Kolon TissueGene(950160) issued an official apology to shareholders after osteoarthritis treatment TG-C (formerly Invossa) suffered a setback in the first attempt at a phase 3 trial in the United States. Kolon TissueGene on the 27th released "A message to our shareholders," written under the names of CEOs No Mun-jong and Jeon Seung-ho.
Kolon TissueGene said, "We take this result very seriously and are painfully taking to heart shareholders' rebukes," adding, "We bow our heads in apology for causing deep disappointment." The company also said, "We will thoroughly identify the reasons we failed to demonstrate statistical significance in the first phase 3 study."
The company's position is that the second phase 3 results will be analyzed by an outside professional institution. Kolon TissueGene said, "We will have the results of the second ongoing phase 3 study analyzed by an external statistics firm with credibility," adding, "We will further strengthen objectivity and transparency." It added, "We will not rely on excuses or vague hope, and will share scientific data and every step with the market."
Kolon TissueGene plans to investigate suspicions that the stock price fell before the clinical results were announced. The company said, "We strictly banned employees from trading shares and maintained the highest level of security in the department handling clinical data," adding, "We will establish an independent investigative body to address the suspicions being raised."
Earlier, TG-C failed to meet its target in the first U.S. phase 3 study. Compared with before administration, patients' symptoms such as pain relief improved, but efficacy was not recognized because it was not confirmed to be better than placebo (a dummy drug). The company plans to disclose key topline indicators from the second U.S. phase 3 in Oct.