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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.
臨床階段的生物製藥公司Panbela Therapeutics, Inc. 宣佈啓動一項名爲ASPIRE的新臨床試驗。該試驗是一項隨機、雙盲、安慰劑對照的研究，聯合吉西他濱和nab-紫杉醇治療轉移性胰腺癌。該試驗將在全球範圍內的美國、歐洲和亞太地區約93個地點進行。ASPIRE試驗於2022年初開始，預計到2025年第一季度實現全員入組，基於總體存活率的中期數據分析預計將在2024年中期之前進行。獨立數據安全監督委員會已經舉行了兩次會議，沒有報告任何安全問題，這使試驗得以繼續進行，無需修改。截至2024年1月25日，該試驗的註冊人數已超過50％。Panbela的財務狀況顯示，截至2023年9月30日的九個月淨虧損爲1,880萬美元，同期經營活動產生的負現金流約爲2180萬美元。該公司通過公開發行和出售普通股籌集資金，爲其運營提供資金。Panbela未來的成功取決於額外的融資、成功的臨床試驗、監管部門的批准及其候選產品的商業化。
臨床階段的生物製藥公司Panbela Therapeutics, Inc. 宣佈啓動一項名爲ASPIRE的新臨床試驗。該試驗是一項隨機、雙盲、安慰劑對照的研究，聯合吉西他濱和nab-紫杉醇治療轉移性胰腺癌。該試驗將在全球範圍內的美國、歐洲和亞太地區約93個地點進行。ASPIRE試驗於2022年初開始，預計到2025年第一季度實現全員入組，基於總體存活率的中期數據分析預計將在2024年中期之前進行。獨立數據安全監督委員會已經舉行了兩次會議，沒有報告任何安全問題，這使試驗得以繼續進行，無需修改。截至2024年1月25日，該試驗的註冊人數已超過50％。Panbela的財務狀況顯示，截至2023年9月30日的九個月淨虧損爲1,880萬美元，同期經營活動產生的負現金流約爲2180萬美元。該公司通過公開發行和出售普通股籌集資金，爲其運營提供資金。Panbela未來的成功取決於額外的融資、成功的臨床試驗、監管部門的批准及其候選產品的商業化。
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