FDA nixes Kolon clinical trialsU.S. Food and Drug Administration (FDA) rejected Kolon TissueGene’s request to resume Phase 3 clinical trials for its controversial gene therapy drug Invossa.
This could spell doom for both Invossa and the company, which could be delisted from the stock exchange. Trading has been suspended for months.
The biopharmaceutical affiliate of Kolon Group announced in a regulatory filing Monday that the U.S. drug authority ordered trials for Invossa to remain suspended and asked its manufacturer to submit additional data on the drug’s ingredients if they wanted to resume the trials.
Kolon TissueGene submitted an application to the FDA late last month to resume Phase 3 clinical trials in the United States for Invossa, a gene therapy drug for knee arthritis. The trials were put on hold since it was found that the drug was using kidney cells instead of the cartilage cells the manufacturer reported to the Ministry of Food and Drug Safety when seeking approval for commercialization in 2017.
The Korean drug authority officially revoked the license for Invossa in early July. Invossa is the only drug Kolon TissueGene has made, which means it is the only hope for the company and its investors to make any money.
Kolon TissueGene said in the regulatory filing that the FDA asked the company to submit additional analysis on its base cells and whether tumor-inducing agents are present in the final product.
Since being taken off the market in Korea, Invossa was accused of potentially causing tumors, as the kidney cells can grow and multiply, while cartilage cells would die after a certain period.
Kolon Life Science, parent company of Kolon TissueGene, has denied this risk and said it has used radiation on the drug to prevent its cells from multiplying out of control.
The FDA also recommended Kolon TissueGene continue with its plan to track the long-term health effects on patients injected with Invossa. Kolon Life Science announced in July it will track the health effects of the drug on 3,853 patients over 15 years. The company is spending more than 50 billion won ($41.9 million) to administer 10 different tests on patients at 20 major hospitals across the country.
Kolon TissueGene said it will file all data requested by the FDA.
The rejection by the FDA suggests Kolon TissueGene may not remain long on the secondary Kosdaq bourse.
After voting to delist the drug company for false documentation in late August, the Korea Exchange (KRX) has until Oct. 11 to confirm the ruling and continue the delisting process. The exchange was supposed to make a decision last week but postponed a meeting to consider the FDA’s response to Kolon TissueGene’s request to resume clinical trials.
A delisting is expected to hurt all investors, including 59,400 minority investors who hold 4.51 million shares, or 36.6 percent, of Kolon TissueGene.
Kolon TissueGene first traded on the Kosdaq in November 2017 and once saw its shares reach 75,100 won, giving it a market capitalization of more than 4 trillion won. But since the KRX suspended trading on May 31, shares have been frozen at 8,010 won, giving the company a market capitalization of 489.6 billion won.
BY KO JUN-TAE [firstname.lastname@example.org]