Milciclib safe for advanced HCC in patients resistant to Nexavar
April 26, 2019
Tiziana Life Sciences announced that treatment with milciclib for advanced hepatocellular carcinoma did not correlate with unexpected signs or signals of toxicity based on results from an interim safety review, according to a press release.
"Demonstration of safety and clinical activity is an 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 FDA approved drugs for treatment of HCC patients," Kunwar Shailubhai, PhD, CEO and chief scientific officer of Tiziana, said in the release.
The ongoing phase 2a clinical trial was designed to evaluate the safety, tolerability and anti-tumor activity of milciclib patients with unresectable or metastatic advanced HCC who are resistant or intolerant to Nexavar (sorafenib, Bayer).
Researchers reviewed data from 28 of 31 enrolled patients, 10 of whom have completed the study per protocol of six dose cycles over 6 months. To date, milciclib was well-tolerated with manageable drug-related toxicities and no drug-related deaths. Seven patients approved to continue milciclib under compassionate use have completed 16 months of treatment.
According to Shailubhai, milciclib previously dye synergistic anti-HCC activity in combination with multiple FDA-approved drugs including sorafenib, Stivarga (regorafenib, Bayer) and Lenvima (lenvatinib, Merck).
Tiziana expects topline data by the end of third-quarter 2019.