NanoViricides R&D lab and cGMP pilot production plant near completion
Also raises US$20m to accelerate development of its six antiviral drug candidates
NanoViricides, a US-based developer of nanomaterials for use in antiviral drugs, is nearing completion of its modern R&D lab and cGMP clinical production facility in Shelton, Connecticut.
The R&D lab section of the facility is ahead of schedule, while the construction of the cGMP cleanroom production suite is expected to be completed in March. The project will enter facility testing and the validation phase shortly after.
'Our urgency to bring this facility online has increased with the new wave of H7N9 Influenza A infections in China this year,' said Eugene Seymour, Chief Executive of NanoViricides, which is developing a treatment called FluCide for H7N9.
Anil Diwan, President and Chairman of NanoViricides, added that the broad-spectrum FluCide should be an excellent treatment for H7N9.
'This FluCide drug candidate was designed to mimic both the bird and human variants of the sialic acid receptors on cells to which the influenza virus binds,' he said.
'FluCide has shown extremely strong activity in animal studies against both Group I and Group II Influenza A viruses. Thus we fully expect it to work against H7N9.'
The broad-spectrum FluCide should be an excellent treatment for H7N9
NanoViricides plans initially to start production of FluCide in the new cGMP production facility, produce multiple batches under cGMP conditions, and demonstrate equivalence of the batches produced in preparation for human clinical trials.
The company intends to begin human clinical trials at the earliest opportunity after completing the Tox Package studies, and is evaluating all available options.
In a separate announcement, NanoViricides said it has raised US$20m after selling shares. It will use the proceeds for general business purposes and to accelerate the development of its drug candidate pipeline. In addition to FluCide and DengueCide, the company is developing four other drug candidates: Oral FluCide, HerpeCide, HIVCide and EKCCide.
The firm says the injectable and oral FluCide drug candidates have already shown strong effectiveness against different subtypes of influenza viruses, namely H1N1 and H3N2, in highly lethal animal models. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction than oseltamivir (Tamiflu).
The oral FluCide is also dramatically more effective than TamiFlu in these animal studies and could be the first nanomedicine to be effective when taken by mouth, the company said. These animal model results of both injectable and oral FluCide drug candidates should also translate readily into humans.
NanoViricides has recently signed confidentiality agreements with Public Health England (PHE-UK) and the Lovelace Respiratory Research Institute, New Mexico, US (LRRI) to carry out the remaining IND-enabling studies of FluCide.
