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news.The US Food and Drug Administration (FDA) has approved Midatech Pharma’s investigational new drug (IND) application to carry out a study of an investigational nano-inclusion product, MTX110, to treat fatal childhood brain cancer DIPG.
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DIPG disease is mostly observed in young children with a median survival of nine months.
Midatech Pharma said the approval of MTX110 trial is a big step towards development of treatment for this cancer, as there are no current approved treatments.
MTX110 has been selected based on both independent and Midatech research, which identified the active ingredient as the most potent compound of 83 tested against human DIPG tumour cells.
The compound was brought from initial formulation stage at the end of 2015 to the clinical trial in this year.
Midatech will carry out the trial at major treatment centres in UCSF in San Francisco, as well as the Memorial Sloan Kettering Cancer Center in New York.
The study is expected to be completed by the end of 2019.
Midatech Pharma CEO Jim Philips said: "Midatech has worked hard to rapidly develop and bring MTX110 through to this clinical trial. We have seen compelling data for MTX110 in pre-clinical models and we are excited by the potential for this to be evidenced in patients as well.
“We are looking forward to potentially demonstrating the drug's efficacy in this disease, and making a difference to the children suffering from this devastating cancer for which palliative options are currently the only choice.
“MTX110 is one of our three priority programmes and we look forward to reporting back on progress in due course."