Small Cap-Cardiff Oncology Outlines Data From Discontinued Colorectal Cancer Trial, Stock Soars
Small Cap-Cardiff Oncology Outlines Data From Discontinued Colorectal Cancer Trial, Stock Soars
Cardiff Oncology Inc (NASDAQ:CRDF) provided a clinical update on the first release of data from its ONSEMBLE trial of onvansertib in combination with FOLFIRI/bev in patients with second-line RAS-mutated metastatic colorectal cancer (mCRC).
加的夫腫瘤公司（納斯達克股票代碼：CRDF）提供了其在二線RAS突變轉移性結直腸癌（mCRC）患者中使用onvansertib聯合Folfiri/BEV的ONSEMBLE試驗首次發佈的數據的臨床最新情況。
Although the Phase 2 ONSEMBLE trial was discontinued as part of the company's shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms before closing the trial to new enrollment.
儘管作爲公司向一線mCRC計劃轉變的一部分，ONSEMBLE的2期試驗已經終止，但在結束對新入組的試驗之前，它在三個組中隨機招收了23名患者。
The 23 enrolled patients continued treatment per protocol. The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company's earlier Phase 1b/2 KRAS-mutated mCRC trial.
23名入組患者根據方案繼續接受治療。臨床數據重複了該公司早些時候在1b/2期KRAS突變的mCRC試驗中看到的onvansertib對純性純素患者的療效發現。
In August 2023, Cardiff Oncology discontinued enrollment in the second-line ONSEMBLE trial to focus on its new lead program in first-line RAS-mutated mCRC.
2023年8月，加的夫腫瘤學停止了二線ONSEMBLE試驗的入組，將重點放在其一線RAS突變mCRC的新主導項目上。
This decision was driven by the fact that both trials essentially test the same clinical hypothesis, the importance of deploying the company's capital efficiently, and the FDA's suggestion that Cardiff Oncology consider focusing on the first-line RAS-mutated mCRC setting given the lack of any new therapies approved in this large cancer indication in the last 20 years.
之所以做出這一決定，是因爲這兩項試驗基本上都檢驗了相同的臨床假設、有效部署公司資本的重要性，以及鑑於過去20年來該大型癌症適應症中沒有任何新療法獲得批准，美國食品藥品管理局建議加的夫腫瘤學考慮將重點放在Ras突變的一線mCRC環境上。
At the time enrollment was discontinued, the ONSEMBLE trial had randomized 23 patients across three arms, including a control arm of the standard of care (SoC) FOLFIRI+bev, an experimental arm with onvansertib (20mg dose) added to SoC FOLFIRI+bev, and an experimental arm with onvansertib (30mg dose) added to SoC FOLFIRI+bev.
在停止入組時，ONSEMBLE試驗已將23名患者隨機分爲三個組，包括標準護理（SoC）Folfiri+BEV的對照組，在SoC Folfiri+BEV中添加onvansertib（20mg劑量）的實驗組，以及將onvansertib（30mg劑量）添加到SoC Folfiri+BEV的實驗組。
Onvansertib (all doses) + SoC in 15 patients showed Objective Response Rates of 50% (2 of 4) in Bev naïve patients, 0% (0 of 11) in Bev exposed patients, and in all patients 13% (2 of 15).
在15名患者中，Onvansertib（所有劑量）+ SoC 顯示，Bev天真患者的客觀反應率爲50％（4箇中的2個），暴露於Bev的患者的客觀反應率爲0％（11箇中的0個），所有患者的客觀反應率爲13％（15箇中的2個）。
No clinical responses were observed in patients who received standard of care with FOLFIRI/bev or were previously exposed to Bev.
在接受Folfiri/BEV標準護理或之前接觸過Bev的患者中，未觀察到臨床反應。
The combination of onvansertib with SoC FOLFIRI/bev was well-tolerated, and no major/unexpected toxicities were seen.
onvansertib與SoC Folfiri/BEV的組合耐受性良好，未發現重大/意想不到的毒性。
Cardiff Oncology had approximately $75 million in cash, cash equivalents, and short-term investments at the end of 2023, and it is expected to provide a cash runway into the third quarter of 2025.
截至2023年底，加的夫腫瘤學擁有約7500萬美元的現金、現金等價物和短期投資，預計將在2025年第三季度提供現金流。
Price Action: CRDF shares are up 37.60% at $2.43 on the last check Friday.
價格走勢：週五的最後一次支票中，CRDF股價上漲37.60％，至2.43美元。
Image by PDPics from Pixabay
圖片由來自 Pixabay 的 PDPics