NanoViricides (OTCBB:NNVC) said Monday that it has retained Australian Biologics, a regulatory affairs consulting firm, to coordinate the regulatory review and approval for the first human trials in Australia for its broad-spectrum anti-flu drug, Flucide.
Shares were up 6.36 per cent to 57 cents Monday afternoon.
Australian Biologics will also facilitate clinical trial site/s selection, and the development of the clinical trial agreements.
"We are very pleased to engage Jim and his staff because of their
extensive experience in both the regulatory and operational aspects of
the clinical trials landscape in Australia,” said NanoViricides CEO, Eugene Seymour.
said that the manager of Australian Biologics, Dr. Jim Ackland, was
previously the vice president of the West Coast and Asia Pacific
operations for the Biologics Consulting Group.
Biologics Consulting is NanoViricides' U.S. FDA regulatory affairs consulting group.
said it anticipates that it will be able to produce drugs suitable for
human clinical trials when renovation of its new facility in Shelton is
Australian Biologics will also help the drug company study and
develop a plan for conducting certain phase 1 and phase 2 human clinical
studies in Australia.
NanoViricides announced at the end of June that it raised $5.0 million drawing down on its previously announced registered shelf offering.
The funds give NanoViricides
the ability to settle certain testing costs for its anti-influenza drug
candidate and to support the costs of additional equipment needed for
the production of future clinical batches of its drug candidates.
In early April, the company said that the U.S. health regulator gave a
"good roadmap" toward an investigational new drug (IND) application for
FluCide at a pre-IND meeting.
The company said it received comments and exchanged a list of
questions with the FDA prior to the meeting, and believes the health
regulator has given the company a good roadmap for advancing the drug
toward an investigational new drug application.
NanoViricides' nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them.
Drugs are currently being developed against viral diseases such as
H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital
Herpes, and other viral diseases.
The company now has five drug development programs within its
pipeline, including FluCide, a drug that works against all forms of
influenza such as seasonal and epidemic flus, and HIVCide, a drug that
works against the HIV/AIDS virus, which the company says could become a
"functional cure" for the disease.