Studies of Nanoliposomal Irinotecan (PEP02, MM-398) in Late Stage Pancreatic Cancer and Gastric Cancer Published in British Journal of Cancer and Annals of Oncology
PharmaEngine, Inc. (TWO:4162) announced today that the British Journal of Cancer has published the paper “A Multinational Phase 2 Study of Nanoliposomal Irinotecan Sucrosofate (PEP02, MM-398) for Patients with Gemcitabine-Refractory Metastatic Pancreatic Cancer” (2013: 109 (4): 920-925) this August, and the Annals of Oncology has published the paper “A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma“ (2013: 24 (6): 1567-1573) this June. The key results of these two studies were presented at the ASCO 2011 Gastrointestinal Cancers Symposium and ASCO 2011 Annual Meeting.
“We are very pleased to see that these two reputable international oncology journals accepted to publish the phase II results of these two PEP02 studies indicating that the quality of our multinational studies has been well recognized,” said C. Grace Yeh, Ph.D., President and Chief Executive Officer of PharmaEngine. “We are grateful to the contribution of the participating patients and the efforts from all the investigators and their teams who assisted us in completing these two important clinical trials.”
A global open label, randomized phase 3 metastatic pancreatic cancer study, referred to as NAPOLI-1, is being conducted by PharmaEngine’s partner, Merrimack Pharmaceuticals, Inc. (Cambridge, MA, USA). The total enrollment of approximately 405 patients randomized equally 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. The primary endpoint of this study is overall survival. The study sites include North America, South America, Europe, Australia and Asia (including Taiwan). The patient enrollment is expected to complete in the third quarter of this year.
About PEP02 (MM-398)
PEP02 (Nanoliposomal Irinotecan Sucrosofate) is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. In 2003, PharmaEngine licensed the exclusive rights to develop and commercialize PEP02 from Hermes BioSciences, Inc. (acquired by Merrimack in 2009). In May 2011, PharmaEngine grants back Merrimack the rights to develop, manufacture, and commercialize PEP02 in Asia and Europe, and retains its rights to PEP02 in Taiwan. MM-398 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2011 for the treatment of pancreatic cancer. Recently the salt form of the active ingredient inside the MM-398 liposomes was assigned the non-proprietary name - irinotecan sucrosofate, by the USAN (United States Adopted Name) Council.
About PharmaEngine, Inc. (TWO: 4162)
PharmaEngine, Inc. is a biopharmaceutical company established in Taipei, Taiwan in 2003. PharmaEngine adopts the business model of “no research, development only” and focuses on the development of new drugs for the treatment of cancer and Asian prevalent diseases. There are three ongoing projects: the first is PEP02 in a global phase III study for the treatment of metastatic pancreatic cancer; the second is PEP503 (crystalline hafnium oxide, aka NBTXR3) which was licensed from Nanobiotix, Inc. (Paris, France), is in two phase I clinical trials in France; and the third is a research collaboration of developing new chemical entities to predefined oncology targets with Guangzhou BeBetter Medicine Technology, Co., Ltd. (Guangzhou, China). For further information, please visit the Company’s website at http://www.pharmaengine.com.
Peter Wu, (+886)-2-2515-8228, ext. 300
Associate Director, Corporate Development