TIDMTILS
RNS Number : 9779W
Tiziana Life Sciences PLC
24 April 2019
THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS DEEMED BY THE
COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU
MARKET ABUSE REGULATION (596/2014). UPON PUBLICATION OF THE
ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION
IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Reissue
The following announcement is a reissue of the announcement
released on 24 April at 7:00am under RNS 8676W. The reissue is
being made due to formatting issues on RNS 8676W
Tiziana Reports encouraging interim clinical data from an
ongoing Phase 2a Clinical Trial with Milciclib in Patients with
advanced liver cancer
-- 80% of patients who completed treatment within the trial's
timeframe requested to continue treatment on compassionate use
grounds
-- Independent Data Monitoring Committee finds no unexpected signs or signals of toxicity
-- Top line data expected Q3 2019
New York/London, 24 April 2019 - 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, today announced results from
the interim safety review conducted by the Independent Data
Monitoring Committee ("IDMC") on 21 March 2019. The IDMC reviewed
safety data from patients as of 26 February 2019, and concluded
that the administration of milciclib to patients with advanced
hepatocellular carcinoma ("HCC") was not associated with unexpected
signs or signals of toxicity. Additionally, a number of patients
are continuing with treatment under compassionate use. Topline data
from this multi-center trial is expected to be available by the end
of Q3 2019.
Tiziana's Milciclib Phase 2a clinical trial is a single-arm,
repeated-dose (100 mg once daily; 4 days on/3 days off every 4
weeks defining each cycle), 6-month duration study to evaluate the
safety, tolerability and anti-tumor activity of Milciclib in
Sorafenib-refractory or intolerant patients with unresectable or
metastatic advanced HCC, the most common form of liver cancer.
Enrollment of 31 patients in Italy, Greece, and Israel was
completed on 30 November 2018.
The IDMC evaluated data from 28 out of the 31 patients who were
evaluable. As of 16 April 2019, a total of 10 out of 27 patients
have completed the study per protocol (6 cycles, 6 months). Four
patients are still under treatment, while 3 are in cycle 6 and 1 is
in cycle 5. Eight out of the 10 patients who completed treatment
initially expressed interest to continue with treatment. Seven of
these 8 patients were approved to continue with treatment under
compassionate use by their respective ethical committees.Three of
the patients under compassionate use have completed 9, 13, and 16
months of treatment with Milciclib. The other 4 patients are
continuing with treatment.
To date, no drug-related deaths have been recorded. Overall, the
treatment with Milciclib is well-tolerated with manageable
drug-related toxicities. These safety and clinical activity are
consistent with the earlier reported long-term safety and clinical
activity of Milciclib in thymic carcinoma, thymoma and other solid
cancers.
"Demonstration of safety and clinical activity is an important
milestone to move forward with strategic options for further
clinical development of Milciclib either as a single agent or in
combination with one of the FDA approved drugs for treatment of HCC
patients," said Dr Kunwar Shailubhai, CEO & CSO of Tiziana. "We
previously reported data from preclinical studies demonstrating
that Milciclib produced pronounced synergistic anti-HCC activity in
combination with any one of the U.S. Food and Drug Administration
approved drugs such as sorafenib (Nexavar(R)), regorafenib
(Stivarga(R)), and lenvatinib (Lenvima(R))."
The person who arranged for the release of this announcement on
behalf of the Company was Dr Kunwar Shailubhai, CEO of Tiziana.
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 0880
Liam Murray / Jo Turner
Stockdale Securities Limited (Broker)
Andy Crossley / Antonio Bossi +44 (0)20 7601 6125
Cited References
Besse, B,, Garassino, M,, Rajan, A., Novello, S.,Mazieres, J.,
Weiss, G., Kocs, D., Barnett, J, Davite, C, Crivori, P and G.
Giaccone. Efficacy of Milcicilib (PHA-848125AC), a pan-cyclin D
-dependent kinase inhibitor in tow phase II studies with Thymic
carcinoma and B3 thymoma patients. (2018) J. Clin. Onc 36 (15
suppl): 8519
Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. (2017). Phase
I dose-escalation study of milciclib in combination with
gemcitabine in patients with refractory solid tumors. Cancer
Chemother Pharmacol. 79:1257-1265.
Jindal, A., Palejwala, V. and Shailubhai, K. (2018). Oral
treatment with milciclib either alone or in combination with
sorafenib inhibited tumor growth in an orthotopic model of
hepatocellular carcinoma. Hepatology 68 Number 1 (Suppl): 879A
(Abstract 1543)
About HCC
HCC is the fifth most common cancer and the third highest cause
of cancer mortality worldwide. In 2007, the approval by the
European Medical Agency and U.S. Food and Drug Administration 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, with a response rate less than
3%, an improvement in median survival of 2-3 months and
drug-related symptoms that are not ordinary. More recently,
lenvatinib (Lenvima (R)), another multi-tyrosine kinase inhibitor
was also approved for first line treatment of HCC. 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 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.
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END
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