Sillajen announced its official position on August 4 on the decision to end the development of a new drug anti-cancer drug candidate substance "Pexa-Vec" for liver cancer.
"We've stopped three clinical trials because we've accepted the data and safety monitoring (DMC) recommendation," said an official from Sillajen.
DMC refers to a group of experts who monitor patient safety and drug efficacy data in clinical trials at an ongoing stage. Pharmaceutical officials said the DMC plays a vital role in the clinical three-phase stage as an intermediate check, as the clinical trial itself is long.
In the course of clinical design with the U.S. Food and Drug Administration (FDA), Sillajen has already decided to receive DMC futility analysis in the three phases of clinical trials. If Silajen does not receive the DMC's futility analysis results this time, it will not be able to obtain approval for the new drug from the FDA.
After clinical trials were conducted in which "Pexa-Vec" and Bayer's liver cancer treatment "Nexavar" were used together, and in which cases treated alone in Nexavar, Sillajen proceeded to compare the two clinical trials.
The third phase of clinical trial was planned for 600 patients with liver cancer who were taken out of New Zealand, the United States and South Korea. But unlike the animal test results, "administering Nexavar after administering Pexa-Vec was not effective for liver cancer patients," Sillajen said.
Due to the suspension of the third phase of the clinical trial, Silajen, which was inflated by expectations of the development of a new drug for anti-cancer drugs, took a considerable hit on the market. The market capitalization of Silajen, which evaporated on August 2 in just one day, amounts to about 1 trillion won (US 830 million dollars).
"We can turn the tide in the development of the remaining new drugs," said an official at the Silajen. However, the new drugs are also based on Pexa-Vec, so the negative impact cannot be ruled out, industry sources say.
Kwon Hyok-san, executive director of clinical development of Sillajen, stressed "early-ended clinicians are just one of the ongoing clinical trials, and the Pexa-Vec is not a useless drug."
Regarding the allegation that the company knew about the futility analysis in advance but hid it, "If clinicians proceed, the company will not be involved at all," said Moon Eun-sang, the CEO of Sillajen. "The moment the company is found to be involved, the data is nullified, I still don't know why the DMC recommended the suspension."
Regarding the case that Shin Hyun-pil, executive director of Sillajen, sold 167,777 shares of his personal holdings over four occasions prior to the utility analysis announcement, "I think it's an individual deviant behavior," Moon said. "company is in the process of advising him a resign."
Meanwhile, the Korean bio market is facing a crisis as a series of cases have recently failed to surpass the three-phase barrier of global clinical trials. In late June, bio-venture HLB announced the failure of the global clinical three-phase of riboceranib for late-stage stomach cancer patients. Kolon Life Science's osteoarthritis gene therapy Invossa-K has also been suspended due to controversy over its cover-up of ingredients.