Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), an R&D biotechnology company focused on delivering innovative oncology and rare disease products to patients, is pleased to announce that it has received confirmation of a €2.6 million EU grant to be used to conduct a ground-breaking clinical study, GlioKIDS, designed to demonstrate the efficacy of MTX110 as a treatment for Diffuse Intrinsic Pontine Glioma ("DIPG"), a rare and fatal form of childhood brain cancer with an average life expectancy of 7 to 9 months.
The grant is under the EU EIC Accelerator SME Instrument and is part of the European Innovation Council (“EIC”) that supports top class innovators and small companies with funding opportunities to establish market-creating innovations that shape new markets and generate jobs, growth and higher standards of living. According to the EU, there are 6000 applications per year, of which 4 to 5% are selected.
The funds are subject to finalisation of the grant agreement currently being prepared with the EU, a process which is anticipated to conclude in early 2020, following which Midatech will look to start the European study, an open label trial of about 20 patients with a one-year treatment period. The grant covers 70% of the expected study costs, with the remainder covered by Midatech.
GlioKIDS will be the first ever clinical trial to use a fully implantable Convection Enhanced Delivery (“CED”) catheter system to allow chronic treatment of brain cancer. Based on pre-clinical research, DIPG tumours are exquisitely sensitive to the anti-cancer actions of MTX110, and CED administration of MTX110 produces concentrations of MTX110 at the tumour site that are more than 100,000 times higher than can be achieved with current treatments. To date there are no approved therapeutic treatments and hundreds of clinical trials have failed in this area.
Orphan Drug Status for this ultra-rare disease was granted for MTX110 in the US this year providing for a potentially more rapid approval process, assistance from regulatory agencies during drug development and the opportunity for market exclusivity following approval.
Commenting Craig Cook, CEO of Midatech, said: “Being selected by the EIC is a major validation of the innovation and value of our MTX110 proposition. These childhood brain tumours are devastating diseases with very limited treatment options and MTX110 has been formulated specifically to overcome the limitations of existing therapies and administration. We look forward to continuing our development of MTX110 as an effective therapy with the potential to make a substantial difference for patients based on its efficacy potential, demonstrated safety, and the ability to exploit novel and alternative routes of administration that provide a ‘direct to tumour’ platform for the broader application of MTX110, for childhood and adult brain cancers.”
Download PDF here