What's Going On With Small-Cap Cancer Focused XBiotech On Tuesday?
What's Going On With Small-Cap Cancer Focused XBiotech On Tuesday?
The Phase 1 portion was a dose escalation study in metastatic pancreatic cancer patients to determine if dose-limiting toxicities occurred in combination with the ON+5FU+LV regimen in a second- or third-line setting.Tuesday, XBiotech Inc (NASDAQ:XBIT) announced data from its Phase 1/Phase 2, 1-BETTER Study for advanced pancreatic cancer.
周二，XBiotech公司（纳斯达克：XBIT）公布了其用于先进胰腺癌的1-BETTER研究的1/2期数据。
The study examined the Natrunix (anti-interleukin-1alpha) antibody in combination with an established chemotherapy regimen (ONIVYDE (ON) + 5-Fluorouracil (5FU) + Leucovorin (LV)), which is already widely used for treating pancreatic cancer but is associated with difficult toxicities and less-than-ideal survival outcomes.
该研究检查了Natrunix（抗白细胞介素-1α抗体）与已广泛用于胰腺癌治疗但与副作用大和不理想的生存结果相关的已建立的化疗方案（ONIVYDE（ON）+5-氟尿嘧啶（5FU）+亚叶酸钙（LV））的联合应用。
Natrunix was being evaluated as an anti-cancer agent for use in cytotoxic chemotherapy combinations where the company believes it might potentially also improve tolerability of the chemotherapy.
Natrunix正在作为抗癌剂在细胞毒性化疗联合用药中进行评估，公司认为它可能也可以改善化疗的耐受性。
The Phase 1 portion was a dose escalation study in metastatic pancreatic cancer patients to determine if dose-limiting toxicities occurred in combination with the ON+5FU+LV regimen in a second- or third-line setting.
第1阶段是转移性胰腺癌患者的剂量递增研究，以判断与第二或第三行使用的ON + 5FU + LV方案相结合是否存在剂量限制性毒性。
DLTs were not expected with Natrunix and none were seen. The Natrunix dose in the Phase 2 portion was thus the highest dose used in the Phase 1 portion.
Natrunix不应出现剂量限制毒性反应，并且没有观察到这种反应。因此，第2阶段中的Natrunix剂量是第1阶段使用的最高剂量。
The primary endpoint for the Phase 2 study was to assess the safety and tolerability of Natrunix when used with the ON+5FU+LV combination.
第2阶段研究的主要终点是评估当与ON+5FU+LV联合使用时，Natrunix的安全性和耐受性。
Overall, there were fewer adverse events (AEs) during the 24-week treatment period for the Natrunix arm compared to placebo (297 vs 336), with markedly fewer events in specific categories of adverse events during that time.
总体上说，在Natrunix组24周的治疗期间，与安慰剂组（297与336）相比，特定类别的不良事件数量更少。
Subjects receiving the Natrunix ON+5FU+LV regimen also had about a 33% reduction in hospitalization (80 days versus 120 days).
接受Natrunix ON+5FU+LV方案的受试者也减少了约33％的住院时间（80天与120天）。
Subjects receiving the Natrunix combination also reported a 22% reduction in fatigue, 32% improved appetite, and 41% reduction in pain.
接受Natrunix联合用药的受试者还报告了22％的疲劳减少，32％的食欲改善和41％的疼痛减少。
The incidence of severe diarrhea was twofold (9% versus 19%) lower during the 24-week treatment regimen for patients receiving the Natrunix + ON+5FU+LV combination compared to placebo + ON+5FU+LV.
在接受Natrunix + ON+5FU+LV组合治疗的患者中，24周治疗周期期间严重腹泻的比例比接受安慰剂+ON+5FU+LV组合治疗的患者低两倍（9％与19％）。
Overall Survival (OS) is one of the secondary endpoints for the Phase 2 study. The data highlights the observation that no subjects in the placebo ON+5FU+LV group (n=32) survived for longer than 330 days, whereas eight subjects in the Natrunix ON+5FU+LV arm (n=33) were still alive as of day 330.
总体生存率（OS）是第2阶段研究的次要终点之一。数据强调了观察到的一个现象，即安慰剂ON+5FU+LV组（n = 32）的受试者在330天以后都没有生存，而Natrunix ON+5FU+LV组（n = 33）的8个受试者截至第330天仍然存活。
Considering the small sample size, the borderline statistically significant p-value of p = 0.096 suggests prolonged survival for subjects receiving the Natrunix regimen.
考虑到样本量较小，边缘统计显著的p值为p = 0.096表明接受Natrunix方案的受试者的生存期可能会延长。
Price Action: XBIT shares are down 9.54% at $5.50 at last check Tuesday.
XBIT股票最近报价5.50美元，跌幅为9.54％。
Image by PDPics from Pixabay
来自Pixabay的PDPics图片
