Tiziana Life Sciences PLC Milciclib HCC Phase IIa Trial Enrollment Completed (1439J)
December 03 2018 - 2:01AM
UK Regulatory
TIDMTILS
RNS Number : 1439J
Tiziana Life Sciences PLC
03 December 2018
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Tiziana Completes Patient Enrollment in a Phase 2a Trial to
Evaluate Tolerability and Anti-Tumor Activity of Milciclib in
Hepatocellular Carcinoma (HCC)
New York/London, 3 December 2018 - Tiziana Life Sciences plc
(Nasdaq: TLSA / AIM: TILS), a biotechnology company focusing on the
discovery and development of innovative therapeutics for
inflammation and oncology indications, announces that patient
enrollment in the ongoing Phase 2a clinical trial (CDKO-125A-010)
is completed. This is a single-arm, repeated-dose, 6-month duration
study to evaluate safety, tolerability and anti-tumor activity of
Milciclib in Sorafenib-refractory or -intolerant patients with
unresectable or metastatic HCC. Topline data from this multi-center
trial, being conducted in Italy, Greece and Israel, will be
available in the second quarter of 2019.
Previously we reported interim analysis data from the first 10
patients, following 6 months of treatment, showing that Milciclib
(100 mg once daily; 4 days on/3 days off every 4 weeks defining
each cycle) was well-tolerated in this HCC patient population. It
was concluded by an Independent Data Monitoring Committee (IDMC)
that there were no major signals of tolerability concerns, and the
IDMC allowed continuation of patient enrollment in the trial.
Following completion of 6 months of treatment, three patients opted
to continue treatment under the compassionate use program. Notably,
one patient is still continuing treatment in the 14(th) month and
the other two patients received treatment until 9(th) month and
13(th) month, respectively.
About HCC
HCC is the 5(th) most common cancer and the 3(rd) cause of
cancer mortality worldwide. In 2007 the approval by the European
Medical Agency (EMA) and Food and Drug Administration (FDA) of
Sorafenib (Nexavar(R)), an inhibitor of several receptor tyrosine
kinases, in HCC represented the first systemic therapy for
improving outcome in patients unsuitable for loco-regional and
surgical therapies and created a new standard of treatment for the
disease. However, although significant in respect to placebo, the
benefits of Sorafenib are modest; the response rate is less than
3%, the improvement in median survival is 2-3 months and the
drug-related symptoms are not ordinary. The complex multi-factorial
etiology of HCC warrants a need for systemic therapies that target
different signaling cascades to provide improved efficacy and
safety for both naive patients presenting with unresectable,
advanced stage and those who suffer recurrence after curative
treatments (resection, ablation and transplantation).
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 associated with development of
resistance towards chemotherapies. In a Phase 1 study, oral
treatment with Milciclib was 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. Additionally, milciclib met its primary
endpoint in two separate Phase 2 multi-center clinical trials
(CDKO-125A-006: 72 patients and CDKO-125A-007: 30 patients) in
thymic carcinoma and thymoma patients.
About Sorafenib
Sorafenib (co-developed and co-marketed by Bayer and Onyx
Pharmaceuticals as Nexavar(R)) is a small molecular multi-tyrosine
kinase inhibitor drug approved for the treatment of primary kidney
cancer (advanced renal cell carcinoma), HCC, and radioactive iodine
resistant advanced thyroid carcinoma. Treatment with Sorafenib
induces autophagy, which may suppress tumor growth. However,
autophagy can also cause drug resistance.
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 2
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.
For further enquiries:
Tiziana Life Sciences plc +44 (0)20 7493 2853
Gabriele Cerrone, Chairman and founder
Cairn Financial Advisers LLP (Nominated adviser) +44 (0)20 7213 0883
Liam Murray / Jo Turner
Stockdale Securities Limited (Broker)
Andy Crossley / Antonio Bossi +44 (0)20 7601 6125
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