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Theragen dismisses allegations against its drug substance
  • By Lee Han-soo
  • Published 2018.05.18 11:09
  • Updated 2018.05.18 11:09
  • comments 0

Theragen Etex Bio Institute denied recent allegations regarding the problems with its clinical trial for TEW-7197, also known as Vactosertib, an immunotherapy agent, in a statement Thursday.

The allegation that the company’s phase 1 clinical trial on TEW-7197 had significant flaws comes after its stock plummeted 29.8 percent from the previous trading day to 13,900 won ($12.86).

The company explained that there were no issues that may have affected the stock price plunge.

“Also, the rumors that U.S. phase 1 clinical trial for Vactosertib by Medpactos, a subsidiary of Theragen Etex Bio Institute, had failed is not true,” a company official said. “The phase 1 clinical trial of Vactosertib in the U.S. was a success and had no serious adverse events or side effects.”

Medpacto has obtained sufficient data to demonstrate the safety of the drug in the trial, he added.

The company stressed that Medpacto is proceeding smoothly with phase 2 clinical trials based on the results of phase 1 clinical trial and is currently administering the agent to its participants.

“Although some patients showed symptoms of pulmonary edema during low dose administration, the problem did not appear during high dose administration,” the official said. “Therefore, the company believes that there is no direct correlation between pulmonary edema and Vactosertib.”

corea022@docdocdoc.co.kr

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