LONDON (Alliance News) - Biotechnology company Tiziana Life Sciences PLC said Wednesday that the phase 2a trial of Milciclib safety and tolerability in patients with Metastatic Hepatocellular Carcinoma has progressed well so far.
The trial is currently ongoing, being conducted in Greece, Italy and Israel with demonstration of good tolerability with acceptable incidence of serious adverse events making the milestone to initiate a phase 2b trial evaluating the combination of milcicib and sorafenib.
So far, major findings were that the treatment was well tolerated with manageable drug-related toxicities, and four patients have completed the study per protocol, with two opting to continue receiving treatment at full dose and a third awaiting ethical committee approval.
"We are pleased with the conclusion of IDMC that milciclib treatment showed no major signals of tolerability concerns in sorafenib-refractory or -intolerable HCC patients. These findings are consistent with the findings reported earlier on the long-term tolerability and clinical activity of milciclib in thymic carcinoma, thymoma1 and other solid cancers. Results from these clinical studies strongly warrant further clinical development of milciclib for treatments of HCC and other cancers," said Chief Executive Kunwar Shailubhai.
Shares in Tiziana Life Sciences were untraded on Wednesday, last quoted at 78.00 pence.