Drug maker NanoViricides (OTCBB:NNVC) Wednesday said that it has hired interior design company Id3A as the architect for its laboratory and cGMP pilot production facility project.
Shares of the company moved up 3.23 per cent as at about 10 a.m. EDT, trading at 48 cents.
The company’s cGMP (current good manufacturing practice) facility is being designed to produce sufficient quantities of the drugs needed for human clinical trials testing various nanoviricide drug candidates as they advance into the clinical pipeline.
Last month, NanoViricides announced that the facility will be built by renovating an existing 18,000 square foot light manufacturing plant on a 4.2 acre lot in Shelton, Connecticut.
The company said Id3A, as the architects for the project, will be responsible for the overall facility, including the integration of a separately constructed “clean room suite” for cGMP production.
Id3A’s co-founder, Kathyann Cowles, will serve as the principal architect for the project and will join Andrew Hahn and Phil Mader of MPH Engineering to complete the architecture, design and construction management team.
Cowles has over 30 years of experience as a licensed architect and senior project manager for design and construction projects in the academic, science, technology, corporate and research sectors, the company noted.
“[Ms.] Cowles has a unique ability to work with clients in meeting complex and detailed requirements,” said NanoViricides president Anil R. Diwan, PhD.
“This is critically important for our challenging project that specifies not only state-of-the-art facility requirements, but also cost sensitivity, space efficiency, and a high degree of energy efficiency.”
The drug substances produced in the company’s new facility will be delivered to a third party for final processing and labeling, as required, for human clinical trials when ready.
The development stage company is developing its NanoViricides class of drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal influenza, HIV, oral and genital herpes, viral diseases of the eye, Dengue fever, and Ebola virus, among others.
It is focused on advancing its FluCide drug candidates through the regulatory process, and has already designed the toxicology and safety pharmacology studies for the IND submission and the first-in-human clinical trials of its FluCide investigational anti-flu product.
The company is now conducting further studies that are necessary before producing large batches for the safety and toxicology studies. The injectable anti-flu drug, NV-INF-1 is intended for use in hospitalized patients with the flu, and the company believes it could receive an orphan drug classification for use in immuno-compromised patients.
NanoViricides has also developed an oral anti flu drug candidate, NV-INF-2, which it has said may be the "first ever nanomedicine drug of any kind that is active when administered orally."
The drug is being developed for out-patient flu cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers.
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