Accueil / Communiqués / Tiziana Completes Patient Enrollment in a Phase 2a Trial to Evaluate Tolerability and Anti-Tumor Activity of Milciclib in Hepatocellular Carcinoma (HCC)

Tiziana Completes Patient Enrollment in a Phase 2a Trial to Evaluate Tolerability and Anti-Tumor Activity of Milciclib in Hepatocellular Carcinoma (HCC)

Monday, December 3rd 2018 at 8:29am UTC

NEW YORK & LONDON–(BUSINESS WIRE)– 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 14th month and the other two patients
received treatment until 9th month and 13th month,
respectively.

About HCC

HCC is the 5th most common cancer and the 3rd
cause of cancer mortality worldwide. In 2007 the approval by the
European Medical Agency (EMA) and Food and Drug Administration (FDA) of
Sorafenib (Nexavar®), 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®) 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.

Contacts

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

Source: Tiziana Life Sciences plc


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