67 WALL STREET, New York - August 29, 2012 - The Wall Street Transcript has just published its Medical Research, Diagnostic Substances and Life Science Tools Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Health Care Consolidation Activity - Cost Reduction and Improving Efficiencies - Chinese CRO Growth - NIH Budget Uncertainty
Companies include: NanoViricides (NNVC) and many others.
In the following excerpt from the Medical Research, Diagnostic Substances and Life Science Tools Report, the CEO of NanoViricides discusses the outlook for his company for investors:
TWST: Would you provide us with a brief summary of where the company is right now?
Dr. Seymour: As you know, we have developed a platform technology to rapidly create drugs to destroy viruses in and around the body. We have nine drugs in our pipeline, tested in a total of 4,000 animals, and the first one that's going to humans is our drug for the flu. It's important to note that we're independent of the host since we only work in the circulation, not within cells.
In addition, we've just announced that an oral preparation of FluCide, our influenza drugs, which has been found to be effective.
We're awaiting more data from the laboratory that did the research work but this suggests to me that not only do we have the possibility of a cure for all forms of influenza A, but we have a drug that can be taken orally and function as a prophylaxis against the flu. We are starting toxicity studies shortly, and our plan is to be in humans in Australia next year.
We are working on building a facility that can manufacture the drug under certain specific conditions, called GLP, good laboratory practices, so we can use that material for our human trials. The plan is to do 25 patients for safety as Phase I, and then, a Phase IIa, that would be a viral challenge study. In that, 25 healthy volunteers are infected with the virus, then isolated and treated. We'd then move to IIb, which expands the number of patients treated - hospitalized patients. And then eventually, Phase III is a larger-scale study. Those are our immediate plans. We have enough capital to run the company for approximately two years, so we are well positioned financially.
TWST: And NanoViricides met with the FDA in late March?
Dr. Seymour: That's correct. They gave us guidance on what they wanted, and that was about what we expected. Since we are claiming that FluCide works against all forms of influenza A, they want us to test it against all the different viruses in the universe. There are 16. We've already done H1N1, swine flu; we've done H5N1, bird flu; and we've done seasonal flu. We're in the process now of sourcing the viruses to round out the spectrum to test the effectiveness of the drug.
TWST: You've said the company will be able to produce drugs for the human clinical trials when the renovation of a manufacturing facility is concluded. Where does that stand?
Dr. Seymour: Right now, we're in the final design phase. It goes to the city of Shelton, Conn., planning and zoning, and at the same time, it goes out to bid. As soon as we have approval to start and we have satisfactory bids, we'll start the building process, which is really a renovation of the existing 18,000-square-foot building that we have.
TWST: Any sense of what the whole timeline looks like as far as getting approval? It is typically a three-year process, right?
For more from this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.