Tiziana Life Sci PLC - Phase 2a Clinical Data
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Tiziana Reports Phase 2a Clinical Data with Milciclib Monotherapy in Sorafenib-refractory or -intolerant patients with unresectable or metastatic Hepatocellular Carcinoma
· Milciclib was well tolerated and no drug related deaths were reported
· 28 out of 31 treated patients were evaluable, with 14 patients completing the 6-month study duration
· 9 patients continued treatment under compassionate use, of which 5 are currently continuing with treatment
This Phase 2a trial with Milciclib monotherapy was a multi-centered, 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. This trial enrolled 31 patients in
Among the 28 evaluable patients, 14 completed the 6-month duration study. Oral treatment with Milciclib was well-tolerated with manageable toxicities. The most frequent adverse events such as diarrhea, ascites, nausea, fatigue, asthenia, fever, ataxia, headache, and rash were manageable.
9 out of the 14 patients, after completing the 6-month trial period, requested to continue the treatment under compassionate use and were approved by their respective ethical committees. Four of the patients received Milciclib for a total of 9, 11, 13 and 16 months. The remaining 5 patients are continuing treatment with Milciclib are at 8th, 9th, 9th, 9th and 11th month currently.
Objective tumor assessments according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) guideline and the conventional RECIST 1.1 criteria are being conducted by Independent Central Review and data will be available in
"We are very pleased with the clinical activity and tolerability of Milciclib in these advanced cases of HCC. It is an important milestone to move forward with further clinical development of Milciclib either as a single agent or in combination with other HCC drugs," said Dr.
These data are consistent with the earlier reported long-term safety and clinical activity of Milciclib in thymic carcinoma, thymoma1 and other solid cancers2.
The global market for liver cancer drugs is estimated to reach
The person who arranged for the release of this announcement on behalf of the Company was Dr
1. Besse, B., Garassino, M., Rajan, A., Novello, S., Mazieres, J.,
2. 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.
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HCC is the fifth most common cancer and the third highest cause of cancer mortality worldwide. In 2007, the approval by the
Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, 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.
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