UPDATE : Wednesday, September 18, 2019
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Sillajen likely to scrap global P3 trials for Pexa-Vec
  • By Lee Han-soo
  • Published 2019.08.02 10:29
  • Updated 2019.08.02 10:29
  • comments 0

Sillajen is in danger of aborting its phase 3 clinical trial for Pexa-Vec (trial name: PHOCUS) treating liver cancer.

The company said that it was advised to suspend the clinical trials by the Independent Data Monitoring Committee (DMC) which held a meeting to assess the futility of phase 3 clinical trial. The committee judges whether a candidate drug is worth developing based on whether it is potential as a treatment.

The company plans to report the DMC's recommendation to the U.S. Food and Drug Administration.

After Sillajen announced the possibility of it scrapping the phase 3 clinical trial, the company share plummeted to 31,200 won ($26) as of 10 a.m., a 30 percent drop from the previous trading day.

Pexa-Vec is an oncolytic viral therapy armed with a granulocyte-macrophage colony-stimulating factor gene that promotes an anti-tumor immune response.

The drug selectively targets and destroys cancer cells through three different mechanisms of action -- the lysis (breakdown) of cancer cells through viral replication, the reduction of the blood supply to tumors through vascular disruption, and the stimulation of the body's immune response against cancer cells.

The lead indication for Pexa-Vec is liver cancer.

corea022@docdocdoc.co.kr

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