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news.US-based Merrimack Pharmaceuticals has enrolled first patient in its Phase I clinical trial of MM-398 (nanoliposomal irinotecan injection) in a highly concentrated formulation to treat patients with recurrent high grade glioma, a type of aggressive brain tumour with poor prognosis.
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University of California associate professor of Neurological Surgery and principal investigator of the study Dr Nicholas Butowski is sponsoring and conducting the Phase I trial and it is being supported by research grants from the National Institutes of Health (NIH) and Merrimack.
About 36 patients with recurrent high grade glioma will be enrolled in the dose-escalating, open label Phase I trial, which will assess the safety of highly concentrated MM-398 when administered by convection-enhanced drug delivery in patients with recurrent high grade glioma.
Merrimack vice-president of Discovery Daryl Drummond said: "There are few options for patients with recurrent high grade gliomas, as these types of aggressive brain tumours often grow back after surgery and radiotherapy.
"We have seen encouraging results administering this highly concentrated formulation of MM-398 in a veterinary study of canines diagnosed with spontaneous brain tumors, where MM-398 was shown to extend quality of life and survival, and we are pleased to support Dr Butowski’s research."
In the trial, MM-398 will be administered with gadoteridol, an MRI imaging agent to provide real time visualization of drug distribution in the brain, through a small catheter that allows for the drug to be injected directly into the brain tumour.
This method of delivery needs small injection volume and so the company has developed a highly concentrated formulation of MM-398.