PharmaEngine News Release PharmaEngine Announces Presentations of MM-398 (PEP02) Phase 3 NAPOLI-1 Study and Phase 2 PEPCOL study at the 2015 ASCO Gastrointestinal Cancers Symposium Taipei, Taiwan, January 08, 2015 -- PharmaEngine, Inc. today announced that clinical data from the phase 3 NAPOLI-1 study of MM-398 (PEP02, nanoliposomal irinotecan injection) in metastatic pancreatic cancer and the phase 2 PEPCOL study in unresectable metastatic colorectal cancer will be presented at the American Society of Clinical Oncology 2015 Gastrointestinal Cancers Symposium (ASCO GI), January 15-17, 2015 at Moscone West Building in San Francisco, CA. In addition to the poster presentation, the phase 3 data will be orally presented by Li-Tzong Chen, M.D., Ph.D., Director, Investigator and Attending Physician at the National Institute of Cancer Research in Taiwan. The following details are the information of the oral and poster presentations: Title: Expanded analyses of NAPOLI-1: Phase 3 study of MM-398 (nal-IRI), with or without fluorouracil and leucovorin, versus 5-fluorouracil and leucovorin, in metastatic pancreatic cancer (mPAC) patients previously treated with gemcitabine-based therapy Oral Abstract Session: Cancers Of The Pancreas, Small Bowel, And Hepatobiliary Tract Abstract: #234, Board A5 Date/Time: Friday, January 16, 2015, 2:00 p.m. PT Poster Viewing Date/Time: Friday, January 16, 2015, 12:00-2:00 p.m. and 5:30-7:00 p.m. PT Title: PEPCOL: A randomized noncomparative phase II study of PEP02 (MM-398) or irinotecan in combination with leucovorin and 5-fluorouracil as second-line therapy in patients with unresectable metastatic colorectal cancer – A GERCOR study Poster Session: General Poster Session C and Trials in Progress Session C: Cancers Of The Colon, Rectum, And Anus Abstract: #751, Board E41 Poster Viewing Date/Time: Saturday, January 17, 2015, 7:00-7:55 a.m. and 12:00-2:00 p.m. PT About MM-398 (PEP02) MM-398 (PEP02, nanoliposomal irinotecan injection or nal-IRI) is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. In May 2011, PharmaEngine and Merrimack executed an exclusive license agreement. Under the terms of the agreement, PharmaEngine granted back Merrimack the rights to develop, manufacture, and commercialize PEP02 (designated as MM-398 by Merrimack) in Asia and Europe, and retained the same rights in Taiwan. In 2011, MM-398 has separately received orphan drug designation from the US FDA and European Medicines Agency (EMA) for the treatment of pancreatic cancer. In addition, MM-398 received Fast Track Designation for postgemcitabine metastatic pancreatic cancer from the US FDA in November 2014. PharmaEngine News Release About PharmaEngine, Inc. (TWO: 4162) PharmaEngine is a biopharmaceutical company established in Taipei, Taiwan in 2003. PharmaEngine focuses on the development of new drugs for the treatment of cancer and Asian prevalent diseases. PharmaEngine has three projects: one in pre-NDA stage (PEP02 / MM-398); one in pivotal trial, phase II/III registration trial (PEP503 / NBTXR3); and one in drug discovery (PEP06). For further information, please visit PharmaEngine’s website at http://www.pharmaengine.com. Contact Peter Wu, Director, Corporate Development Telephone No.: (+886)-2-2515-8228, ext. 300 Mobile phone No.: (+886)-935-154-559 Email: [email protected]
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