TILS.L Regulatory News (TILS)

www.tizianalifesciences.com | AIM: TILS

Tiziana Life Sciences PLC ("Tiziana" or the "Company")

Tiziana announces plans for clinical development of foralumab, the company's fully human CD3 antibody

Tiziana adds Profs Kevan Herold and Howard Weiner to Scientific Advisory Board, providing key leadership and experience in CD3 clinical development

London, 11 January 2016 - Tiziana Life Sciences plc (AIM: TILS, the "Company"), a clinical stage biotechnology company focused on targeted drugs to treat diseases in oncology and immunology, today announced its plan for further development of foralumab, the company's fully human anti-CD3 antibody, along with the addition of two key members: Professors Kevan Herold, MD and Howard Weiner, MD who will be joining its Scientific Advisory Board and focusing on pioneering a unique clinical development plan for foralumab. The company will first be evaluating foralumab in two clinical indications: 1) graft vs host disease, and 2) ulcerative colitis, an inflammatory bowel disease.

"The addition of Professors Herold and Weiner to Tiziana's Scientific Advisory Board marks a vital step for the company," said Gabriele Cerrone, Executive Chairman. "Prof. Herold's previous experience in CD3 antibody research will be invaluable in planning the clinical strategy for foralumab, and he will take on a major role in its further development. In addition, Prof. Weiner brings a wealth of expertise in the field of immunology and regulation of processes that govern cancer and autoimmune disease, which will also be critical as we build out our anti-CD3 clinical strategy and the development of our fully human antibody asset, foralumab."

Dr. Kevan Herold is Professor of Immunobiology and of Medicine (Endocrinology) as well as Deputy Director, Yale Center for Clinical Investigation, Director of the Yale Diabetes Center and Director of the TrialNet Center at Yale. His investigative work has focused on developing new ways to prevent and treat autoimmune diseases, using novel translational immunologic and metabolic approaches to prevent progression, in particular anti-CD3 monoclonal antibody therapy. His clinical interests are in the management of endocrine diseases, and he is involved in a number of national and international clinical studies of new treatments.

Dr. Howard Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women's Hospital in Boston. The Partners MS Center is the first integrated MS Center that combines clinical care, MRI imaging and immune monitoring to the MS patient as part of the 2000 patient CLIMB cohort study. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer's disease, amyotrophic lateral sclerosis, stroke and brain tumours. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce regulatory T cells for the treatment of these diseases.

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, a molecule which blocks the action of specific enzymes called cyclin-dependent kinases (CDK) involved in cell division as well as a number of other protein kinases. Milciclib is currently in phase II clinical trials for thymic carcinoma in patients previously treated with chemotherapy.

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 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.

Tiziana Life Sciences' clinical development teams are working on its Bcl-3 candidate; which has a prominent role in the metastasis of mammary cancers, and has elucidated the mechanism of Bcl-3 action to be a regulator of cancer cell motility and has also determined that Bcl-3 inhibition suppresses cell motility in triple-negative, HER-2-positive PR- and ER-positive breast cancer sub-types, suggesting that Bcl-3 may be a master regulator of this metastatic property not only in aggressive breast cancers, but across the clinical spectrum of breast disease. The Company is preparing the IND package with the intention of progressing to clinical trials this year.

For more information go to http://www.tizianalifesciences.com

Forward-Looking Statements

Certain statements in this press release are forward-looking. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on Tiziana's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Tiziana does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

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Source: Tiziana Life Sciences