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.
週二，XBiotech公司（納斯達克：XBIT）公佈了其用於先進胰腺癌的1-BETTER研究的1/2期數據。
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.
該研究檢查了Natrunix（抗白細胞介素-1α抗體）與已廣泛用於胰腺癌治療但與副作用大和不理想的生存結果相關的已建立的化療方案（ONIVYDE（ON）+5-氟尿嘧啶（5FU）+亞葉酸鈣（LV））的聯合應用。
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正在作爲抗癌劑在細胞毒性化療聯合用藥中進行評估，公司認爲它可能也可以改善化療的耐受性。
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階段是轉移性胰腺癌患者的劑量遞增研究，以判斷與第二或第三行使用的ON + 5FU + LV方案相結合是否存在劑量限制性毒性。
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不應出現劑量限制毒性反應，並且沒有觀察到這種反應。因此，第2階段中的Natrunix劑量是第1階段使用的最高劑量。
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階段研究的主要終點是評估當與ON+5FU+LV聯合使用時，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.
總體上說，在Natrunix組24周的治療期間，與安慰劑組（297與336）相比，特定類別的不良事件數量更少。
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方案的受試者也減少了約33％的住院時間（80天與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聯合用藥的受試者還報告了22％的疲勞減少，32％的食慾改善和41％的疼痛減少。
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組合治療的患者中，24周治療週期期間嚴重腹瀉的比例比接受安慰劑+ON+5FU+LV組合治療的患者低兩倍（9％與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.
總體生存率（OS）是第2階段研究的次要終點之一。數據強調了觀察到的一個現象，即安慰劑ON+5FU+LV組（n = 32）的受試者在330天以後都沒有生存，而Natrunix ON+5FU+LV組（n = 33）的8個受試者截至第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.
考慮到樣本量較小，邊緣統計顯著的p值爲p = 0.096表明接受Natrunix方案的受試者的生存期可能會延長。
Price Action: XBIT shares are down 9.54% at $5.50 at last check Tuesday.
XBIT股票最近報價5.50美元，跌幅爲9.54％。
Image by PDPics from Pixabay
來自Pixabay的PDPics圖片
