Tuesday, 20 November 2012

NanoViricides armed with $12.9 mln in cash to advance its FluCide program; enough for IND submission

NanoViricides (OTC: NNVC) has filed its quarterly report, and says that it has sufficient cash in hand to support operations for at least two years at the current rate. 
The company reported that as of September 30, it had around $12.93 million in cash and equivalents, and around $438,000 in prepaid expenses. 
This compares with $14.27 million in cash and equivalents at the end of June, and around $314,000 in prepaid expenses. 
The drug developer said its rate of expenditure was in line with its budgeted targets, and it has been successful in raising additional capital as needed. It also said that its drug development programs are progressing as planned. 
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 candidates 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. 
NanoViricides said that its oral FluCide, NV-INF-2, may be the "first ever nanomedicine drug of any kind that is active  when administered orally."
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 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. 
The company also continues to develop its injectable anti-flu drug, NV-INF-1, toward IND-enabling studies. This drug 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 said in its statement: "The company believes that these drugs will be useable against most if not all types of influenza viruses, including seasonal, epidemic, novel strains, and bird flu. In addition, both of these drugs have shown extremely good safety profile in limited animal studies."
The drug maker is working on a "substantial scale-up" in its current synthesis capabilities, and is also working on acquiring current good manufacturing manufacturing practices (cGMP) standard for these drug candidates. 
With its current cash position, NanoViricides said it believes that it has enough funds to perform the necessary IND enabling studies for its anti-influenza drug programs and to file an IND with the US FDA.
Including the FluCide program, the company currently has six "commercially important" drug candidates in its pipeline, which are based on its platform technology that specifically targets a particular type of virus. 

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