SynCore Bio Doses First Patient In Phase III Trial for SB05 Pancreatic Cancer in South Korea

Taipei, Taiwan, 25 December 2018.
SynCore Biotechnology Co. (4192:TT) announces first patient in for Phase III trial in SB05 pancreatic cancer (SB05PC), South Korea.

SynCore Bio has enrolled its first patient in South Korea, following on the enrolment success in Taiwan. In September, 2018, the global Phase III clinical trial SB05PC received approval from Ministry of Food and Drug Safety (MFDS) alongside U.S., France, Hungary, South Korea, Russia, Israel and Taiwan. SB05 targets pancreatic cancer for second-line treatment in combination with gemcitabine after FOLFIRINOX first-line treatment failure.

Pancreatic cancer treatment is still an unmet medical need, with an expediential market of US$13 billion by 2021, according to Market Research. Phase II clinical trial data suggests that the overall survival rate of SB05PC in combination with Gemcitabine is 13.7 months. In addition, the side effects are very low which is important for patients’ quality of life.

In 2018, the death rate for pancreatic cancer in South Korea is 6,611 people, which is 7.9% of all cancer deaths and the fourth highest cancer death. SB05PC has received approval from the EMA, the Orphan Drug Designation and Breakthrough Therapy Designation from the FDA.

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