用于多吉美抗性肝癌的Milciclib符合其他研究终点

StephenW

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.”

Reference: www.tizianalifesciences.com

StephenW

用于多吉美抗性肝癌的Milciclib符合其他研究终点
2019年9月5日

Tiziana生命科学公司提供了另外的正面数据，这些数据来自正在进行的针对无法切除或转移性肝细胞癌患者以及对多吉美耐药或不耐受的milciclib 2a期临床试验。

此前，该公司宣布观察到的良好安全性和耐受性符合主要研究终点。随访分析显示，milciclib还达到了进展时间和无进展生存期的次要终点。


“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。“

研究人员设计了正在进行的2a期临床试验，以评估milciclib患者的安全性，耐受性和抗肿瘤活性，这些患者对Nexavar（索拉非尼，拜耳）耐药或不耐受的不可切除或转移性晚期HCC。

28名可评估患者中有14名完成了为期6个月的试验，其中9名患者在获得委员会批准后继续接受治疗，4名患者在2019年9月1日继续接受治疗。中位进展时间和无进展生存期均为5.9个月（95％CI，1.5-6.7）。

此外，17名可评估的患者表现出“稳定的疾病”，1名患者表现出“部分反应”，18名患者表现出“临床受益率”。

参考：www.tizianalifesciences.com