Tiziana Life Sciences Announces Publication of Peer-Reviewed Paper from Positive Clinical Trial of Milciclib in Patients with Refractory Solid Tumours

Encouraging data from phase I study published in Cancer Chemotherapy and Pharmacology

LONDON, UK I April 21, 2017 I Tiziana Life Sciences plc (AIM:TILS, the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer and autoimmune diseases, is pleased to announce that a research article detailing the use of the Company’s lead compound, milciclib, has been published in the prestigious, peer-reviewed journal Cancer Chemotherapy and Pharmacology, entitled: “Phase I Dose-Escalation Study of Milciclib, A Novel Inhibitor of Cyclin Dependent Kinases (CDKs), in Combination with Gemcitabine in Patients with Refractory Solid Tumors"1.

In this phase I clinical trial, 16 patients with advanced metastatic tumours, refractory to existing cancer therapies, were enrolled. The treatment regimen consisted of oral treatment with milciclib once daily for 7 days on/7 days off in a 4-week cycle with concomitant gemcitabine administered intravenously once weekly for 4 weeks. This combination treatment regimen showed positive clinical responses in approximately 36% of patients, including gemcitabine refractory patients. One patient with non-small cell lung carcinoma (NSCLC), showed partial response and four patients (one each with thyroid, prostatic, pancreatic carcinoma and peritoneal mesothelioma) showed long-term disease stabilisation for up to 14 months. In previous clinical studies, oral treatment with milciclib, was found be safe and well tolerated in patients with thymoma and thymic cancers.

Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented: "Following the generation of encouraging phase I clinical data with milciclib, reported in this important publication, we are rapidly moving forward with further evaluation of the drug as an oral treatment in phase IIa clinical trials for patients with refractory hepatocellular carcinoma (HCC), which is a significant unmet medical need. It is noteworthy that the combination treatment regimen used in the phase I study also exhibited positive clinical activity in patients who were previously resistant to treatment with gemcitabine, a drug widely used as a partner in combination therapies for treatment of refractory cancers. This suggests that milciclib may have therapeutic potential in combination with other existing therapies.”

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. Oral treatment with milciclib was found to be effective in reducing tumour growth in animal models of HCC, possibly through downregulation of miR-221 and miR-222. 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 Gemcitabine

Gemcitabine, a well-known nucleoside analogue sold under the brand name Gemzar®, is a widely used chemotherapeutic drug used either as a monotherapy or in combination with other anti-cancer agents for treatment of a wide range of solid tumours. Synergism between CDK inhibitors and gemcitabine has been shown in animal studies as well as in a phase I trial with cancer patients.

About Cancer Chemotherapy and Pharmacology

Cancer Chemotherapy and Pharmacology is a journal addressing a wide range of pharmacologic and oncologic concerns on both experimental and clinical levels. Primary focus in this rapid publication medium is on new anticancer agents, their experimental screening, preclinical toxicology and pharmacology, single and combined drug administration modalities, and clinical phase I, II and III trials. It is essential reading for pharmacologists and oncologists. The journal is published by Springer, which is part of Springer Nature, a global publisher that serves and supports the research community.

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-human CD3 antibody in clinical development. This phase II 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

1 Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. Cancer Chemother Pharmacol (2017). doi:10.1007/s00280-017-3303-z

SOURCE: Tiziana Life Sciences

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