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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 ·  06/26 20:03

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On June 25, 2024, Allarity Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced significant progress in its Phase 2 clinical trial for stenoparib, a treatment for advanced recurrent ovarian cancer. The trial has shown that multiple patients have been on treatment for over 30 weeks, demonstrating the drug's extended clinical benefit. This follows an earlier announcement in May 2024, where stenoparib was reported to have significant tumor shrinkage and long-term disease stability in heavily pre-treated patients. The company has decided to halt patient enrollment to focus on a follow-on trial aimed at accelerating stenoparib's path to regulatory approval. The trial's Principal Investigator, Kathleen N. Moore, MD, highlighted the need for continued development of next-generation PARP inhibitors like stenoparib...Show More
On June 25, 2024, Allarity Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced significant progress in its Phase 2 clinical trial for stenoparib, a treatment for advanced recurrent ovarian cancer. The trial has shown that multiple patients have been on treatment for over 30 weeks, demonstrating the drug's extended clinical benefit. This follows an earlier announcement in May 2024, where stenoparib was reported to have significant tumor shrinkage and long-term disease stability in heavily pre-treated patients. The company has decided to halt patient enrollment to focus on a follow-on trial aimed at accelerating stenoparib's path to regulatory approval. The trial's Principal Investigator, Kathleen N. Moore, MD, highlighted the need for continued development of next-generation PARP inhibitors like stenoparib. CEO Thomas Jensen emphasized the drug's favorable safety profile and its potential as a next-generation treatment option. The company plans to present detailed trial data at a high-level scientific conference, adhering to the common rules of such events. The PARP inhibitor market, which is expected to reach $22 billion by 2028, has seen significant interest in drugs with improved tolerability and safety profiles. Stenoparib, which also inhibits Tankyrase 1 and 2, is considered a differentiated therapeutic product due to its dual inhibitory activities and safety profile. Allarity Therapeutics uses its proprietary DRP® companion diagnostic to select patients likely to benefit from stenoparib, which has shown promise in increasing therapeutic benefit rates.
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。

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