Paediatric Investigation Plan approved by MHRA
pharmafile | August 24, 2022 | News story | Research and Development |
Northwest Biotherapeutics has announced the approval from the MHRA of the company’s Paediatric Investigation Plan (PIP). The development, regulatory review, and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients.
Northwest Biotherapeutics is a biotech company developing DCVax personalised immune therapies for solid cancers. The company’s approved PIP includes two clinical trials, one of which is for newly diagnosed paediatric high-grade glioma (HGG), the other for recurrent paediatric HGG.
In each of the two paediatric trials, 24 patients will be treated with DCVax-L on the same treatment schedule as in the company’s Phase III trial in adult glioblastoma patients. The primary endpoint for each of the two trials will be overall survival. This will be determined by comparing the survival of DCVax-L treated patients to the matched contemporaneous external controls.
The external controls will be identified using the same methodology used to pre-specify the external controls in the Statistical Analysis Plan for Northwest Biotherapeutics’ Phase III trial in adult patients.
Under UK law, when a new medicine is developed for adult patients, that medicine must also be tested for potential application to paediatric patients. The sponsor must develop an overall plan to select the specific form or stage of the disease to be treated, to adapt the dosing and administration of the medicine for paediatric physiology, and to evaluate the safety and efficacy of the medicine in paediatric patients.
Further, the plan must include not only general focus areas, aims, and approaches. It must also include the full design of the specific clinical trials to be carried out, including all aspects required for clinical trial approvals. This includes the patient population, eligibility criteria, stage of disease, treatment regimen, trial design, and endpoints.
Northwest Biotherapeutics worked with expert consultants for months to develop a PIP tailored for application of DCVax-L to paediatric cases of HGG.
Ana Ovey
