Date: 2014-11-06
Type of information: Initiation of patient enrollment
phase: 1
Announcement: initiation of patient enrollment
Company: Merrimack Pharmaceuticals (USA - MA)
Product: MM-398 (nanoliposomal irinotecan injection)
Action
mechanism: topoisomerase I inhibitor. MM-398 (irinotecan liposome injection) is a nanoliposomal encapsulation of the chemotherapeutic irinotecan. MM-398 has demonstrated extended circulation in comparison to free irinotecan in the clinical setting. The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promoting cell death. In 2014, Merrimack and Baxter International\'s biopharmaceutical business (BAX) entered into an exclusive licensing agreement to develop and commercialize MM-398 outside of the United States and Taiwan. PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize MM-398 in Taiwan.
Disease: recurrent high grade glioma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: 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. (NCT02022644).
Latest
news: * On November 6, 2014, Merrimack Pharmaceuticals 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. 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. 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.
