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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

Merrimack Pharmaceuticals and PharmaEngine Report Positive Phase III Results for MM-398 in Pancreatic Cancer

PharmaEngine and its partner Merrimack Pharmaceuticals have presented additional analyses from a global, randomised, open-label Phase III (NAPOLI-1) trial investigating the safety and efficacy of MM-398 (liposome irinotecan injection) in metastatic pancreatic cancer. The analyses of the trial lend further support to the positive top-line data that were presented in 2014 demonstrating a statistical increase in overall survival (OS) following treatment with MM-398 and 5-fluorouracil and leucovorin (5-FU/LV), with a hazard ratio of 0.67 (p=0.01) and a median OS of 6.1 months, compared with 4.2 months with 5-FU/LV alone. In the expanded analyses, the OS for MM-398 hazard ratio was 0.57 (p=0.0009) in the stratified analysis that accounts for pre-specified prognostic factors, while the analysis of the per protocol population, or those patients who received 80% of protocol-defined dose and remained on treatment for at least six weeks demonstrated more statistical improvement in median OS (8.9 months) compared with the control arm (5.1 months; p=0.0018). In addition, the trial revealed significant improvements in progression-free survival, objective response rate, and CA19-9 tumour market response following treatment with MM-398 compared with the control arm. The data were presented at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology on 16 January 2015.

PharmaEngine Announces Phase 2 PEPCOL Study

PharmaEngine Inc. announced that the data from the randomized non-comparative phase 2 PEPCOL study of PEP02 (MM-398, liposome irinotecan injection) in unresectable metastatic colorectal cancer (mCRC) were presented as a poster at the American Society of Clinical Oncology 2015 Gastrointestinal Cancers Symposium (ASCO GI) on January 17, 2015. This PEPCOL study was sponsored by Groupe Cooprateur Multidisciplinaire en Oncologie (GERCOR) and co-sponsored by PharmaEngine and PharmaEngines partner, Merrimack Pharmaceuticals Inc. The PEPCOL study evaluated the efficacy and safety of PEP02 (MM-398) in combination with 5-FU/LV (FUPEP regimen) or irinotecan plus 5-FU/LV (FOLFIRI regimens: FOLFIRI-1 or modified FOLFIRI-3) as a second-line therapy in patients with mCRC. The primary endpoint was the objective response rate (ORR). Fifty-five patients were randomized (FUPEP, n=28; FOLFIRI, n=27). In the intent to treat population, the ORR of the FUPEP regimen was 14% (4/28), which compared favorably with FOLFIRI-1 (0%, 0/10) and was comparable to the modified FOLFIRI-3 regimen (18%, 3/17). Most common grade 3-4 adverse events reported in the respective FUPEP and the FOLFIRI arms were neutropenia (11% vs. 30%) and diarrhea (21% vs. 33%), which were numerically lower in FUPEP arm than in FOLFIRI arm; other aspects of the safety profiles were similar between the two arms. PEPCOL is a randomized non-comparative phase 2 study in patients who were previously treated with oxaliplatin-containing first-line regimen. Patients were randomly assigned to FUPEP (PEP02 80 mg/m² d1, folinic acid (FA) 400 mg/m² d1, 5-FU 2,400 mg/m² d1-2) or FOLFIRI (FOLFIRI-1: irinotecan 180 mg/m² d1, FA 400 mg/m² d1, 5-FU bolus 400 mg/m² d1, 5-FU infusion 2,400 mg/m² d1-2; or modified FOLFIRI-3: irinotecan 90 mg/m² d1 and 3, FA 400 mg/m² d1, 5-FU infusion 2,400 mg/m² d1-2). Bevacizumab q2w (5 mg/kg) was allowed in both arms as of June 2012. The primary endpoint was the objective response rate (ORR). The study was conducted at six sites in France.

PharmaEngine Inc. and Nanobiotix SA Strengthen Collaboration for a Global Pivotal Trial of NBTXR3 in Soft Tissue Sarcoma

PharmaEngine Inc. and Nanobiotix SA announced that the companies had strengthened their collaboration by jointly conducting a global pivotal trial of NBTXR3 in soft tissue sarcoma (STS) in Europe and Asia. Nanobiotix expects recruitment of the first patient in Europe by the end of 2014. In conjunction with the accelerated clinical development, PharmaEngine will make a milestone payment of $1 million to Nanobiotix. In August 2012, PharmaEngine licensed the development and commercialization rights of NBTXR3 (designated as PEP503 by PharmaEngine) in Asia-Pacific region from Nanobiotix. Nanobiotix reported results of a pilot study of STS in mid-2014. Twenty patients were enrolled and received a single intratumoral injection of NBTXR3 (PEP503), at escalating volumes, followed by five weekly sessions of standard radiotherapy (50 Gy), after which the patients underwent surgical resection. The treatment regimen was well tolerated and showed promising signs of anti-tumor activity. The positive results of the study were presented by Nanobiotix at the American Society of Clinical Oncology Annual Meeting in June 2014.


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