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Tuesday, 13 November 2012
NanoViricides inks deal with Bioanalytical Systems for safety, toxicology studies needed for FDA submission
NanoViricides (OTCBB: NNVC) says it has agreed with Bioanalytical Systems (NASDAQ:BASI) to conduct drug development studies required for submitting investigational new drug applications (IND) for its NanoViricides to the FDA.
The development stage company is developing itsNanoViricides 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.
First off, the drug maker is focused on advancing its FluCide drug candidate through the regulatory process.
The company 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.
Meanwhile, Bioanalytical will conduct the current good laboratory practices (cGLP) and non-GLP studies as required, which are designed to assess the overall safety in animals receiving multiple doses of FluCide.
Specific safety pharmacology studies will also be done to assess the effects of FluCide on the cardiovascular, respiratory and central nervous systems.
These studies are required for US FDA IND submission, as well as for applications to conduct human clinical trials in other countries such as Australia.
NanoViricides has previously reported successful results of its FluCide drug in pre-clinical animal studies, using two different types of influenza A - H1N1 and H3N2. It has also reported that the drug candidates have been "extremely safe" in the animals tested.
In fact, last month, it said that recent findings showed that its oral FluCide drug is “at least 10 times superior” to oral oseltamivir, or Tamiflu, in protecting the lungs of mice with a lethal H3N2 flu virus.
The company plans to conduct more efficacy studies as required for the investigational new drug application, in parallel with the safety/toxicology studies.
The drug maker anticipates that it will need large quantities of the drug candidate for these "tox package" studies, and is now performing scale-up studies to produce the necessary quantities.