TILS.L Regulatory News (TILS)

Tiziana Life Sciences plc

("Tiziana" or the "Company")

Presentation at ASCO 3 June 2018

Tiziana Life Sciences Announces a Poster Presentation on Phase II clinical data with Milciclib in Thymic carcinoma and Thymoma patients at the American Society of Clinical Oncology (ASCO) Meeting (June 1-5, Chicago IL)

London, 09 April 2018 - Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, today announces that clinical safety and efficacy data from two phase II clinical trials evaluating treatment of thymic carcinoma and thymoma patients with milciclib will be presented at the ASCO, Chicago IL. In these studies, milciclib, a small molecular pan-inhibitor of cyclin dependent kinases ("CDKs") met primary and secondary endpoints of the studies. The treatment regimen with milciclib (150mg/day; 7days On/7days Off) was safe and well-tolerated with some patients continuing therapy of up to 5 years.

The presentation, "Efficacy of milciclib (PHA-848125AC), a pan-cyclin d-dependent kinase inhibitor, in two phase II studies with thymic carcinoma (TC) and B3 thymoma (B3T) patients" will be given in the "Lung Cancer-Non-Small Cell Local-regional/Small Cell/Other Thoracic Cancers" session on June 3, 2018 from 4:45 PM to 6:00 PM by the principal author and investigator, Benjamin Besse, M.D., Institut Gustave Roussy, Villejuif France. Other investigators and authors of the study include Marina Chiara Garassino, M.D., Arun Rajan, M.D , Silvia Novello, M.D., Ph.D. , Julien Mazieres, M.D., Ph.D , Glen J. Weiss, M.D., Darren Kocs, M.D., Mark Barnett, M.D. , Cristina Davite, PhD. , Patrizia Crivori, Ph.D. and Giuseppe Giaccone, M.D, Ph.D.

MAJOR HIGHLIGHTS OF THE CLINICAL DATA

· Milciclib was efficacious and met progression free survival ("PFS") as the primary endpoint and overall survival ("OS") as a secondary endpoint in two separate phase II multi-centered clinical trials (CDKO-125A-006: 72 patients and CDKO-125A-007: 30 patients) in patients with thymic carcinoma (TC) and thymoma (B3T) conducted in the USA, France and Italy.  

· Thymic carcinoma is an aggressive metastatic malignancy which is generally recognized as being more difficult to treat than thymoma. Milciclib treatment met primary endpoint PFS-3 (34.6 % and 53.8 %) and secondary endpoint OS (23.79 and 17.94 months) in these clinical studies. 

· The Disease Control Rate (DCR), defined as the percentage of patients with Stable Disease (SD), Complete Response (CR) and Partial Response (PR) in evaluable patients of TC was 69.2% in both trials. The DCR in evaluable B3T patients was 80.0% and 70.6% in CDKO-125a-006 and CDKO-125a-007, respectively. 

· Seven patients (5 patients in the CDKO-125A-006 study and 2 patients in the CDKO-125A-007) have been continuing treatment with Milciclib for more than 2 years with excellent safety profile. Among these, 2 patients have been treated with Milciclib for approximately 5 years, demonstrating safety of the drug for long term treatment.

"Thymic carcinoma and thymoma are unmet medical needs with no approved therapies. Particularly, it is very exciting that milciclib treatment was also efficacious in TC, which is an aggressive and difficult to treat metastatic cancer" Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented.

"Demonstration of safety and efficacy in these two phase II clinical studies in patients with TC and B3T is a major milestone in clinical development of milciclib. We will work with regulatory agencies in US and Europe to develop plans to bring these first-in-class therapies to patients in need as soon as possible" said Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences

About Thymic Carcinoma and Thymoma

Thymomas and thymic carcinomas are thymus tumors of epithelial origin. The incidence of thymic malignancies is approximately 1.5% of all malignancies with an overall incidence of 0.15 cases per 100,000. Thymic carcinomas are invasive and represent 0.06% of all thymic cancers, whereas thymomas tend to recur locally and are less likely to metastasize (https://www.cancer.gov/types/thymoma/hp/thymoma-treatment-pdq).

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases 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 signaling 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 NSCLC, Pancreatic and colon cancer, thymic carcinoma and thymoma.

About Tiziana Life Sciences

Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to milciclib, the Company is also developing foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. 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.

About ASCO

The American Society of Clinical Oncology (ASCO) was established in 1964 with the sole purpose of improving the care of people with cancer. Membership currently stands at 40,000 physicians and scientists. ASCO is one of the premiere organizations for the advancement of cancer treatments and the annual ASCO meeting is an important forum for discussion of new cancer therapies and treatments.

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.

Contacts