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pharmaengine inc (4162) Details

PharmaEngine, Inc., a biopharmaceutical company, engages in the development of drugs for the treatment of cancer and Asian prevalent diseases in Taiwan. The company licenses in drug candidates ranging from preclinical to clinical stages. It is developing ONIVYDE, a liposome formulation of irinotecan for target indications, including pancreatic, gastric, colorectal, lung, and brain cancers; PEP503, a nanoparticle formulation of hafnium oxide for indications comprising head and neck cancer, oral cancer, colorectal cancer, esophageal cancer, brain cancer and hepatocellular carcinoma, etc.; and PEP06. 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

Nanobiotix' Partner, PharmaEngine Launches New NBTXR3 Clinical Trial in Head and Neck Cancers in Asia

NANOBIOTIX announced that its partner, PharmaEngine, has dosed its first patient in a new Phase I/II trial in patients with head and neck cancers patient receiving radiotherapy plus chemotherapy, this October. The trial is evaluating the optimal dose, safety and preliminary efficacy of Nanobiotix's lead product. PharmaEngine has broadened its development plan for NBTXR3 by launching this new trial in Asia targeting a new and larger head and neck cancer patient population. This follows the successful results from the European Phase I/II trial in patients with head and neck cancers presented in July 2016 by Nanobiotix demonstrating promising signs of tumor volume response and excellent signs of safety. NBTXR3 is now addressing a wide range of head and neck cancers patients. The study in Asia by PharmaEngine addresses patients receiving chemotherapy (cisplatin) plus radiotherapy whereas the study in Europe by Nanobiotix covers patients which are not eligible for chemotherapy plus radiotherapy and only receive radiotherapy. Head and neck cancers include cancers of the oral cavity, tongue and oropharynx. These cancers are a major concern for public health, with a high worldwide prevalence, particularly in Asia, where the patient population is expanding. This joint approach by Nanobiotix and PharmaEngine supports the preparation of a development plan for head and neck cancers registration studies with NBTXR3 potentially in Europe, in the US and in Asia. Nanobiotix will provide this in 2017.

PharmaEngine Inc. Announces Initiation of Phase 1b/2 Trial of PEP503 (NBTXR3) in Head and Neck Cancer

PharmaEngine Inc. announced that the first patient has been dosed in a phase 1b/2 trial of PEP503 (NBTXR3) of head and neck squamous cell carcinoma (HNSCC) at Keelung Chang Gung Memorial Hospital (Lovers Lake Branch) in Keelung, Taiwan. The Principal Investigator is Prof. Cheng-Hsu Wang, M.D. This prospective, open-label, single arm, non-randomized study (PEP503-HN-1002) of PEP503 in patients with HNSCC is being conducted in Taiwan by PharmaEngine. The primary objectives of this study are to determine the optimal dose, safety and preliminary efficacy of PEP503 through intra-tumor injection in combination with the standard treatment of concurrent chemoradiotherapy (CCRT) in SCC of oral cavity. A maximum of 42 patients may be enrolled in the phase 1b/2 study. The company's partner, Nanobiotix, is conducting a head and neck cancer study (NBTXR3 Study-102) of NBTXR3 (PEP503) in combination with radiation in elderly patients with SCC of oral cavity and oropharynx, who are not suitable for chemotherapy plus radiotherapy. These two studies will then identify the optimal doses for patients who can or cannot receive chemotherapy with radiotherapy plus NBTXR3 (PEP503).

PharmaEngine Announces Onivyde(R) Receives European Marketing Authorization for the Treatment of Metastatic Adenocarcinoma of the Pancreas Following Gemcitabine based Therapy

PharmaEngine Inc. announced that the European Commission (EC) has granted Shire plc a marketing authorization (MA) for ONIVYDE® (pegylated liposomal irinotecan hydrochloride trihydrate, nal-IRI) in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for the treatment of metastatic adenocarcinoma of the pancreas in patients who have progressed following gemcitabine based therapy. With this approval, Shire (formerly Baxalta) is authorized to market ONIVYDE in the 28 Member States of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. The approved dose of ONIVYDE in combination with 5-FU/LV is 80 mg/m2 irinotecan hydrochloride trihydrate every two weeks, which is also the FDA-approved dose regimen for pancreatic cancer in Taiwan. The approval follows on the positive opinions from the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Orphan Medicinal Products (COMP) and is based on data from the phase 3 NAPOLI-1 study. The NAPOLI-1 study demonstrated that ONIVYDE in combination with 5-FU/LV extended overall survival and progression-free survival and increased tumor response rate, without compromising quality of life as compared to 5-FU/LV alone in metastatic pancreatic cancer patients who have progressed after gemcitabine-based therapy. It is the first and only therapy approved by the US FDA and the European Medicines Agency (EMA) in this setting.


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