22nd Jul 2019 09:54
(Alliance News) - Tiziana Life Sciences PLC on Monday said there were no drug related deaths in its phase 2a trial of Milciclib in advanced liver cancer and the drug was well tolerated with some patients continuing to take the drug under compassionate use.
Shares in the biotechnology company were up 4.7% at 62.80 pence in morning trade.
Of the 31 advanced hepatocellular carcinoma patients treated with the drug, 28 were evaluable and 14 completed the 6 month duration of the study. In addition, 9 continued treatment under compassionate use and 5 are presently continuing treatment. Advanced hepatocellular carcinoma is "the most common form of liver cancer".
The study's primary endpoint was overall safety. Milciclib was tolerated and no deaths relating to the drug were recorded. Progression-free survival and time to progression, the secondary endpoints, are still being evaluated.
"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 Tiziana Chief Executive Officer & Chief Scientific Officer Kunwar Shailubhai.
Tiziana said the data was consistent with earlier long-term safety and clinical activity tests of Milciclib in "thymic carcinoma, thymoma and other solid cancers".
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