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Kintara Therapeutics Receives Orphan Drug Designation for VAL-083 for Treatment of Diffuse Intrinsic Pontine Glioma (DIPG)
SAN DIEGO, Dec. 15, 2022 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the
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[{"type":"text","content":"SAN DIEGO, Dec. 15, 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 it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for VAL-083 for the treatment of diffuse intrinsic pontine glioma (DIPG), a rare and highly-aggressive childhood brain cancer.\nThe FDA's ODD program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people. ODD provides the sponsor of the drug with development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.\n\"This is another important step for us in evaluating VAL-083 as a treatment for brain tumors in addition to our lead indication of glioblastoma,\" said Robert E. Hoffman, Kintara's President and CEO. \"We will continue with our clinical advancement of the drug candidate with our objective of delivering a much-needed new treatment that can benefit patients.\"\nABOUT KINTARALocated 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 Therapy for cutaneous metastatic breast cancer (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, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently advancing VAL-083 in the Global Coalition for Adaptive Research registrational Phase 2/3 clinical trial titled Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study to support the development and commercialization of VAL-083 in GBM.\nKintara also has a proprietary, late...