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Monday, 10 December 2012
NanoViricides appoints engineering firm for cGMP facility, anti-flu program development ongoing
Drug maker NanoViricides (OTCBB: NNVC) says it has retained MPH Engineering to help with the overall project management and design of its new lab and pilot production facility.
The cGMP (current good manufacturing practice) facility will be built by renovating an existing 18,000 square foot light manufacturing plant on a 4.2 acre lot in Shelton, Connecticut.
MPH will provide overall engineering and project management services for the whole facility, as well as the design and construction phases. A separate firm will be designing the cGMP area itself, while MPH will be responsible for the implementation of the entire project.
The services from MPH will be headed by Phil Mader, the director of engineering at the firm, who has 26 years of mechanical, electrical design and construction leadership experience. NanoViricides noted that major clients of the firm include Bristol-Myers Squibb.
"Mr. Mader is uniquely qualified to ensure delivery of this complex laboratory and cGMP manufacturing suite project for us," said company chairman and president, Anil R. Diwan.
"He has extensive experience in working with various engineering and construction firms and ensuring detailed attention to critical aspects of the project."
Prior to founding MPH, Mader was the senior capital project manager at Bristol-Myers in Wallingford, Connnecticut.
NanoViricides' cGMP pilot plant is being designed to produce sufficient quantities of the drugs needed for human clinical trials testing various nanoviricide drug candidates as they advance into the clinical pipeline.
The development stage company is developing its NanoViricides 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.
It is now conducting further studies that are necessary before producing large batches for the safety and toxicology studies. The injectable anti-flu drug, NV-INF-1 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.
The company has also developed an oral anti flu drug candidate, NV-INF-2, which it has said may be the "first ever nanomedicine drug of any kind that is active when administered orally."
In October, 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.
Once the new facility is complete, the company said it will be able to produce sufficiently large batches of its oral anti-flu drug for further development. As the company develops data for an IND submission for its two flu candidates, it will be required to produce the drugs under cGMP conditions.
The company added that it also plans to pursue human clinical trials in countries other than the USA, which may not require the drugs to be manufactured in a registered cGMP facility.
Both the oral and injectable versions of the drug have shown "high efficacy" in preclinical animal trials, against two different influenza A strains tested.
NanoViricides said in its statement: "The company believes that these drugs will be effective 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."
As of September 30, the company had around $12.93 million in cash and equivalents, and around $438,000 in prepaid expenses.