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. Forward-Looking Statement To the extent that statements contained in this press release are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include any statements about Merrimack's strategy, future operations, future financial position and future expectations and plans and prospects for Merrimack, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. In this press release, Merrimack's forward-looking statements include statements about the potential effectiveness of its drug candidates in new indications, the safety and tolerability of its drug candidates and its ability to translate clinical and pre-clinical data into future clinical success. Such forward-looking statements involve substantial risks and uncertainties that could cause Merrimack's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, development progress of Merrimack's companion diagnostics and other matters that could affect the availability or commercial potential of Merrimack's drug candidates or companion diagnostics. Merrimack undertakes no obligation to update or revise any forward-looking statements. Forward-looking statements should not be relied upon as representing Merrimack's views as of any date subsequent to the date hereof. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Merrimack's business in general, see the "Risk Factors" section of Merrimack's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 14, 2012 and other reports Merrimack files with the SEC.
CONTACT: Kathleen Petrozzelli Gallagher, Merrimack, 617-441-1043, firstname.lastname@example.org Liz Bryan, Spectrum, 202-955-6222, email@example.com