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PharmaEngine Inc. announced today that together with PharmaEngine’s partner Merrimack Pharmaceuticals Inc. (NASDAQ: MACK) we reach the goal of patient enrollment in the global phase 3 metastatic pancreatic cancer study of PEP02 (MM-398). The total target number of patient enrollment is 405. The first patient received the first dose of MM-398 in January 2012.
Patients enrolled in this global open label phase 3 metastatic pancreatic cancer study referred to as NAPOLI-1 were 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 Global Principal Investigator is Dan von Hoff M.D. F.A.C.P. (TGen University of Arizona Mayo Clinic and Scottsdale Healthcare) and Taiwan’s Principal Investigator is Professor Li-Tzong Chen at National Institute of Cancer Research National Health Research Institutes Tainan Taiwan.
“We are very pleased to have achieved the patient enrollment goal earlier than expected and appreciate greatly the commitment and the efficiency of the Merrimack project team to plan and execute this study successfully in about 100 sites all over the world” said C. Grace Yeh Ph.D. President and Chief Executive Officer of PharmaEngine. “Moreover we are thankful for the contribution of Taiwan’s Principal Investigator Professor Li-Tzong Chen the investigators and their patients in Taiwan. I hope that PEP02 can provide benefits to the pancreatic cancer patients who become refractory to the gemcitabine-containing regimen in the near future.”
About Pancreatic Cancer
According to the information from the Ministry of Health and Welfare Taiwan in 2012 pancreatic cancer is the eighth leading cause of cancer deaths in Taiwan and about 1500 people die of pancreatic cancer every year. Metastatic pancreatic cancer is almost uniformly fatal with an overall survival rate of approximately 5 percent at 5 years worldwide. The drug used for the first-line therapy of the pancreatic cancer is gemcitabine. However the treatment effect of gemcitabine is limited in terms of extending the survival period and improving the quality of life. The patients with metastatic pancreatic cancer who failed gemcitabine treatment have no second-line or third-line standard therapies approved by the regulatory authorities.
About PEP02
PEP02 (Nanoliposomal irinotecan sucrosofate) is a novel stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. 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 US FDA and 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 Council.
About PharmaEngine Inc.
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; the second is PEP503 licensed from Nanobiotix SA (Paris France) in two phase I clinical trials in France; and the third is a research collaboration of new chemical entities with Guangzhou BeBetter Medicine Technology Co. Ltd. (Guangzhou China).
