Tiziana completes patient enrolment in ongoing Milciclib study

3rd Dec 2018 14:27

(Sharecast News) - Biotechnology company Tiziana Life Sciences announced on Monday that patient enrolment in its ongoing Phase 2a clinical trial, known as CDKO-125A-010, was now completed.The AIM-traded firm said it was a single-arm, repeated-dose, six-month duration study to evaluate the safety, tolerability and anti-tumor activity of 'Milciclib' in Sorafenib-refractory or -intolerant patients with unresectable or metastatic hepatocellular carcinoma (HCC).It said topline data from the multi-centre trial, being conducted in Italy, Greece and Israel, would be available in the second quarter of 2019."Previously we reported interim analysis data from the first 10 patients, following six months of treatment, showing that Milciclib at 100 mg once daily; four days on and three days off every four weeks ... was well-tolerated in this HCC patient population," the Tiziana board said in its statement."It was concluded by an Independent Data Monitoring Committee (IDMC) that there were no major signals of tolerability concerns, and the IDMC allowed continuation of patient enrollment in the trial."Following completion of six months of treatment, three patients opted to continue treatment under the compassionate use program."Tiziana Life Sciences said that notably, one patient was still continuing treatment in the 14th month, with the other two patients received treatment until the ninth month and 13th month, respectively.