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Panbela Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced the initiation of a new clinical trial referred to as ASPIRE. The trial is a randomized, double-blind, placebo-controlled study in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. The trial will be conducted globally at approximately 93 sites in the United States, Europe, and Asia-Pacific. The ASPIRE trial commenced in early 2022, with full enrollment expected by the first quarter of 2025 and interim data analysis based on overall survival anticipated by mid-2024. The Independent Data Safety Monitoring Board has met twice, with no safety concerns reported, allowing the trial to continue without modification. As of January 25, 2024, the trial had exceeded 50% enrollment. Panbela's financials reflect...Show More
Panbela Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced the initiation of a new clinical trial referred to as ASPIRE. The trial is a randomized, double-blind, placebo-controlled study in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. The trial will be conducted globally at approximately 93 sites in the United States, Europe, and Asia-Pacific. The ASPIRE trial commenced in early 2022, with full enrollment expected by the first quarter of 2025 and interim data analysis based on overall survival anticipated by mid-2024. The Independent Data Safety Monitoring Board has met twice, with no safety concerns reported, allowing the trial to continue without modification. As of January 25, 2024, the trial had exceeded 50% enrollment. Panbela's financials reflect a net loss of $18.8 million for the nine months ended September 30, 2023, and negative cash flows from operating activities of approximately $21.8 million for the same period. The company has raised capital through public offerings and the sale of common stock to fund its operations. Panbela's future success depends on additional financing, successful clinical trials, regulatory approvals, and the commercialization of its product candidates.
临床阶段的生物制药公司Panbela Therapeutics, Inc. 宣布启动一项名为ASPIRE的新临床试验。该试验是一项随机、双盲、安慰剂对照的研究，联合吉西他滨和nab-紫杉醇治疗转移性胰腺癌。该试验将在全球范围内的美国、欧洲和亚太地区约93个地点进行。ASPIRE试验于2022年初开始，预计到2025年第一季度实现全员入组，基于总体存活率的中期数据分析预计将在2024年中期之前进行。独立数据安全监督委员会已经举行了两次会议，没有报告任何安全问题，这使试验得以继续进行，无需修改。截至2024年1月25日，该试验的注册人数已超过50％。Panbela的财务状况显示，截至2023年9月30日的九个月净亏损为1,880万美元，同期经营活动产生的负现金流约为2180万美元。该公司通过公开发行和出售普通股筹集资金，为其运营提供资金。Panbela未来的成功取决于额外的融资、成功的临床试验、监管部门的批准及其候选产品的商业化。
临床阶段的生物制药公司Panbela Therapeutics, Inc. 宣布启动一项名为ASPIRE的新临床试验。该试验是一项随机、双盲、安慰剂对照的研究，联合吉西他滨和nab-紫杉醇治疗转移性胰腺癌。该试验将在全球范围内的美国、欧洲和亚太地区约93个地点进行。ASPIRE试验于2022年初开始，预计到2025年第一季度实现全员入组，基于总体存活率的中期数据分析预计将在2024年中期之前进行。独立数据安全监督委员会已经举行了两次会议，没有报告任何安全问题，这使试验得以继续进行，无需修改。截至2024年1月25日，该试验的注册人数已超过50％。Panbela的财务状况显示，截至2023年9月30日的九个月净亏损为1,880万美元，同期经营活动产生的负现金流约为2180万美元。该公司通过公开发行和出售普通股筹集资金，为其运营提供资金。Panbela未来的成功取决于额外的融资、成功的临床试验、监管部门的批准及其候选产品的商业化。
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