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Tuesday, 6 August 2013
NanoViricides signs second NDA for IND-enabling FluCide studies
NanoViricides (OTCBB:NNVC) has signed a non-disclosure agreement with the Lovelace Respiratory Research Institute as part of its plan to conduct drug studies of both its broad-spectrum injectable and oral FluCide candidates.
The company is planning to sign a master services agreement with New Mexico-based Lovelace, a private biomedical research organization, for the efficacy studies to be conducted in advance of the investigational new drug (IND) application.
The studies will use multiple unrelated subtypes and strains of influenza A, including the H7N9 strain, which is currently circulating in China. NanoViricides has already proven, through animal studies, that both versions of its FluCide drug candidate are more effective than the current standard of care, Tamiflu, in controlling influenza A virus infections, namely H1N2 and H3N2.
In addition to FluCide, Lovelace will also be able to test the company's anti-MERS (Middle East Respiratory Syndrome) drug candidate in cell culture and animal models when available. As recently as June, the Obama administration designated MERS as a potential threat to public health and national security.
The NDA allows the two parties to exchange confidential and proprietary information in preparation for the intended studies.
NanoViricides' injectable FluCide drug is designed for severely ill hospitalized patients, while the oral version is aimed at outpatient use. On the advice of the FDA during the company's pre-IND meeting, it will test both drugs against several unrelated subtypes of influenza A, including H7N9, which is considered a potential pandemic threat.
The drug development company, which has six commercially important drug candidates in its pipeline that together address a market size of greater than $40 billion, recently executed another NDA with the UK Public Health Agency for the testing of its FluCide candidate against the A/H7N9 strain as well as new drug candidates against the emerging MERS virus.
NanoViricides said in a statement Monday that it believes that independent testing of the drug candidates at these two sites should result in a dataset that yields a "high degree of confidence". Its FluCide drug has the potential to wipe out virtually all strains of the pesky influenza A virus, with toxicology studies expected to be wrapped up before the middle of next year.