Despite requests by government agencies, no manufacturer has so far developed a child-friendly preparation of 13-cis-retinoic acid (13-CRA), which is needed to improve children’s treatment and protect unborn children.
Now Nova Laboratories aims to develop a fully tested and licenced oral liquid preparation of the drug, which will be trialled in children’s cancer centres across the UK in 2016.
Despite requests by government agencies, no manufacturer has so far developed a child-friendly preparation of 13-cis-retinoic acid (13-CRA), which is needed to improve children’s treatment and protect unborn children.
Now Nova Laboratories aims to develop a fully tested and licenced oral liquid preparation of the drug, which will be trialled in children’s cancer centres across the UK in 2016.
Neuroblastoma is a rare and aggressive cancer that mostly affects children up to the age of five. Children are commonly treated with a combination of therapies including the drug, 13-CRA. The drug treatment improves children’s survival chances and is standard therapy for this disease worldwide.
At present the drug is only available as a capsule, and as few young children will take capsules, carers often have to administer it by first extracting liquid out of the capsule.
Studies show that this method of administration commonly results in children being given the wrong dose of drug, which increases risks of treatment failure and drug toxicity.
Plus, since 13-CRA can cause birth defects, pregnant women caring for a child with NBL risk accidently exposing their unborn babies when drawing up 13-CRA from capsules.
The project team consists of Dr Peter White, managing and technical director at Nova Laboratories, and clinical investigators at University Hospitals of Leicester, University of Leicester and University of Newcastle.
Dr White said: “We are honoured and delighted to have been awarded the funding from the Department of Health and Wellcome Trust, through the Health Innovation Challenge Fund. A liquid formulation of 13-CRA is urgently needed for this disease and will permit accurate dosing in young children and could potentially improve patient outcomes. This is also a good opportunity for us to work with academic and clinical experts to stimulate the creation of an innovative drug product to benefit patients in the NHS.”
