– ‘Approved’ for treatment purpose usage at Yonsei University Hospital after Seoul National University Hospital, Yeungnam University Hospital and Chungnam National University Hospital
Mar 30, 2020, 09:00 ET
CHUNCHEON, South Korea, March 30, 2020 /PRNewswire/ — ‘hzVSF v13 (humanized Virus Suppressing Factor; VSF)’, a treatment that can be used for a wide range of viral diseases developed by ImmuneMed, was administered on March 28th at Yonsei University Hospital to treat COVID-19 pneumonia patients. It was the fourth hospital where VSF was administered, following Seoul National University Hospital, Yeungnam University Hospital, and Chungnam National University Hospital.
The Korean Ministry of Food and Drug Safety (MFDS) approved the use of VSF for COVID-19 treatment for individual patient at Yonsei University Hospital on March 27th. The application for treatment use is the compassionate use system that allows doctors or companies to apply for and receive approval from the MFDS for individual or multiple patients who do not have an alternative treatment.
Previously, the two pneumonia patients who were administered the drug were given 2 or 3 doses of VSF and within 10 days, the virus disappeared and their pneumonia improved, eventually making a full recovery. According to ImmuneMed, the company recommends intravenous injection of 50-200mg on day 1, 3, 7 and 14 depending on the degree of pneumonia, and due to the rapid recovery after administration, it may not be necessary to administer the drug on day 7 or 14. Two patients at Yeungnam University Hospital, who began to be administered on March 19 and one patient at Chungnam University Hospital, who started on the 20th, had severe conditions requiring ventilator and ECMO treatment due to deteriorating pneumonia despite prescribing Kaletra, but showed rapid improvement after VSF administration. No side effects associated with VSF have been reported in these 7 pneumonia patients.
VSF is a drug under development as a treatment for chronic hepatitis B and severe influenza. Yoon-Won Kim, CEO of ImmuneMed, said, “We have been conducting evaluation studies so that the drug could be used when novel coronavirus diseases such as SARS and MERS would break out, and in this time COVID-19 breaks out, we have used it as a treatment of COVID-19.” The company conducted a phase 1 clinical trial of VSF to evaluate safety and pharmacokinetic properties after intravenous administration in 56 healthy volunteers. It was reported that there was no serious adverse event up to the highest dose of 1,200 mg.
ImmuneMed confirmed that inflammatory cytokine production was inhibited after administration of VSF in experimental coronavirus-infected mice. In particular, significant reductions in IFN-gamma, MCP-1, IL-6 and TNF-alpha were observed characteristically. A representative from ImmuneMed explained, “VSF increases the natural healing power of cells to suppress viral replication and reduce excessive immune response and inflammation, thereby showing therapeutic effect.”
ImmuneMed has applied to the MFDS for treatment on 25 multiple patients which would be led by the company, and is planning to launch clinical trials in Korea as well as abroad.
Sungpill Park, VP of Global Business Development
sppark@immunemed.co.kr
SOURCE ImmuneMed Inc.
