London, 8 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, announced today that its research agreement with Cardiff University, focused on pioneering the development of Bcl-3 inhibitors as potential drugs to treat cancer, has led to the identification of a first-in-class lead clinical candidate, CB1, with potent anti-metastatic activity, and with an impressive in vivo efficacy and safety profile.
The Company intends to file an Investigational New Drug (IND) application on CB1 in 2016, and expects to move this drug candidate into clinical trials before the end of the year.
The original research agreement between Tiziana Life Sciences and Cardiff University, focused on pioneering the development of Bcl-3 inhibitors as potential drugs to treat cancer, has been expanded to include an additional research program focused on eradication of breast cancer stem cells through inhibition of a protein known as c-FLIP, which is also being supported by the Company.
The Company-sponsored research at Cardiff University has attracted significant media attention as well as the interest of the Welsh Government and charity-based sources, where funders such as the Life Science Research Network of Wales and Cancer Research Wales have sponsored further research work including potential combination of Bcl-3 inhibitors with radiotherapy. Other academic groups working on Bcl-3 have helped to broaden the potential market for Bcl-3 inhibitors into other cancer types where Bcl-3 plays an important role; examples here include UK collaborations in metastatic colorectal cancer (Bristol) and internationally in nasopharyngeal cancer (Hong Kong).
"Our partnership in the development of this unique molecule CB1 is an excellent example of how biotechnology companies, working collaboratively with cutting-edge prestigious research institutions such as Cardiff University, can create life changing drugs and further promote research into difficult-to-treat diseases," said Jim Tripp, Chief Operating Officer of Tiziana Life Sciences.
World-leading research from the group of Dr. Richard Clarkson within the Cardiff-based European Cancer Stem Cell Institute has established that Bcl-3 is essential for breast cancer metastasis in experimental models, a result with profound implications, given the scarcity of validated anti-metastatic drug targets. The Clarkson group along with drug discovery experts Drs. Andrea Brancale and Andrew Westwell from the University School of Pharmacy and Pharmaceutical Sciences have designed novel Bcl-3 inhibitors that exhibit dramatic inhibition of metastatic lesion formation in mouse models of cancer.
c-FLIP (cellular FLICE (FADD-like IL-1β-converting enzyme)-inhibitory protein) is a known suppressor of apoptosis (programmed cell death). c-FLIP acts inside the cell by preventing the instructive cell death that occurs when a signal protein produced by neighbouring cells attaches to the target cell's surface. c-FLIP blocks this death signal from entering the cell. Suppression of apoptosis is a recognised driver of cancer cell proliferation, thus by inhibiting this suppression it should be possible for cell death to occur and proliferation of cancer to be thwarted. The Cardiff team are working to expand application of this unusual approach to other tumour types.
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
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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