LONDON--(BUSINESS WIRE)--Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, today announces that the independent data monitor committee (IDMC) completed interim analysis of the safety and pharmacokinetic data from the first six patients and concluded that treatment with Milciclib was safe and well-tolerated with no drug-related serious adverse events (SAEs) in patients with unresectable or metastatic HCC. The IDMC recommended continuing with the trial.
- This Phase 2a multi-center and multi-country clinical trial (CDKO-125A-010) in patients with unresectable or metastatic HCC was conducted in Israel, Italy and Greece. Since, this was the first trial with Milciclib in HCC patients, an interim analysis was scheduled to ensure safety of patients with underlying liver cirrhosis.
- Establishment of safety in HCC patients was a key pre-requisite to move forward with the further clinical development of Milciclib. The treatment regimen with Milciclib (100mg/day; 4 days On/3 days Off, every 4 weeks) was safe and well-tolerated with no drug-related SAEs in patients with unresectable or metastatic HCC.
- As a next step, a Phase 2b trial to evaluate safety and clinical activity of Milciclib in combination with sorafenib (Nexavar®; Bayer Germany) in HCC is expected to start in Q2, 2018.
Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented: "unresectable or metastatic HCC is an aggressive type of liver cancer for which no satisfactory treatment is currently available. The establishment of Milciclib’s safety is a significant milestone as it paves way to move forward with clinical studies evaluating Milciclib in combination with sorafenib (Nexavar®; Bayer) or nivolumab (Opdivo®; Bristol Myers Squibb) for treatment of HCC."
Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences, commented: “Safety findings of Milciclib in HCC are consistent with the findings reported earlier on the long-term safety and clinical activity of Milciclib in thymic carcinoma, thymoma1 and other solid cancers2. Results from these clinical studies will facilitate the further clinical development of Milciclib for treatments of HCC and other cancers”.
Cited References
1. Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. Cancer Chemother Pharmacol (2017). Phase I dose-escalation study of Milciclib in combination with gemcitabine in patients with refractory solid tumors. Cancer Chemother Pharmacol. 79:1257-1265.
2. Press Release on announcement of clinical data in thymoma and thymic carcinoma.
About Hepatocellular Carcinoma
Hepatocellular cancer is the 5th most common cancer and the 3rd cause of cancer mortality worldwide. In 2007 the approval by the European Medical Agency (EMA) and Food and Drug Administration (FDA) of sorafenib in HCC represented the first systemic therapy for improving outcome in patients unsuitable for loco-regional and surgical therapies and created a new standard of treatment for the disease. However, although significant in respect to placebo, the benefits of sorafenib are modest; the response rate is less than 3%, the improvement in median survival is 2-3 months and the drug-related symptoms are not ordinary. Therefore, more effective systemic therapy is required for both naive patients presenting with unresectable, advanced stage and those who suffer recurrence after curative treatments (resection, ablation and transplantation).
About Milciclib
Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases (CDKs) such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in thymic carcinoma, pancreatic carcinoma and colon cancer.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology and immunology. The Company is focused on its lead compound Milciclib. The Company is also in clinical development of foralumab. Foralumab is the only fully human engineered anti-CD3 antibody in clinical development. This phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
For more information go to http://www.tizianalifesciences.com
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
The content of this announcement has been reviewed and approved for publication by Dr Kunwar Shailubhai, CEO & CSO of the Company.
