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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 05:03

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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,临床阶段生物制药公司Allarity Therapeutics公司宣布,治疗爱文思控股不育卵巢癌倒序症状的药物stenoparib在其二期临床试验中取得了重要进展。该试验表明,多名患者接受了超过30周的治疗,说明药物具有长期的临床益处。这是在2024年5月早些时候的一份声明之后的进一步宣布,该声明显示stenoparib在经过重度预处理的患者中具有显着的肿瘤缩小和长期疾病稳定性。该公司已决定停止患者招募,专注于一个旨在加速stenoparib通过监管审批的后续试验。试验的首席研究员凯瑟琳·N·穆尔医学博士强调了继续开发像stenoparib这样的下一代PARP抑制剂的需求...展开全部
2024年6月25日,临床阶段生物制药公司Allarity Therapeutics公司宣布,治疗爱文思控股不育卵巢癌倒序症状的药物stenoparib在其二期临床试验中取得了重要进展。该试验表明,多名患者接受了超过30周的治疗,说明药物具有长期的临床益处。这是在2024年5月早些时候的一份声明之后的进一步宣布,该声明显示stenoparib在经过重度预处理的患者中具有显着的肿瘤缩小和长期疾病稳定性。该公司已决定停止患者招募,专注于一个旨在加速stenoparib通过监管审批的后续试验。试验的首席研究员凯瑟琳·N·穆尔医学博士强调了继续开发像stenoparib这样的下一代PARP抑制剂的需求。首席执行官托马斯·詹森强调了该药物良好的安全性和其作为下一代治疗选择的潜力。该公司计划在高水平科学会议上展示详细的试验数据,遵守此类事件的常规规则。PARP抑制剂市场预计在2028年达到220亿美元,对具有更好的耐受性和安全性的药物产生了极大的兴趣。由于其双重抑制活性和安全性,也能抑制Tankyrase 1和2,stenoparib被认为是一种不同的治疗产品。Allarity Therapeutics使用其专有的DRP®伴侣诊断方法来选择可能从stenoparib中获益的患者,这已经显示出在增加治疗效果率方面有所作为。
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