EpicentRx has commenced the Phase I PIRATE clinical trial of its lead small-molecule, RRx-001, in combination with irinotecan and temozolomide to treat recurrent or progressive malignant solid and central nervous system (CNS) tumours in paediatric patients. 

The trial will be carried out by EpicentRx in partnership with the Texas Children’s Cancer Center in Houston, US.

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Conceived and developed by the Texas Children’s Cancer Center doctors, the trial will analyse the safety and benefit of RRx-001 to treat paediatric CNS tumours.

It will have subjects aged one to 21 years with recurrent or progressive malignant primary brain or spinal cord tumours and solid tumours, excluding lymphomas.

Various prior trials validate the potential evidence that RRx-001 boosts chemotherapy delivery and uptake in tumours. 

In a Phase I G-FORCE trial and a Phase I/II BRAINSTORM trial of adult glioblastoma and brain metastases patients, respectively, RRx-001 was found to be safe and offered clinical benefit.

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EpicentRx CEO Tony Reid said: “We are excited to launch this study with RRx-001 and to establish its role as a potential treatment for paediatric CNS tumours. 

“As clinical trials in adult CNS tumours suggest that RRx-001 may provide benefit in a paediatric population, our collaboration with them is a testament to the commitment of this company to follow the data wherever it leads.”

In July 2020, the company signed a licensing agreement with SciClone Pharmaceuticals International for RRx-001 in Greater China.

An immunotherapeutic acting on the CD47 – SIRPα axis, RRx-001 repolarises tumour-associated macrophages as well as other immunosuppressive cells in the tumour microenvironment to an immunostimulatory phenotype.

It can also boost tumour blood flow to improve the supply of oxygen and delivery of the drug.