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Initiation of Phase 1 Clinical Study of MM-398
Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) today announced that the first patient has been enrolled in a Phase 1 clinical study of MM-398 (nanoliposomal irinotecan injection) in a highly concentrated formulation in patients with recurrent high grade glioma, a type of aggressive brain tumor with poor prognosis.
The study is being sponsored and conducted by Dr. Nicholas Butowski, M.D., Associate Professor of Neurological Surgery and Principal Investigator of the study at the University of California, San Francisco, and is supported by research grants from the National Institutes of Health and Merrimack.
“There are few options for patients with recurrent high grade gliomas, as these types of aggressive brain tumors often grow back after surgery and radiotherapy,” said Daryl Drummond, Vice President of Discovery at Merrimack. “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.”
The Phase 1, dose-escalating, open label study will assess the safety of highly concentrated MM-398 when administered by convection-enhanced drug delivery in patients with recurrent high grade glioma. In this study, MM-398 will be administered with gadoteridol, an MRI imaging agent to enable the 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 tumor – an approach called convection-enhanced drug delivery. Due to the small injection volume required for this method of delivery, a highly concentrated formulation of MM-398 was specifically developed by Merrimack. The study is being conducted at a single center at the University of California, San Francisco and will enroll up to 36 patients with recurrent high grade glioma. For more information visit www.clinicaltrials.gov (Identifier: NCT02022644).
“The blood-brain barrier is known to limit the effective delivery of anti-cancer therapies,” said Dr. Butowski. “By utilizing an imaging-guided, direct-injection technique to deliver MM-398, we hope to increase the cytotoxic effects of the drug on the tumor with less peripheral toxicity and fewer side effects. MM-398 is an excellent candidate for convection-enhanced delivery due to its nanoliposomal design, which may allow the drug to be stably deposited in the tumor, thereby prolonging exposure of the tumor to the drug.”
Additional preclinical research completed by collaborators at the University of California, San Francisco, has shown that convection-enhanced delivery of MM-398 results in tumor-drug concentrations up to 100-fold higher than concentrations achieved with standard intravenous injection, as well as significantly enhanced activity, which could translate into an increase in drug activation and duration of benefit in tumors cells.
MM-398, also known as “nal-IRI,” is an investigational drug candidate being developed for the treatment of patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. Merrimack is currently preparing a New Drug Application for MM-398.
