4th Sep 2019 11:04
(Alliance News) - Tiziana Life Sciences PLC on Wednesday announced positive data from its study of Milciclib in patients with advanced liver cancer.
Shares in Tiziana were up 19% at 57.00 pence in London in morning trade.
Clinical data from the phase 2a trial suggested "positive clinical activity" in terms of progression-free survival and time to progression.
The patients enrolled in the trial had hepatocellular carcinoma, a liver cancer and the fifth most common cancer worldwide, and were resistant or intolerant to the drug Sorafenib.
Half of the patients, 14 out of 28, completed the six-month trial and nine of these were approved to continue treatment. Of these, two received Milciclibon compassionate use for nine months, one for 11 months, one for 13 months, and one for 16 months.
Of the four remaining patients still continuing treatment, one is on month 10, two on month 11, and one on month 12. One patient showed partial response to the drug.
The median time to progression ad progression-free survival was 5.9 months of the 6 month trial. Bayer competitor Sorafenib had a median time to progression of 5.5 months in a phase 3 trial.
Tiziana Founder & Chair Gabriele Cerrone said: "The current therapies for [hepatocellular carcinoma] are often associated with severe toxicities, resulting in poor patient compliance. Hence, there is an immediate need for efficacious therapies that will not compromise patients' quality of life. We believe that the overall safety profile of Milciclib is an important competitive advantage over existing therapies currently used for treating HCC."
The primary endpoint of the study was overall safety, which has already been met and was announced in July.
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