Amid the controversy over the concealment of ingredients, Kolon TissueGene, which is on the verge of being out of the market due to the Korea Exchange's decision to delist, submitted data for the resumption of the U.S. FDA's third phase of clinical trials for the suspended gene osteoarthritis drug, Invossa.
The phase 3 of clinical trial is a step that determines proper dosage by looking at side effects and efficacy of drugs for a large number of patients and is just before market authorization.
Kolon TissueGene said on Aug. 27 that it submitted a response material to a request for the lifting of the "clinical hold," which is listed in a clinical hold letter issued by the U.S. FDA to the company on May 3, 2019.
In May, the FDA earlier notified Kolon TissueGene of the suspension of clinical tests in connection with the "Invossa scandal," delivering the necessary requirements for the resumption.
On the data submitted to the FDA, Kolon TissueGene said, "They included the results of the verification tests on cell characteristics and the results of the corrective action plans, such as the improvement of the test and quality control system for the final product, and the evaluation of the safety of the product."
The U.S. FDA is expected to decide whether to resume the third phase of clinical trials as early as a month later. "The FDA usually has a 30-day review period for data submitted by our company, which is a developer," a Kolon TissueGene official said.
Kolon TissueGene also stressed that there is no problem in providing the necessary expenses for the resumption of the third phase of clinical trials. The third clinical trial, which is being pushed by Kolon TissueGene, will be carried out for about 1,000 patients, and it is known that an average of 100 million won per person is needed to recruit patients.
"It is possible under the current financial structure. On a first-quarter basis, cash and cash equivalents and short-term financial instruments are now 143 billion won, which does not necessarily require additional funding in clinical three phases," said the official.