The government said it has approved three investigational drugs to treat a limited number of more than 10 patients infected with the new coronavirus (COVID-19) so far.
The Ministry of Food and Drug Safety regulator gave the latest nod to GemVax & Kael’s GV1001, an experimental drug for Alzheimer’s disease. On Friday, the regulator allowed Kyungpook National University Chilgok Hospital to use GV1001 to treat two COVID-19 patients.
On March 30, GemVax & Kael announced that it applied for a patent on GV1001 to be used as COVID-19 treatment. GV1001 is a peptide derived from human telomerase reverse transcriptase, an enzyme that maintains the length of telomeres at the ends of human chromosomes. The agent demonstrated the effect of preventing the cytokine storm caused by COVID-19 in preclinical studies, the company said.
As GV1001 has not only anticancer effects, but various other effects such as anti-inflammation, anti-oxidation and cellular protective effects, the drug might work against COVID-19, too, the company said.
The regulator grants approval for investigational medicines for therapeutic purposes for individual patients on the condition that there is no other treatment option, and the patient suffers from a life-threatening disease. The authorities have given such nod to three drug candidates, including GV1001, to be used for more than 10 COVID-19 patients.
A second approval went to ImmuneMed’s experimental drug, hzVSF (humanized virus suppressing factor), to be used for seven patients in Seoul National University Hospital (SNUH), Yeungnam University Medical Center, Chungnam National University Hospital, and Severance Hospital. Pharmicell also obtained the nod for Cellgram-AKI, a stem cell therapy, for the treatment of up to 24 COVID-19 patients.
As the government gave the latest nod for COVID-19 treatment only for compassionate use, the approval does not mean that the three investigational drugs proved efficacy and safety.
The hospitals using the three experimental treatments do not control the drug administration or establish a control group because they do not intend to evaluate the candidates’ efficacy and safety.
Seeking approval for therapeutic purposes for individual patients requires only a specialist’s opinion and a medical certificate. In that case, the attending doctor is responsible for the use of the investigational drug.
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