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Kintara Therapeutics Receives Study May Proceed Letter from the FDA for REM-001 for Cutaneous Metastatic Breast Cancer
SAN DIEGO, Aug. 9, 2022 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the
About this update from Tuhura Biosciences, Inc.
[{"type":"text","content":"SAN DIEGO, Aug. 9, 2022 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) (\"Kintara\" or the \"Company\"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that it has received a Study May Proceed letter from the United States Food and Drug Administration (FDA) to begin its 15 patient study evaluating REM-001 Photodynamic Therapy (PDT) for the treatment of Cutaneous Metastatic Breast Cancer (CMBC). This study is intended to aid in the design of a planned phase 3 registrational study.\n\"The FDA's reactivation of our Investigational New Drug application for REM-001 is an important milestone for Kintara,\" stated Robert E. Hoffman, President and CEO of Kintara. \"This clinical study is part of a broad strategy designed to demonstrate proof of concept for our Photodynamic Therapy platform in CMBC, an area of unmet medical need, as well as across other cutaneous metastatic cancers.\"\nPDT is a treatment that uses light sensitive compounds, or photosensitizers, that, when exposed to specific wavelengths of light, act as a catalyst to produce a form of oxygen that induces local tumor cell death. The planned clinical study is expected to enroll 15 patients with CMBC that is refractory or not eligible for radiotherapy or surgery. The study will evaluate cutaneous tumor response using standardized and calibrated 3D digital photography.\n\"We're excited to further explore the potential benefits of this second-generation photosensitizer, particularly given the unmet need of CMBC,\" added Dr. Mario E. Lacouture, Professor and Director of the Oncodermatology Program in the Dermatology Service Department of Medicine at Memorial Sloan Kettering Cancer Center and Chairman of Kintara's REM-001 Scientific Advisory Board.\nABOUT KINTARA\nLocated in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for glioblastoma (GBM) and REM-001 for CMBC.\nVAL-083 is a \"first-in-class\", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovar...