CAMBRIDGE, Mass., June 17, 2014 (GLOBE NEWSWIRE) -- Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) today announced that results of the successful Phase 3 NAPOLI-1 study in metastatic pancreatic cancer will be communicated in an oral presentation at the European Society for Medical Oncology 16th World Congress on Gastrointestinal Cancer (ESMO GI) held from June 25th to 28th, 2014 at The International Convention Center of Barcelona in Barcelona, Spain. The data will be presented by Andrea Wang-Gillam, M.D., Ph.D., Assistant Professor of Medicine, Division of Oncology, Washington University School of Medicine, and the co-chair of the steering committee for the NAPOLI-1 study. The presentation will include additional efficacy and safety data from the three arm study of MM-398, a nanoliposomal irinotecan, in patients with metastatic pancreatic cancer who have received prior gemcitabine-based therapy.
"We are honored that the findings of MM-398 in combination with 5-fluorouracil and leucovorin in patients with post-gemcitabine pancreatic cancer from our NAPOLI-1 study have been accepted for oral presentation at ESMO GI," said Eliel Bayever, M.D., Vice President of Clinical Development at Merrimack. "We look forward to updating the medical oncology community with more comprehensive results of our study in treating this devastating disease. We are especially grateful to the patients, their families and caregivers, the investigators, and the research community for their commitment to this important study."
- NAPOLI-1: Randomized Phase 3 Study of MM-398 (nal-IRI), with or without 5-Fluorouracil and Leucovorin, versus 5-Fluorouracil and Leucovorin, in Metastatic Pancreatic Cancer Progressed on or Following Gemcitabine-based Therapy (Abstract #O-0003)
Session II: Cancer of the pancreas and bile ducts
Wednesday, June 25, 2014, 5:00 p.m. CEST
Poster viewing time: Thursday, June 26, 2014, 10:30-11:00 a.m. and 4:30-5:00 p.m. CEST
CCIB, Exhibit Hall
Merrimack to Host Conference Call
Merrimack will host an investor conference call and webcast at 8 a.m., Eastern Time, on Thursday, June 26, 2014 where Dr. Wang-Gillam will review the data presented at ESMO GI. Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 61076181.
A press release detailing the results presented at ESMO GI will be issued after the oral presentation on June 25. Slides accompanying the call and a listen-only webcast of the call can be accessed in the Investors section of Merrimack's website, http://investors.merrimackpharma.com, and a replay of the call will be archived there for six weeks.
NAPOLI-1 (NAnoliPOsomaL Irinotecan) is a randomized, open label Phase 3 study in patients with metastatic pancreatic cancer who received prior gemcitabine-based therapy. The study evaluated MM-398, a nanoliposomal encapsulation of the chemotherapeutic irinotecan, in two regimens: 80 mg/m2 combined with 5-FU and leucovorin every two weeks, or 120 mg/m2 as a monotherapy every three weeks. Each arm was compared to a control arm of 5-FU and leucovorin. A total of 417 patients were randomized across the three arms. Each MM-398 regimen was compared against the control arm for the primary endpoint of overall survival. Patients were enrolled at over 100 sites in North America, South America, Europe, Asia and Australia.
MM-398 (irinotecan liposome injection), also known as "nal-IRI," is a nanoliposomal encapsulation of the chemotherapeutic irinotecan. MM-398 has demonstrated extended circulation in the blood 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.
MM-398 is an investigational agent which is also currently being evaluated in an ongoing Phase 2 study in patients with metastatic colorectal cancer and Phase 1 studies in Ewing's sarcoma and glioma. An additional Phase 1 clinical trial is assessing a potential companion diagnostic for MM-398 in patients with multiple cancer types to determine which patients are most likely to benefit from treatment with the drug.
Under a 2011 agreement with PharmaEngine, Inc. (Taipei, Taiwan), Merrimack consolidated the worldwide development and commercialization rights to MM-398, with PharmaEngine, Inc. retaining commercialization rights in Taiwan.
MM-398 is not approved for any indication by the U.S. Food and Drug Administration (FDA) or any other regulatory agency. Both the FDA and the European Medicines Agency have granted MM-398 orphan drug designation in metastatic pancreatic cancer.
Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. Merrimack seeks to gain a deeper understanding of underlying cancer biology through its systems biology-based approach and develop new insights, therapeutics and diagnostics to improve outcomes for cancer patients. Merrimack currently has six oncology therapeutics in clinical development and three additional candidates in late stage preclinical development. For more information, please visit Merrimack's website at www.merrimackpharma.com.
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 and safety profile of MM-398 either alone or in combination. 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 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 May 6, 2014 and other reports Merrimack files with the SEC.
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