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Monday, 19 August 2013
NanoViricides' production plant renovations on track
NanoViricides (OTCBB:NNVC) said today the renovation of a facility that will house an FDA-standard production plant is on schedule.
The news pleased investors, who sent shares soaring 2.7%, building on a torrid 130% pace so far this year.
The Shelton, Conn. clinical-scale plant -- which is built according to current good manufacturing practice, or cMGP, an FDA regulation that calls for proper design, monitoring and control of manufacturing processes and facilities -- is now in the construction phase.
Last month, the West Haven, Conn.-based company finished demolition. Construction has ramped up since it began early August so that it can meet a target December completion date.
NanoViricides, which develops drugs for patients suffering from life-threatening viral infections like bird flu and HIV/AIDS, said the design, engineering and architecture for the facility were completed at the end of June.
The company said the schedule may face delays if it does not receive certain equipment "in a timely manner."
Additionally, NanoViricides also said it has begun sub-kg scale production of its anti-influenza drug candidate, FluCide. Large amounts of the drug are needed for safety and toxicology studies, which will begin when enough is produced.
The company said the injectable and oral FluCide drug candidates have shown "strong effectiveness against distinctly different subtypes of influenza viruses, namely H1N1 and H3N2, in highly lethal animal models," a sign they have a broad reach.
Injectable Flucide has shown a thousand times greater viral load reduction compared to Tamilflu, while the oral version also demonstrates improvements over the on-the-market counterpart.
Further Flucide testing will occur at Public Health England and the Lovelace Respiratory Research Institute in New Mexico, both of which signed confidentiality agreements.
NanoViricides' pipeline includes early-stage treatments for bird flu, herpes and Dengue fever.