Tiziana Life Sciences a cancer drugs making focused clinical stage biotechnology company got approval in Israel to start testing inhibitor of cell cycle dependent kinases (CDKs), milciclib in a phase II clinical trial.
This particular testing will be for patients with refractory hepatocellular carcinoma (HCC). Thte company noted that a similar clinical trial protocol has been submitted for approval in Italy, Turkey and Greece.
The company added that the primary goal of this testing will be to check the safety of milciclib in HCC patients who fail to respond or are intolerant to the existing standard of care treatment. First patient enrollment is expected next month and top line data from the trial is expected by Q3 2018, Tiziana said.
Gabriele Cerrone, Chairman of Tiziana noted that HCC is a real unmet medical need due to its growing incidence and lack of effective therapy. Cerrone pointed out that it is the fifth most common cancer worldwide and the second most common cause of death from cancer worldwide. “We strongly believe that milciclib has the potential to be developed either as a monotherapy or in combination with sorafenib for treatment of HCC,” Tiziana’s Chariman added.
Dr. Yaron Ilan, Chief Medical Officer of Tiziana explained that the prognosis for liver cancer is very poor due to lack of effective therapy. He said that recent pre-clinical findings are promising and the upcoming phase II clinical trial in HCC patients with milciclib in patients that failed to respond to the standard of care therapy will give a better picture. “We believe that milciclib holds promise as an effective anti-cancer treatment with a high safety profile,” Ilan concluded.