NNVC Meets the US FDA For Pre-IND Meeting on FluCide. "All Hands on Deck" for 2013 Launch of a Worldwide Clinical Program for FluCide.
* On Mar 29 2012, NNVC met the US FDA for a pre-IND meeting for the clinical development of their nanoviricide product FluCide for the treatment of seasonal and endemic flu
* FluCide differs from currently available treatment options, like Tamiflu or Relenza, by sequestering the entire virus and removing it from circulation, rather than inactivating one viral protein at a time
* At its FDA meeting, NNVC presented all available "proof-of-concept" materials including preclinical efficacy and safety and preliminary animal toxicology data that they have collected so far
* In this meeting , NNVC sought the FDA's guidance on the following items:
o What additional toxicology studies are required: (i) types of animal species to test FluCide in, (ii) number of animals/species that need to be exposed (iii) duration of exposure
o Design of the phase I-III program and the need to use randomized trials against standard-of-care even in phase I/II stage
o The exact approval strategy in the US and the FDA's overall blessing on the ex-US approval strategy
* Ex-US strategy: NNVC's internal vision is that there be a combined phase I/IIa study, probably conducted by a US based CRO with subjects (N =~50) in Europe. Since the timing of the flu season in Europe is different from the US, conducting a study there allows adequate setup/legwork time for the CRO and provides a lower cost but equally robust option to NNVC
* NNVC also envisions that if the European trial is successful, a phase III program could be started in Australia, allowing the company to capitalize on the staggered flu seasons in different countries. This will be a much larger trial and may need to treat over 500-1000 patients
* US strategy: Since GMP approval standard for investigational drugs are more stringent in America than in EU or Australia, it is likely to take until mid-2013 for US trials to start
* The FDA advices NNVC to start US trials (maybe phase II/III) under an orphan drug program treating the sickest tranche of flu patients who are also immuno-compromised at outset
* Given that there are 250,000 hospitalizations for flu each year in the US, and a significant number of such patients are immuno-compromised, it is very clear that this sickest patient pool is an orphan designation (= 200,000 incidence/year)
* We believe this is a very interesting path to follow because FluCide's mechanism of action is by physically trapping the virus and making it unable to infect human cells; hence the presence or absence of a functional immune system should have no bearing on the efficacy of the drug. If proven, FluCide maybe the only flu agent that can work on such immuno-compromised patients—which could be a huge marketing leverage for NNVC
* Manufacturing plant: However, the important and rate-determining step towards the start of any clinical program for FluCide is the construction of the production plant in Connecticut
o NNVC has decided to hire contractors and builders who build the framework at their own plants, then deliver to the site in a modular fashion and then integrate on-site
o This ex-location production is both cost- and time- efficient and could be completed in five months from start date
o To oversee the construction and integration process, NNVC has retained a former head of worldwide manufacturing from Merck who is presently working with GMP consultants to seek their clearance before the proposed plan is sent off for modular construction
o NNVC management believes this plant will be ready to produce FluCide by YE2012 or 1Q2013
o At its optimal production capacity this plant will make 1 kilogram of GMP certificated FluCide/year, which is sufficient to supply 1MM doses of the drug/year
We believe that after the FDA meeting, toxicology studies will continue in parallel with the construction of the manufacturing plants. Both will conclude at the same time by YE2012 allowing for production of drug materials
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