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Kintara Therapeutics’ VAL-083 Receives the US FDA’s Orphan Drug Designation for the Treatment of Diffuse Intrinsic Pontine Glioma

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Kintara Therapeutics’ VAL-083 Receives the US FDA’s Orphan Drug Designation for the Treatment of Diffuse Intrinsic Pontine Glioma

Shots:

  • The US FDA has granted ODD to VAL-083 for the treatment of diffuse intrinsic pontine glioma
  • In the US clinical trials (sponsored by NCI). VAL-083 showed clinical activity against a range of cancers, incl. CNS, ovarian, and other solid tumors. The company continues to advance the therapy in the P-II/III clinical trial for glioblastoma
  • Kintara develops two late-stage P-III programs i.e., VAL-083 for glioblastoma and REM-001 for cutaneous metastatic breast cancer (CMBC). REM-001 showed a clinical efficacy with 80% complete responses of CMBC evaluable lesions along with a robust safety database of ~1100 patients across multiple indications

Ref: PRNewswire Image: Kintara

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