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Candel Therapeutics Completes Enrollment in Phase 3 Clinical Trial of CAN-2409 in Combination with Valacyclovir for the Treatment of Intermediate-High Risk Localized Prostate Cancer
NEEDHAM, Mass., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (“Candel”) (Nasdaq: CADL), a late clinical stage biopharmaceutical company
About this update from Candel Therapeutics, Inc.
[{"type":"text","content":"NEEDHAM, Mass., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (“Candel”) (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced that it has completed patient enrollment for its pivotal phase 3 study of CAN-2409 immunotherapy in patients with intermediate-high risk localized prostate cancer. This placebo-controlled, randomized clinical trial is evaluating CAN-2409 treatment in combination with valacyclovir added to upfront standard of care external beam radiation therapy for patients with localized prostate cancer compared to standard of care radiation therapy alone. “The combination of CAN-2409 with radiation therapy has been shown to create an immune stimulatory environment and is designed to activate the body's immune system to recognize and destroy cancer cells,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics. “There is a significant need in patients with localized, non-metastatic prostate cancer for novel therapies that will improve outcomes, while reducing the need for long-term androgen deprivation therapy with its associated side effects. We believe CAN-2409 could improve disease outcome in patients with prostate cancer, and we look forward to the results of this potentially registrational clinical trial in 2024.” The primary endpoint of the study is disease-free survival. Secondary endpoints include prostate cancer specific survival, overall survival, freedom from biochemical failure, patient reported health-related quality of life, and safety. For more information about this study, please visit: https://www.clinicaltrials.gov/ct2/show/NCT01436968 About CAN-2409 CAN-2409, Candel’s most advanced oncolytic viral immunotherapy product candidate, is a replication-deficient adenoviral gene construct encoding the herpes simplex virus thymidine kinase (HSV-tk) gene. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Intra-tumoral administration results in immunogenic cell death, followed by the release of tumor-specific neoantigens in the tumor microenvironment. At the same time, the adenoviral vector elicits a strong pro-inflammatory signal to the tumor microenvironment, creating the optimal conditions t...