Race Oncology Ltd (ASX:RAC) has successfully completed a series of preclinical animal and laboratory studies demonstrating RAC’s novel bisantrene formulation, RC220, prevents drug precipitation and vein inflammation or damage when infused into peripheral veins.
The studies completed – which involved in-vivo and in-vitro models – are accepted by regulators for assessing intravenous infusion safety.
The results are significant as the current form of bisantrene requires the use of invasive central venous catheter (a main line inserted near or into the patient’s heart) performed in a hospital setting.
Key step on path to clinic
“Given the creativity, hard work and capital we have invested into RC220, it is gratifying to see the formulation perform as designed, preventing bisantrene peripheral vein precipitation and phlebitis in industry standard preclinical models expected by regulators,” Race Oncology executive director Dr Pete Smith said.
“This is a key step on our path to bringing a superior version of bisantrene to the clinic for the benefit of a much larger number of patients with solid tumours and the clinicians who treat them.
“With RC220 also comes additional, robust intellectual property that adds significant commercial value to Race.”
RAC emphasises the better quality of life peripheral intravenous (IV) administration can provide for patients, offering a much lower risk with less lifestyle disruption compared to a central venous catheter, which represents a high risk of serious infection and the necessity of major hospital visits.
The company will use the data from these studies to support regulatory applications and patent filings.