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pharmaengine inc (4162) Details

PharmaEngine, Inc., a biopharmaceutical company, is engaged in the development of drugs for the treatment of cancer and Asian prevalent diseases in Taiwan. The company develops, manufactures, and commercializes PEP02, a novel and stable nanoliposomal formulation of irinotecan, which has completed four Phase I studies and two Phase II studies for gastric and pancreatic cancers in Asia and Europe. It also develops PEP503, a crystalline hafnium oxide, which is in Phase I trial in France. PharmaEngine, Inc. has collaborations with Merrimack Pharmaceuticals, Inc.; Nanobiotix S.A.; and Guangzhou BeBetter Medicine Technology Co., Ltd. The company was founded in 2003 and is based in Taipei, Taiwan.

Founded in 2003

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pharmaengine inc (4162) Key Developments

PharmaEngine Inc., Annual General Meeting, Jun 11, 2014

PharmaEngine Inc., Annual General Meeting, Jun 11, 2014.

PharmaEngine Announces MM-398 (PEP02) in Combination with 5-FU/LV Met the Primary Endpoint of Overall Survival in Phase 3 Post-Gemcitabine Metastatic Pancreatic Cancer Study

PharmaEngine Inc. announced in conjunction with Merrimack Pharmaceuticals Inc. that the top line data of the global, open label, three arm randomized phase 3 metastatic pancreatic cancer (NAPOLI-1) study showed that the combination arm of MM-398 (irinotecan liposome injection) with 5-fluorouracil/leucovorin (5-FU/LV) achieved the primary endpoint of overall survival. Median overall survival on the combination arm was 6.1 months as compared to 4.2 months for the control arm of 5-FU/LV. The hazard ratio for overall survival, the trial's primary endpoint, was 0.67, which was statistically significant with a p-value of 0.012. A statistically significant difference in progression-free survival was also observed, and the safety profile of the combination arm was manageable. On the contrary, the monotherapy arm of MM-398 did not meet the primary endpoint as compared to the control arm of 5-FU/LV (4.9 months vs. 4.2 months, p-value = 0.942, hazard ratio = 0.99), and the patients in this monotherapy arm displayed higher levels of adverse events than those in the combination arm.

PharmaEngine Inc., Annual General Meeting, Jun 20, 2013

PharmaEngine Inc., Annual General Meeting, Jun 20, 2013.


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