GV1001 developed as a demetia drug, approved for COVID-19

The MFDS, approved for use from Kyungpook National University Chilgok Hospital

GemVax, completed patent application and product provision for COVID-19 treatment

The Ministry of Food and Drug Safety approved a new drug candidate 'GV1001' by GemVax, which is being developed as a treatment for dementia, for the purpose of treating COVID-19 patients.

 

The request for approval for the use of treatment was made by Kyungpook National University Chilgok Hospital.

 

The MFDS approved the use of GV1001 (Tertomotide HCl), applied by Kyungpook National University Chilgok Hospital on the 3rd, for COVID-19 confirmed patients.

 

Kyungpook National University Chilgok Hospital applied for two cases, and two patients received GV1001.

 

GemVax, which is developing GV1001, said that GV1001 has applied for a patent related to COVID-19.

 

GV1001 is a peptide derived from hTERT (Human Telomerase reverse transcriptase).

 

The enzyme telomerase maintains the length of telomere located at the ends of chromosomes, and the treatment has anti-inflammation, anti-oxidation cellular protective effects, as well as anti-cancer effect.

 

GemVax is currently conducting clinical trials to develop Alzheimer's treatments.

 

GemVax explained that GV1001 proved through preclinical studies to prevent cytokine storms by regulating various inflammatory mediators such as cytokines against severe inflammation caused by COVID-19 infection.

 

The approval for the use of treatment is a system that enables the use of clinical trial drugs for treatment purposes in order to provide treatment opportunities to patients with life-threatening diseases without other means of treatment.

 

In other words, it is different from commercialization clinical trials for product approval for large-scale patients, or sponsor-investigator trials conducted by researchers to prove effectiveness or safety.

 

Approval of use for treatment purposes requested by the hospital is permitted for individual patients, and at the time of application by the company, two or more persons are permitted.

 

Therefore, there is not enough data to demonstrate the effectiveness or safety of the therapeutic use.