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2025-05-08 18:39
NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company") today reported that it has received approval from the National Ethics Committee for Health (CNES) of the Ministry of Public Health (MSP), of the Democratic Republic of Congo (DRC). With this CNES approval, the proposed Phase II clinical trial to evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection is cleared for further regulatory filing of a complete Clinical Trial Application ("CTA").
The approval that we have now received from CNES clears the path for the perfected CTA filing to the MSP for approval and start of the clinical trial.
There is no drug available for the treatment of hMPXV infection that causes the MPox disease. A clinical trial of tecovirimat (TPOXX®, SIGA) failed to demonstrate any effectiveness over placebo, as per a NIH press release on August 15, 2024.