Syros Pharmaceuticals Stock Sinks As Pivotal Blood Cancer Trial Flunks, Triggers Loan Default
Syros Pharmaceuticals Stock Sinks As Pivotal Blood Cancer Trial Flunks, Triggers Loan Default
In the first 190 enrolled patients, the complete response rate by intent-to-treat (ITT) in the tamibarotene/azacitidine treatment arm was 23.8% compared to 18.8% in the placebo/azacitidine control arm and was not statistically significant (p-value = 0.2084).Syros Pharmaceuticals Inc (NASDAQ:SYRS) revealed on Tuesday that the SELECT-MDS-1 Phase 3 trial of tamibarotene did not meet its primary endpoint of complete response rate.
錫羅斯製藥公司（納斯達克股票代碼：SYRS）週二透露，他米巴羅汀的SELECT-MDS-1三期試驗未達到其完全回覆率的主要終點。
The trial assessed tamibarotene in combination with azacitidine in newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA gene overexpression.
該試驗評估了新診斷的高危骨髓增生異常綜合徵（HR-MDS）患者的他米巴羅汀與阿扎胞苷聯合使用。
Myelodysplastic syndrome is a rare blood cancer that occurs when the DNA in bone marrow stem cells is damaged, preventing them from producing healthy blood cells.
骨髓增生異常綜合徵是一種罕見的血液癌，發生在骨髓幹細胞中的DNA受損，使它們無法產生健康的血細胞。
In the first 190 enrolled patients, the complete response rate by intent-to-treat (ITT) in the tamibarotene/azacitidine treatment arm was 23.8% compared to 18.8% in the placebo/azacitidine control arm and was not statistically significant (p-value = 0.2084).
在前190名入組的患者中，他米巴羅汀/阿扎胞苷治療組按治療意向（ITT）計算的完全緩解率爲23.8％，而安慰劑/阿扎西替丁對照組的完全緩解率爲18.8％，並且沒有統計學意義（p值= 0.2084）。
Bristol Myers Squibb & Co (NYSE:BMY) markets azacitidine as Vidaza.
百時美施貴寶公司（紐約證券交易所代碼：BMY）以Vidaza的名義銷售阿扎胞苷。
In the safety analysis of all enrolled patients (n=245), tamibarotene combined with azacitidine (n=160) appeared to be generally well-tolerated, with an adverse event profile similar to that seen in earlier Syros-sponsored studies.
在對所有入組患者（n=245）的安全性分析中，他米巴羅汀聯合阿扎胞苷（n=160）的耐受性普遍良好，其不良事件特徵與Syros贊助的早期研究相似。
Syros also reported, as previously disclosed in its filings with the U.S. Securities and Exchange Commission (SEC), the failure of the SELECT-MDS-1 trial to achieve its primary endpoint constitutes an event of default under its secured loan facility with Oxford Finance.
Syros還報告說，正如先前在向美國證券交易委員會（SEC）提交的文件中披露的那樣，SELECT-MDS-1試驗未能實現其主要終點構成了其與牛津金融的擔保貸款機制下的違約事件。
"We are deeply disappointed by this outcome, particularly for the HR-MDS patients who are seeking a new treatment option for this challenging disease," said Conley Chee, CEO of Syros. "We plan to stop the study, review the clinical data more thoroughly and evaluate the next steps."
Syros首席執行官Conley Chee表示：「我們對這一結果深感失望，特別是對於正在爲這種具有挑戰性的疾病尋求新治療選擇的HR-MDS患者而言。」「我們計劃停止研究，更全面地審查臨床數據並評估下一步行動。」
In August, Syros Pharmaceuticals discontinued enrollment in the SELECT-AML-1 Phase 2 trial, which evaluated a triplet regimen of tamibarotene in combination with venetoclax and azacitidine compared to a doublet regimen of venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and RARA gene overexpression.
8月，Syros Pharmicals停止了Select-AML-1二期試驗的入組，該試驗評估了對新診斷的急性髓系白血病（AML）和RARA基因過度表達患者的維內托克拉克斯和阿扎西替丁的雙聯療法的比較，該試驗評估了他米巴羅汀與venetoclax和阿扎西替丁聯合療法的三聯療法。
The company said the probability of the SELECT-AML-1 study's success in demonstrating superiority in the final analysis of 80 randomized patients was considered low.
該公司表示，Select-AML-1研究在對80名隨機患者的最終分析中成功顯示出優勢的可能性被認爲很低。
SYRS Price Action: SYRS stock is down 86.43% at 37 cents at last check Wednesday.
SYRS價格走勢：週三最後一次檢查時，SYRS股價下跌86.43％，至37美分。
- McDonald's Franchisee Arcos Dorados Beats On Q3 Earnings, Systemwide Comparable Sales Jump
- 麥當勞加盟商阿科斯·多拉多斯第三季度收益超過預期，全系統可比銷售額增長
Photo: Shutterstock
照片：Shutterstock
