TIDMTILS
RNS Number : 1886K
Tiziana Life Sciences PLC
09 April 2018
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 G(1) 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
Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder +44 (0)20 7493 2853
Cairn Financial Advisers LLP (Nominated adviser)
Liam Murray / Jo Turner +44 (0)20 7213 0883
This information is provided by RNS
The company news service from the London Stock Exchange
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