Candel Therapeutics Reports Positive Phase III Data with Stock Surge Amid Prostate Cancer Trial Success
Candel Therapeutics' Phase III trial for its oncolytic virus CAN-2409 involved 745 patients diagnosed with intermediate-to-high-risk localized prostate cancer[1][2]. The trial was structured so that two-thirds of these patients received CAN-2409 in combination with valacyclovir, along with standard external beam radiation therapy[2]. This study was conducted under the FDA's Special Protocol Assessment program, indicating that its results have the potential to support a regulatory application, with the expectation of a favorable submission possibly by mid-2025, and potential approval by 2026[1].
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What are the potential implications of CAN-2409's success in the Phase III trial for its application in cancers other than prostate cancer?
How does the FDA's Special Protocol Assessment influence the likelihood and timeline of regulatory approval for CAN-2409?
What were the specific factors that contributed to the success of the Phase III trial compared to previous Phase II trials?
In what ways did the combination of CAN-2409, valacyclovir, and standard radiation therapy enhance disease-free survival in prostate cancer patients?
How might the results of this Phase III trial impact the overall market positioning and strategic direction of Candel Therapeutics?