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Allarity Therapeutics | 8-K: Current report

Allarity Therapeutics | 8-K: Current report

Allarity Therapeutics | 8-K:重大事件
美股SEC公告 ·  2024/06/26 20:03

牛牛AI助理已提取核心訊息

Allarity Therapeutics announced that multiple patients in its Phase 2 clinical trial of stenoparib for advanced recurrent ovarian cancer have maintained treatment for over 30 weeks. The dual PARP/Tankyrase inhibitor has demonstrated clear clinical benefits, including significant tumor shrinkage and long-term disease stability in heavily pre-treated patients with limited life expectancy.The trial utilizes Allarity's DRP companion diagnostic to select patients with higher likelihood of treatment benefit. The current protocol administers stenoparib twice daily (200mg morning, 400mg evening), modified from the previous once-daily 600mg dose. Notably, the drug shows a favorable safety profile compared to first-generation PARP inhibitors and chemotherapy alternatives.Based on these promising results, Allarity has halted patient enrollment to focus on developing a follow-on trial aimed at accelerating regulatory approval. The company plans to present the significant clinical data at an upcoming scientific conference. The PARP inhibitor market is projected to reach $22 billion by 2028, with increasing focus on developing treatments with improved tolerability and safety profiles.
Allarity Therapeutics announced that multiple patients in its Phase 2 clinical trial of stenoparib for advanced recurrent ovarian cancer have maintained treatment for over 30 weeks. The dual PARP/Tankyrase inhibitor has demonstrated clear clinical benefits, including significant tumor shrinkage and long-term disease stability in heavily pre-treated patients with limited life expectancy.The trial utilizes Allarity's DRP companion diagnostic to select patients with higher likelihood of treatment benefit. The current protocol administers stenoparib twice daily (200mg morning, 400mg evening), modified from the previous once-daily 600mg dose. Notably, the drug shows a favorable safety profile compared to first-generation PARP inhibitors and chemotherapy alternatives.Based on these promising results, Allarity has halted patient enrollment to focus on developing a follow-on trial aimed at accelerating regulatory approval. The company plans to present the significant clinical data at an upcoming scientific conference. The PARP inhibitor market is projected to reach $22 billion by 2028, with increasing focus on developing treatments with improved tolerability and safety profiles.
2024年6月25日,臨床階段生物製藥公司Allarity Therapeutics, Inc.宣佈,stenoparib的2期臨床試驗在治療晚期複發性卵巢癌方面取得了重大進展。該試驗表明,多名患者已經接受治療超過30周,證明了該藥物的長期臨床效益。此前的2024年5月,stenoparib被報道已在經過重度預處理的患者中具有顯著的腫瘤縮小和長期疾病穩定性。公司決定停止招募患者,專注於旨在加速stenoparib通往監管批准的後續試驗。該試驗的首席研究員Kathleen N. Moore, MD強調了繼續開發像stenoparib這樣的下一代PARP抑制劑的必要性。首席執行官Thomas Je...展開全部
2024年6月25日,臨床階段生物製藥公司Allarity Therapeutics, Inc.宣佈,stenoparib的2期臨床試驗在治療晚期複發性卵巢癌方面取得了重大進展。該試驗表明,多名患者已經接受治療超過30周,證明了該藥物的長期臨床效益。此前的2024年5月,stenoparib被報道已在經過重度預處理的患者中具有顯著的腫瘤縮小和長期疾病穩定性。公司決定停止招募患者,專注於旨在加速stenoparib通往監管批准的後續試驗。該試驗的首席研究員Kathleen N. Moore, MD強調了繼續開發像stenoparib這樣的下一代PARP抑制劑的必要性。首席執行官Thomas Jensen強調了該藥物良好的安全性以及作爲下一代治療選擇的潛力。該公司計劃在一個高層次的科學會議上介紹詳細的試驗數據,並遵守此類活動的常規規定。預計到2028年,預計PARP抑制劑市場將達到220億美元,並且對具有改進的耐受性和安全性的藥物產生了極大的興趣。由於其雙重抑制活性和安全性優勢,還抑制Tankyrase 1和2,stenoparib被認爲是一種與衆不同的治療產品。Allarity Therapeutics使用其專有的DRP®同伴診斷方法,選擇可能從stenoparib中獲益的患者,該藥物在提高治療受益率方面顯示出有希望的跡象。

譯文內容由第三人軟體翻譯。


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