SynCore Biotechnology Co (杏國新藥) yesterday said that it has begun phase 3 clinical trial of its experimental drug for pancreatic cancer SB05PC in China.
Clinical trials of the drug in Taiwan and six other countries last year showed no statistical significance, it said.
Although there was no statistical significance, the company said it would tweak its development of the new drug based on the trial results.
The company yesterday gave SB05PC, which is designed to prolong patients’ lives, to its first patient in China, commencing its human test after receiving approval from China’s National Medical Products Administration to conduct the test in 2019.
SynCore should be able to recruit more participants smoothly in the latest clinical trial, as China has one of the highest number of people with pancreatic cancer, it said in a company statement.
However, SynCore did not reveal the protocols of its human tests in China, nor whether it would give the participants its SB05PC alone or give them SB05PC in combination with a chemotherapy medication gemcitabine as the firm did in its clinical trials in Taiwan and other countries.
The company would first give the drug to participants in the trial and, after collecting enough data, it would discuss the best protocol with Chinese regulators, it told the Taipei Times.
It would refer to its previous clinical trials, but it does not rule out any viable approaches, it added.
SynCore had applied to Chinese regulators to assign SB05PC as the first-line medicine for pancreatic cancer, while in other markets it hopes that SB05PC could be used as a second-line treatment — for people who do not respond well to the first-line medication, Folfirinox.
In SynCore’s previous test, participants either received SB05PC in combination with gemcitabine, or only gemcitabine in the control group, but the two groups showed no significant difference in overall survival time or disease control rate, corporate data showed.
The number of pancreatic cancer patients in China is expected to hit 150,000 by 2025, which would surpass a quarter of the total number of patients in the world, but few drugs had been approved in China to treat pancreatic cancer, SynCore said.
While several pharmaceutical companies have also been attempting to develop treatment, SynCore outpaced them as it has entered into the phase three test, with other comoanies still conducting phase one or two test, it said in the statement.
SynCore yesterday reported a net loss of NT$458 million for last year, or minus-NT$4.04 per share. Its board of directors decided not to distribute dividends this year, it said in filings to the Taipei Exchange.
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