Milciclib for Nexavar-resistant liver cancer meets additional study endpoints
September 5, 2019
Tiziana Life Sciences provided additional positive data from the ongoing phase 2a clinical trial of milciclib for patients with unresectable or metastatic hepatocellular carcinoma and resistance or intolerance to Nexavar.
Previously, the company announced that the favorable safety and tolerance profile observed met the primary study endpoint. Follow-up analyses revealed that milciclib also met the secondary endpoints of time-to-progression and progression-free survival.
“The current therapies for HCC are often associated with severe toxicities, resulting in poor patient compliance,” Gabriele Cerrone, chairman and founder of Tiziana Life Sciences, said in a press release. “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.”
Investigators designed the ongoing phase 2a clinical trial 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).
Fourteen of the 28 evaluable patients completed the 6-month trial, nine of whom continued treatment after approval by committee and four have continued treatment as of Sept. 1, 2019. Both median time-to-progression and progression-free survival were 5.9 months (95% CI, 1.5-6.7).
Additionally, 17 of the evaluable patients demonstrated “stable disease,” one patient demonstrated “partial response,” and 18 demonstrated “clinical benefit rate.”
“目前HCC的治疗方法通常伴有严重的毒性，导致患者依从性差，”Tiziana Life Sciences董事长兼创始人Gabriele Cerrone在一份新闻稿中表示。 “因此，迫切需要有效的治疗方法，不会影响患者的生活质量。我们相信milciclib的整体安全性比目前用于治疗HCC的现有疗法具有重要的竞争优势。“