Update (19/07/2017): Tiziana has enrolled its first patient with refractory hepatocellular carcinoma in the Phase IIa trial with milciblib. Results are expected in the fourth quarter of 2018. 


Originally published on 24/04/2017

Tiziana Life Sciences has received approval to start Phase II in Israel with its leading compound, a CDK inhibitor targeting one of the deadliest cancers. 

Tiziana Life Sciences is an ambitious biotech in London targeting some of the most challenging autoimmune and inflammatory diseases, from type 1 diabetes to rheumatoid arthritis. The company just announced the approval of a Phase IIa trial to test its lead candidate, milciclib, as a treatment for hepatocellular carcinoma (HCC). The trial will run in Israel, Italy, Turkey, and Greece.

Milciclib is an inhibitor of several cyclin-dependent kinases (CDKs), which are commonly overexpressed in tumors resistant to chemotherapy. Accordingly, the investigational therapy will be tested in patients who have failed to respond to the standard of care treatment.

-tiziana life sciences hepatocellular carcinoma HCC milciclib

HCC is the second most common cause of death from cancer worldwide and commonly results from hepatitis infections or nonalcoholic steatohepatitis (NASH). There is currently no treatment for NASH, but biotech is racing to launch the first one one.

CDK inhibitors are not a new concept in the treatment of cancer. Pfizer’s Ibrance (palbociclib) and Novartis’ Kisqali (ribociclib) are CDK4/6 inhibitors that have already received approval in the treatment of breast cancer. In contrast, Tiziana’s milciclib is going after HCC and has a wider range of targets, CDK1, 4, 5 and 7.

However, its mechanism of action is not fully understood. Research suggest it acts by downregulating microRNA sequences miR-221 and -222, which have been associated with resistance to the cancer drug Nexavar (sorafenib), co-marketed by Bayer. Consequently, Tiziana Life Sciences is also running clinical trials with a combination of milciclib and sorafenib.

A second candidate, foralumab, is in Tiziana’s pipeline as a treatment for Crohn’s disease, NASH and primary biliary cholangitis (PBC). It was licensed from the Swiss Novimmune and presents potential to compete in the profitable and soon crowded NASH space. If its pipeline keeps performing well, Tiziana could provide solutions for some of the most challenging diseases out there.


Images from Shidlovski /Shutterstock; Tiziana Life Sciences 

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