SynCore Biotechnology Co’s (杏國新藥) new pancreatic cancer drug, SB05, has been approved by the Food and Drug Administration for further testing, and it is to carry out phase III clinical trials in conjunction with gemcitabine, the company said yesterday.
SB05 received the same approval from US authorities in April and the company is to continue to seek approval from Europe and other Asian markets, it said.
The 214-person study should be completed by 2020 to meet the company’s goal of commercialization by 2021, it said.
The study is designed as an alternative late-stage treatment for patients who have exhausted other first-line chemotherapy treatments such as Folfirinox, the company said.
SB05 has proven effective when used with gemcitabine, extending patients’ overall survival rate by 18 months, the company said, adding that the treatment has relatively few side effects and low levels of toxicity.
SB05 has also received orphan drug designation in Europe and the US, which expedites the review process, the company said.
The drug is made with its proprietary EndoTAG technology, an anti-tumor cationic liposome that employs positively charged liposomes embedded with paclitaxel, targeting negatively charged cancerous endothelial cells, the company said.
EndoTAG “envelopes” the drug to disrupt the flow of oxygen and nutrients to improve its ability to suppress tumor growth, it said.
Other projects in the company’s new drug pipeline include SB01, a head and neck cancer treatment; SB02, a gastric cancer treatment; and SB04, an eye drop for age-related macular degeneration.
In the pancreatic cancer segment, the company is competing against rivals such as GlycoNex Inc (台灣醣聯), Senhwa Biosciences Inc (生華生物科技) and Aslan Pharmaceuticals Ltd (亞獅康), according to findings by Yuanta Securities Investment Consulting Co (元大投顧).
SynCore shares yesterday gained 0.5 percent to close at NT$29.95 in Taipei trading.
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