Merrimack initiated a pivotal Phase 3 clinical trial of MM-398 for the treatment of patients with metastatic pancreatic cancer who have previously failed treatment with gemcitabine. The trial, called NAPOLI-1 (NAnoliPOsomaL Irinotecan), is a global, randomized, open label Phase 3 study. NAPOLI-1 calls for a total enrollment of 405 patients equally randomized across the three arms: MM-398 as a monotherapy and MM-398 in combination with 5-FU/LV, compared with the shared control arm of 5-FU/LV. Merrimack believes that MM-398 has potential uses in a number of other indications, including colorectal cancer, lung cancer, gastric cancer and glioma. In addition to NAPOLI-1, there are ongoing Phase 1 and Phase 2 clinical trials of MM-398 in glioma and colorectal cancer. MM-398 has been tested in several clinical trials, including a Phase 2 single agent study of MM-398 in metastatic pancreatic cancer and an ongoing Phase 2 study of MM-398 in combination with 5-FU and leucovorin in patients with metastatic colorectal cancer.
In July 2011, the U.S. Food and Drug Administration (FDA) granted MM-398 orphan drug designation for the treatment of pancreatic cancer. Merrimack holds the development and commercialization rights to MM-398 worldwide, with the exception of Taiwan. Merrimack has licensed the Taiwanese commercialization rights to PharmaEngine, Inc. (Taipei), which conducted previous studies of MM-398 under the designation PEP02.
About Merrimack Pharmaceuticals, Inc.
Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has six targeted therapeutic oncology candidates in clinical development.
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CONTACT: Kathleen Petrozzelli Gallagher, Merrimack, 617-441-1043,
Liz Bryan, Spectrum, 202-955-6222, firstname.lastname@example.org