safety while potentiating immunomodulation to provide clinical responses. "Recently we demonstrated, using humanized mice models, that orally administered foralumab is biologically effective to produce immunomodulatory activity. "Thus, successful development of the oral formulation of foralumab is a major milestone, and it opens up a novel avenue for treatment of NASH and other autoimmune diseases." Story provided by StockMarketWire.com