London, 9 December 2015 - Tiziana Life Sciences plc (AIM: TILS, the "Company"), a clinical stage biotechnology company (headquartered in London, UK) focused on the discovery and development of novel molecules that treat human disease in oncology and immunology, announced today the addition of James (Jim) Tripp, as Chief Operating Officer (COO) and Head of Global Clinical Operations. Mr. Tripp, who will be responsible for all operations, including global clinical development for the Company, is not being appointed to the plc board.
Mr. Tripp has over twenty years' experience in biopharmaceutical operations and has been involved in all phases of drug development from discovery through commercialization. He started his career in pharmaceuticals while attending Harvard School of Public Health and at Massachusetts General Hospital in Boston, MA. Before joining the Company he was Director, Clinical Management at Novo Nordisk, A/S, where he managed the US team overseeing the oral insulin/GLP-1 portfolio, expanding the Victoza? label, and completing confirmatory studies required for Saxenda? which was recently approved to treat obese patients. Prior to Novo Nordisk, Mr. Tripp was employed at Regeneron Pharmaceuticals (REGN:Nasdaq) where he started as a Therapeutic Area Project Manager for inflammation programs, focusing on developing IL-1 Trap (now Arcalyst®) and then creating and heading up the Clinical Compliance & Training group for the Clinical & Project Management Office.
"We are delighted that Jim has agreed to join Tiziana," said Gabriele Cerrone, Executive Chairman of Tiziana. "Jim's considerable experience as one of the early clinical employees at Regeneron during its early stages of clinical development will be of great value as we build Tiziana and expand our clinical activities. Jim will be leading the next phase of Tiziana's development as we begin the design and execution of clinical trials for our multiple novel candidates."
"This is a very exciting time to be joining Tiziana Life Sciences," said James Tripp. "I am very excited about the programs that have been building at Tiziana, and am particularly pleased to be joining the Company at this important time as we look forward to filing two new INDs in 2016."
Mr. Tripp's numerous accomplishments include:
• Leading the creation of departments/functions at Regeneron Pharmaceuticals with a focus on high quality data, team driven metrics and efficient systems; to improve production, communication and transparency
• Executing priority review studies in IL-1 Trap; marketed as Arcalyst® to treat CAPS and in ensuring the BLA submission for Eylea™ was of the highest quality in preparation for regulatory scrutiny
• Developing governance structures, overseeing post marketing mega trials and PMR/PMC registries, e.g., GLP-1 Medullary Thyroid Carcinoma (MTC) registry for Victoza?
• Expanding drug product labels on both Nasonex® and Clarinex® while functioning in Portfolio Management at Schering-Plough (now Merck)
• Overseeing global trials and managing the successful co-development collaborations with GSK, while at Bayer Pharmaceuticals on Baycol® and while at Hoffman-La Roche on Boniva®
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' research team has discovered that Bcl-3 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. Tiziana 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 anticipates that Bcl-3 will progress to clinical trials in 2016.
For more information go to http://www.tizianalifesciences.com
Tiziana Life Sciences plc
Gabriele Cerrone, Chairman
+44 (0)20 7493 2853
Cairn Financial Advisers LLP (Nominated adviser)
Liam Murray / Avi Robinson
+44 (0)20 7148 7900
Beaufort Securities Limited (Broker)
+44 (0)20 7382 8300
Simon Conway / Rob Winder / Natalie Garland-Collins
+44 (0)20 3727 1000