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Broad-Spectrum Antiviral Drug NV-387 Cleared for Phase II Clinical Trial Application by the National Ethics Committee of the Democratic Republic of Congo
SHELTON, CT / ACCESS Newswire / May 8, 2025 / 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 ...
About this update from Nanoviricides, Inc.
[{"type":"text","content":"SHELTON, CT / ACCESS Newswire / May 8, 2025 / 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").","length":574,"tagName":"p"},{"type":"text","content":""We are now fully engaged in completing the detailed CTA for the Phase II human clinical trial of NV-387 for the treatment of MPOX disease (hMPXV infection) for submission to the DRC Regulatory Agency, namely MSP," said Anil R. Diwan, PhD, President and Executive Chairman of the Company.","length":298,"tagName":"p"},{"type":"text","content":"The Company previously announced in January, 2025 that it has engaged a CRO for conducting a Phase II clinical trial to evaluate the safety and effectiveness of NV-387 for the treatment of MPox in the African Region.","length":216,"tagName":"p"},{"type":"text","content":"Subsequently, the CRO has engaged the Medical Hospital at the University of Kinshasa as the clinical trial site (the "Site") for the Phase II clinical trial.","length":167,"tagName":"p"},{"type":"text","content":"Thereafter, the Company, the CRO, and the Principal Investigator at the Site have developed a package of information comprising synopses of the clinical trial protocol, and required background information on the novel drug NV-387, including a draft summary report of the Phase I human clinical trial, prior non-clinical data, as well as summary of the animal model effectiveness and safety of NV-387 for the treatment of lethal MPox infection providing rationale for the use of the novel broad-spectrum antiviral drug NV-387 for the treatment of hMPXV viral infection and the MPox disease caused by the infection.","length":613,"tagName":"p"},{"type":"text","content":"This summary package was submitted to the National Regulatory Agency's Ethics Committee CNES for a first review towards approval to proceed to the preparation and submission of the detailed CTA to the National Regulato...