LONDON (Alliance News) - Tiziana Life Sciences PLC on Wednesday reported encouraging interim data from its trial of milciclib in patients with advanced liver cancer.
Shares in Tiziana were up 6.8% at 55.00 pence in early afternoon trade in London.
Biotechnology firm Tizania, which specialises in inflammation and oncology, said 80% of patients who completed treatment within the timeframe of the phase 2a trial have requested continuation of the treatment under compassionate use.
An interim safety review of the trial also found that the drug "was not associated with unexpected signs or signals of toxicity" when administered to patients with advanced hepatocellular carcinoma - a type of liver cancer and the fifth most common cancer worldwide.
Milciclib was administered repeatedly during the six-month study period to ten patients, eight of which wanted to continue treatment while seven were approved to do so under compassionate use. Three of the patients under compassionate use have completed 9, 13, and 16 months of treatment with the drug while four are continuing with the drug.
No drug-related deaths have so far occurred and the drug is well tolerated.
"Demonstration of safety and clinical activity is 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 [US Food & Drug Administration] approved drugs for treatment of [hepatocellular carcinoma] patients," said Tiziana Chief Executive & Chief Scientific Officer Kunwar Shailubhai.
"We previously reported data from preclinical studies demonstrating that milciclib produced pronounced synergistic anti-[hepatocellular carcinoma] activity in combination with any one of the FDA approved drugs such as sorafenib, regorafenib, and lenvatinib," Shailubhai added.
