Genexine is soon to conduct a phase 2/3 trial of Covid-19 vaccine candidate GX-19N in Indonesia but has yet to register the study on ClinicalTrials.gov, a registry of global clinical trials. The company obtained Indonesian approval for the study in early July.
The South Korean biotech company said there was no change in its plan for the Covid-19 vaccine trial.
Korea Biomedical Review learned on Wednesday that Genexine has not registered the phase 2/3 trial of GX-19N in Indonesia on ClinicalTrials.gov, run by the U.S. National Institutes of Health (NIH).
The website allows access to information about clinical trials around the world.
If a company obtains FDA approval for a trial, it must register the clinical trial information on ClinicalTrials.gov.
If the approval came from regulators other than the FDA, most pharmaceutical and biotech companies register the information about clinical trials on the site voluntarily.
The registration of the trial can boost the credibility of the study and promote the pipeline.
An industry official explained why a drug company should register the clinical trial information on ClinicalTrials.gov and what effect the company could have.
“It brings an effect similar to an announcement of clinical results at an international conference,” the official said. “It is to send a signal to outsiders that the company is conducting this kind of trial.”
The registration could also help sign a partnership agreement with a foreign company, he added.
On July 7, Genexine said in a public filing that Indonesia’s National Agency of Drug and Food Control (Badan Pengawasan Obat dan Makanan) authorized its phase 2/3 trial of GX-19N and that it planned to register the information on ClinicalTrials.gov.
“We expect that the global phase 2/3 trial will prove GX-19N’s protective effect with T-cell immune response and verify the vaccine’s efficacy against virus variants amid the outbreak of unexpected Covid-19 variants,” the company said at the time.
A search for “Genexine” on ClinicalTrials.gov showed 35 studies on Wednesday. They include a local phase 1b trial of Covid-19 treatment GX-17, which won the regulatory nod in August, and a phase 1b trial of cervical cancer vaccine GX-199E.
Genexine said there was no change in the plan for the phase 2/3 trial in Indonesia. “It is a matter of time of registration. There is no problem in the study,” a company official said.