Tag: approval

Race Oncology Limited (ASX:RAC) is an Australian pharmaceutical company focused on the development of its key drug, Zantrene, which is currently being studied for pre-clinical and clinical efficacy in several cancer indications. Zantrene is a highly targeted precision oncology agent…

Race Oncology Limited (“Race”) is pleased to announce it has received Research Governance Office (RGO) approval from the Calvary Mater Newcastle Hospital for its open label clinical trial of Zantrene® (bisantrene dihydrochloride) in patients with extramedullary Acute Myeloid Leukaemia (AML)…

6 April 2022 – Race Oncology Limited (“Race”) is pleased to announce it has receivedhuman ethics approval for its open label clinical trial of Zantrene® (bisantrenedihydrochloride) in patients with extramedullary Acute Myeloid Leukaemia (AML) or highrisk Myelodysplastic Syndrome (MDS). Before…

Race Oncology (“Race”) is pleased to announce that it has been issued a new patent (US 11,135,201) from the United States Patent and Trademarks Office (USPTO) for its cancer drug, Zantrene® (bisantrene dihydrochloride). This is Race’s fifth patent granted for…

Race Oncology is pleased to announce that it has received a letter from the FDA advising that Bisantrene has been granted Rare Paediatric Disease (RPD) designation for the treatment of childhood Acute Myeloid Leukaemia (AML). The RPD designation means Bisantrene has…

Race Oncology is pleased to announce that approval has been received from the Medicines and Healthcare products Regulatory Agency (MHRA) for importation and distribution of Bisantrene as an unlicensed medicine in the UK. The letter from the MHRA was received…

Race Oncology’s second Bisantrene patent has received “Notice of Allowance” in the US. Once ‘allowed’ in a jurisdiction, a patent can proceed to a ‘granted’ patent. The patent titled, “Compositions to Improve the Therapeutic Benefit of Bisantrene and Analogs and…