Milciclib对耐多吉病毒患者的晚期HCC安全

StephenW

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.

Reference: www.tizianalifesciences.com

StephenW

Milciclib对耐多吉病毒患者的晚期HCC安全
2019年4月26日

Tiziana生命科学公司宣布，根据临时安全性审查结果，用milciclib治疗晚期肝细胞癌并未与意外体征或毒性信号相关联。

“安全性和临床活动的证明是推进milciclib进一步临床开发的战略选择的重要里程碑，无论是作为单一药物还是与FDA批准的一种治疗HCC患者的药物联合使用，”Kunwar Shailubhai博士， Tiziana的首席执行官兼首席科学官在发布会上说。


正在进行的2a期临床试验旨在评估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。

研究人员审查了31名登记患者中的28名患者的数据，其中10名患者按照6个剂量周期超过6个月的方案完成了研究。迄今为止，milciclib具有良好的耐受性，可控制的药物相关毒性，并且没有与药物相关的死亡。 7名患者在同情使用下被批准继续使用milciclib，已完成16个月的治疗。

根据Shailubhai的说法，milciclib先前染色协同抗HCC活性与多种FDA批准的药物联合使用，包括索拉非尼，Stivarga（瑞格非尼，拜耳）和Lenvima（lenvatinib，Merck）。

Tiziana预计2019年第三季度末的收入数据。

参考：www.tizianalifesciences.com