MM-398 is a novel nanoliposomal encapsulation of irinotecan sucrosofate. MM-398 is designed to optimize the delivery of irinotecan by extending the duration of circulation in the body and preferentially activating the drug within the tumor to achieve higher levels of the active cytotoxic, SN-38. MM-398 has been or is being evaluated in several clinical trials including a Phase 2 single agent study of MM-398 in metastatic pancreatic cancer, now in Phase 3, an ongoing Phase 2 study of MM-398 in combination with 5-FU and LV in patients with metastatic colorectal cancer, and a Phase 1 cross indication translational study. MM-398 is not approved for any indication by the FDA or any other regulatory agency. The salt form of the active ingredient within MM-398 liposomes was recently assigned the non-proprietary name - irinotecan sucrosofate, by the USAN (United States Adopted Name) council.
Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. Merrimack applies its systems biology-based approach to biomedical research throughout the research and development process. Merrimack currently has six oncology therapeutics in clinical development. 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. This Phase 2 was supported by PharmaEngine, Inc. (Taipei, Taiwan), who provided a research grant and supplied PEP02/MM-398 to conduct the trial.
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," "hope" and similar expressions. In this press release, Merrimack's forward-looking statements include statements about the potential for MM-398 to provide clinical benefit, the timing for completion of enrollment of clinical studies, and the timing of release of study results. 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, 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 August 8, 2013 and other reports Merrimack files with the SEC.
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